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Medtronic Insulin Pump Lawsuits

Medtronic Insulin Pump Lawsuits

Drug Dangers Defective Medical Devices Medtronic Insulin Pump Lawsuits The Medtronic insulin pump is a medical device that makes it easier and more convenient to receive a daily dose of insulin. It consists of a small box about the size of a cell phone which can be kept in the pocket or worn on a belt. The pump delivers insulin through an infusion set which is connected to a cannula placed under the skin of the abdomen. In addition to making insulin administration more convenient, the Medtronic MiniMed insulin pump system provides a continuous supply of insulin which is intended to closely match the function of a healthy pancreas. The pump can also deliver on-demand or preprogramed boluses of insulin based on diet and blood sugar demands. In a person with a healthy pancreas, the body naturally produces insulin to utilize sugar absorbed in the diet and maintain energy levels. In people with diabetes, this system does not function correctly. In type 1 diabetes, the pancreas cannot make insulin and replacement therapy must be used. Type 2 diabetics may be able to secrete insulin, but the body does not respond to it as it should. They may be unable to make enough, or body cells have become resistant. In some cases, diet and medications may be sufficient to control blood sugar but in other cases, insulin therapy may be required. When a diabetic is insulin dependent, he or she must supply the body with insulin from an outside source usually an injection. For patients who use insulin injections, sometimes multiple daily injections are required to control blood sugar. The pump has replaced the needs for many people, providing a more convenient and hygienic method for insulin administration. Unfortunately, some Medtronic insulin pump users have experienced insulin overdose due Continue reading >>

Medtronic Minimed Infusion Sets

Medtronic Minimed Infusion Sets

URGENT MEDICAL DEVICE RECALL INFORMATION Because the safety of our customers is our top priority, we are voluntarily recalling specific lots of infusion sets used with Medtronic insulin pumps. Explanation of the Issue Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk. Actions Required by You Go to to determine if you have recalled infusion sets. You will be prompted to enter the REF and LOT numbers for all infusion sets in your possession. The website will then tell you which infusion sets are part of this recall and which are not. Your REF and LOT numbers are listed on the labels as shown in the examples below: If you have new and enhanced infusion sets that are not part of this recall, use only those sets starting with your next set change. As a reminder, we have Key Steps regarding the priming/fill-tubing process. If you only have recalled infusion sets right now, it is very important that you carefully follow the Key Steps. Return your recalled infusion sets within the next four weeks the pre-paid label that has been sent to you. Medtronic will replace the recalled infu Continue reading >>

Tga - Therapeutic Goods Administration (via Public) / Medtronic Minimed Infusion Sets

Tga - Therapeutic Goods Administration (via Public) / Medtronic Minimed Infusion Sets

09/15/2017 | News release | Distributed by Public on 09/14/2017 22:39 Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, is recallingspecific lots of Medtronic MiniMed infusion sets, including MiniMed Quick-set, MiniMed mio, MiniMed Silhouette and MiniMed Sure-T. Medtronic MiniMed infusion sets are used in conjunction with an insulin pump to deliver a continuous dose of insulin to help people with diabetes maintain normal blood glucose levels. There have been recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycaemia (low blood glucose level), which can lead to serious health complications. Subsequent investigations have found that this issue may be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol or water is spilled on the top of the reservoir or inside the tubing connector, which could prevent the insulin set from working properly. Updated infusion sets contain a new and enhanced membrane material that significantly reduces this risk. People who have Medtronic MiniMed infusion sets are instructed to check the lot numbers either by visiting a Medtronic website or by calling Medtronic to see if their products are affected (see the 'Information for consumers' or 'Information for health professionals' sections below for further details). Medtronic Australasia has written to consumers who have Medtronic MiniMed infusion sets to provide further information about this issue, include details of the recall procedure and instructions regarding the priming/fill-tubing process (called 'Key Steps'). If you or someone you provide care for us Continue reading >>

Medtronic Product Recall

Medtronic Product Recall

Medtronic has placed a recall on insulin pump infusion sets. This voluntary recall is the result of the discovery of potential overdose when the site is inserted. Reports quote the Medtronic Diabetes CMO stating that there is a potential for a complication to occur when a membrane that’s used to release pressure from inside the pump gets wet and blocks the vents. The risk of an excessive insulin dose is greatest right after the patient changes the infusion set, which is done every three days, she said. According to Medtronic, the reported incidence rate requiring medical assistance related to this issue is less than 1 in every 2 million infusion sets. Medtronic is replacing any sets that are affected, and they have set up a website that you can use to check. No matter what country you live in, you should confirm if any of your sets are part of the recall. We have checked, and the process is easy. Unfortunately all of our sets need to be replaced, but we are pleased that Medtronic has disclosed this and they will replace any recalled sets for free. The letter from Medtronic can be found here. To see if your sets are in the recall, visit Continue reading >>

News - Local News: Sudbury News, Suffolk, Best Site For What's On, Events And News (sudbury)

News - Local News: Sudbury News, Suffolk, Best Site For What's On, Events And News (sudbury)

"A great venue with fabulous Events, recommended " "Is really good to see that a local daily news and whats on site has been launched in Sudbury, well done Nick" Medtronic recall MiniMed infusion sets following reports of over-delivery of insulin in Sudbury Medtronic recall MiniMed infusion sets following reports of over-delivery of insulin The following notice has been issued by the manufacturer: Because the safety of our customers is our top priority, we are voluntarily recalling specific lots of infusion sets used with Medtronic insulin pumps. Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk. Go to to determine if you have recalled infusion sets. You will be prompted to enter the REF and LOT numbers for all infusion sets in your possession. The website will then tell you which infusion sets are part of this recall and which are not. Medtronic recommends you not use recalled infusion sets. If you have new and enhanced infusion sets that are not part of this recall, use only those sets starting with your next set change. As a reminder, we have Key Steps regarding the pri Continue reading >>

Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets

Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets

Medtronic Canada, a subsidiary of Medtronic plc (NYSE:MDT), announced today that Medtronic has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps and glucose sensors. The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change. The company will work with patients to ensure recalled infusion sets with the discontinued component are returned and replaced with new infusion sets containing the updated component at no cost. Medtronic has contacted the U.S. Food and Drug Administration (FDA), along with Health Canada and other regulatory bodies around the world, to share information related to this issue. Medtronic will continue working directly with government and regulatory authorities on this global voluntary recall. "Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients,” said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic “Our Med Continue reading >>

Medtronic Australasia Pty Ltd — Medtronic Minimed Infusion Sets Including Minimed Quick-set, Minimed Mio, Minimed Silhouette And Minimed Sure-t (specific Lots)

Medtronic Australasia Pty Ltd — Medtronic Minimed Infusion Sets Including Minimed Quick-set, Minimed Mio, Minimed Silhouette And Minimed Sure-t (specific Lots)

What are the defects? There have been recent reports of potential over-delivery of insulin shortly after an infusion set change. Subsequent investigations have found that this issue may be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol or water is spilled on the top of the reservoir or inside the tubing connector, which could prevent the insulin set from working properly. What should consumers do? Medtronic Australasia has written to consumers who have Medtronic MiniMed infusion sets to provide further information about this issue, include details of the recall procedure and instructions regarding the priming/fill-tubing process (called 'Key Steps'). If you or someone you provide care for uses Medtronic MiniMed infusion sets, go to (link is external) to determine if the infusion sets you have are affected by this recall. If you have affected infusion sets, follow the instructions on the website to arrange replacements. You will need to enter the REF and LOT numbers for all infusion sets you have. See the attached photographs of the box and pouch labels for the location of the REF and LOT numbers. Alternatively, you can call Medtronic on 1800 777 808 (press option 1). Unless you do not have access to a suitable alternative, do not use infusion sets that are affected by this recall. If you are unable to access infusion sets that are not affected by this recall, you can use the recalled products but must carefully follow the 'Key Steps' provided in the recall letter. This information is also available at (link is external). Alternatively, if you do not feel comfortable using these products, you can choose to revert to your back-up injection plan until your replace Continue reading >>

Urgent Recall - Medtronic Minimed Infusion Sets

Urgent Recall - Medtronic Minimed Infusion Sets

Medtronic, in consultation with the Therapeutic Goods Administrations (TGA), has issued a global recall of some infusion sets used with Medtronic insulin pumps. This recall was initiated following recent reports of the potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycaemia. To determine if you have any recalled infusion sets go to The website will prompt you to enter the REF and LOT numbers for all of the infusion sets in your possession. You will then be told which of the infusion sets are part of the recall, and which are not. The following link will tell you how to have any recalled infusion sets replaced by Medtronic. It also contains important safety information about avoiding potential insulin over-delivery: Please do not use any of the recalled infusion sets. If necessary, please make use of your diabetes self-management back-up plan as agreed with your health professional until Medtronic are able to replace your recalled products. Medtronic will replace any recalled sets free of charge. Medtronic has advised that replacement infusion sets are made with new and enhanced materials which reduce the risk of insulin over-delivery after an infusion set change. Diabetes Australia, as the administrator of the NDSS, will be directly writing to people who have purchased Medtronic infusion sets since July 2016. The National Diabetes Services Scheme (NDSS) is an initiative of the Australian Government administered with the assistance of Diabetes Australia. Continue reading >>

Medtronic Infusion Device Recall: No Reason To Panic

Medtronic Infusion Device Recall: No Reason To Panic

Medtronic Infusion Device Recall: No Reason to Panic Medtronic Infusion Device Recall: No Reason to Panic Last month, Medtronic announced a voluntary recall/replacement for many of their popular Paradigm infusion devices, including the Mio, Quick Set, and Silhouette. Interestingly, the problem is not with the tubing or the infusion set itself it is with the connector that attaches the tubing to the insulin reservoir. This piece, called a P-Cap, contains a vent that allows pressure within the reservoir to remain consistent with outside air pressure. If this vent become clogged, pressure within the reservoir can exceed outside air pressure, and can result in unintended movement of insulin out of the reservoir, through the tubing and infusion set, and into the users body. And we all know where that can lead. The potential for vent clogging has existed since Paradigm-compatible infusion devices were first developed. The problem came to a head with the advent of the 630G and 670G pumps, which are deemed water-tight by the manufacturer. With more people wearing their pumps in the water, the potential for clogging has increased but only if the P-Cap is not attached properly to the reservoir. When attached properly, the vents membrane is sealed from exposure to moisture, so clogs dont take place. If the P-Cap is attached improperly (i.e. at a bent angle to the reservoir), insulin can leak out and block the vent, and water from pump submersion can also block the vent. The incidence of reported problems related to the P-Cap has been very rare (1-2 per million infusion sets). Nevertheless, Medtronic redesigned the P-Cap to eliminate the problem and is offering to replace older infusion devices with new ones, free of charge. Does this mean that you should not use the older infusio Continue reading >>

Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets

Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles You are here: Home / Food Recalls / FDA Press Releases / Medtronic Announces Voluntary Recall of Diabetes Infusion Sets Medtronic Announces Voluntary Recall of Diabetes Infusion Sets Medtronic plc (NYSE:MDT) announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change. The company will work with patients to ensure recalled infusion sets with the discontinued component are returned and replaced with new infusion sets containing the updated component at no cost. Medtronic has contacted the U.S. Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this issue. Medtronic will continue working directly with government and regulatory authorities on this global voluntary recall. Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new Continue reading >>

Urgent Recall - Medtronic Minimed Infusion Sets

Urgent Recall - Medtronic Minimed Infusion Sets

Medtronic, in consultation with the Therapeutic Goods Administrations (TGA), has issued a global recall of some infusion sets used with Medtronic insulin pumps. This recall was initiated following recent reports of the potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycaemia. To determine if you have any recalled infusion sets go to The website will prompt you to enter the REF and LOT numbers for all of the infusion sets in your possession. You will then be told which of the infusion sets are included in the recall, and which are not. If you have any recalled infusion sets, please complete the online form. To ensure that your replacement request is processed, make sure you click the SUBMIT button once your form is complete. Once the online form is submitted, replacement box/es of infusion sets will be sent by Medtronic directly to your nominated delivery address, free of charge. Please cut-out and retain the barcodes on your recalled infusion set boxes. These should be placed in the reply-paid envelope that will be included in the delivery of the replacement infusion sets. Send this envelope back to Medtronic but do not return the recalled infusion sets. You can dispose of your recalled infusion sets once you have returned the barcode to Medtronic. The following link contains more information on the recall, including important safety information about avoiding potential insulin over-delivery: Please do not use any of the recalled infusion sets. If necessary, please make use of your diabetes self-management back-up plan as agreed with your health professional until Medtronic are able to replace your recalled products. Medtronic has advised that replacement infusion sets are made with new and enhanced materi Continue reading >>

Type 1 Diabetic Mom T1d (@mel7ofelfel) Instagram Photos And Videos

Type 1 Diabetic Mom T1d (@mel7ofelfel) Instagram Photos And Videos

Bio .2008 2011..I Am A Mother Of A Diabetic Child Type 1 Diabetic Mom T1D (@mel7ofelfel) Instagram photos and videos List of Instagram medias taken by Type 1 Diabetic Mom T1D (@mel7ofelfel) The University of British Columbia and Vancouver Coastal Health are testing a possible diabetes cure that replaces a persons damaged pancreatic cells with new ones grown in the lab.The replacement cells are grown from embryonic stem cells. Researchers believe that if the new cells mature, multiply, and behave as hoped, recipients would be able to lessen or even eliminate their dependence on self-injected insulin. They might also be spared from having to continually monitor their blood sugar, usually by pricking their fingers several times a day. The trial could involve about 10 or more people in Vancouver with a severe form of type 1 diabetes, in which a persons immune system attacks the pancreas, degrading or eliminating its ability to produce insulin.A UBC-Vancouver Coastal Health team, supported by a $500,000 grant from the Stem Cell Network of Canada, implanted the cells into one person in late December at Vancouver General Hospital, and they hope to do more implants in coming weeks. Participants will be followed for two years to see if the implanted cells mature into insulin-producing beta cells and other cells capable of controlling a persons blood sugar, and whether there are significant side effects.The implants are part of a larger clinical trial by San Diego-based ViaCyte, a biotechnology company that plans to test the cell-replacement therapy on approximately 40 patients in the U.S. and Canada.The implanted cells originally came from a single embryonic cell line, a type of cell capable of becoming any other type of cell in the body. ViaCyte has developed a technique for c Continue reading >>

Dh Notified Of Recall Of Specific Lots Of Minimed Infusion Sets

Dh Notified Of Recall Of Specific Lots Of Minimed Infusion Sets

DH notified of recall of specific lots of MiniMed Infusion Sets DH notified of recall of specific lots of MiniMed Infusion Sets *************************************************************** The Department of Health (DH) today (September 12) received notification from medical device manufacturer Medtronic Hong Kong Medical Limited (Medtronic) on its voluntary recall of specific lots of MiniMed Infusion Sets due to a potential safety concern. According to the information provided by Medtronic, the MiniMed Infusion Sets are used with Medtronic insulin pumps. Medtronic has recently received reports of potential over-delivery of insulin after changing of infusion set. The manufacturer's investigation revealed that the problem could be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on the top of the insulin reservoir which can then prevent the infusion set from working properly. The manufacturer said that new infusion sets currently being shipped contain an enhanced membrane material that can significantly reduce the risk concerned. While patients with new and enhanced infusion sets that are not part of the recall can continue to use their sets, those who are using the infusion sets being recalled should carefully follow the key steps regarding the priming/fill-tubing process as advised by the manufacturer before they can obtain new sets. "Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. We noted that the manufacturer has received relevant reports of hypoglycemia requiring medical intervention overseas. So far, the DH has not received any reports of adverse incidents related to the affected lots of infusion sets in Continue reading >>

Images About #medtronicrecall Tag On Instagram

Images About #medtronicrecall Tag On Instagram

The Webster Law Firm ( @thewebsterlawfirm2010 ) On February 27 2018 a recall was issued for Medtronics Defibrillators implanted between July 2013 to August 2017. If you or a loved one has a Medtronic defibrillator recall please contact The Webster Law Firm to speak to one of our attorneys.#thewebsterlawfirm#medtronicrecall #thewebsterlawfirm #medtronicrecall ReeRee T1Dlookslikeme ( @coolreeree ) So Im noticing the past few days my BGs have been running extremely low at times so Im thinking maybe its because Im using an infusion set from the recall list that I probably should have removed that set when I knew i was actually using one from a recall box. I did remove the boxes out of my good supplies but not the set I was using. I hadnt really noticed this even happening until now with who knows how many others Ive actually already used! #t1dproblems #lowbloodsugarproblems #medtronicrecall #infusionsets #yikes #medtronicaccuracy #medtronic670gcgm #t1dproblems #yikes #medtronicaccuracy #medtronicrecall #medtronic670gcgm #lowbloodsugarproblems #infusionsets 160+ infusion sets in my medicine cabinet on the recall! Scary! #medtronicrecall #checkyoursupplies #type1diabetes #type1diabetes #medtronicrecall #checkyoursupplies Medtronic Diabetes @medtronicdiabetes est haciendo un recall recogida voluntaria de sus sets de infusin a nivel mundial. Si eres usuario de bombas de infusion de insulina te interesa entrar a este link y revisar si tienes alguno de estos lotes //checklots.medtronicdiabetes.com/home #diabetes #medtronicrecall #revisatuslotes #diabetes #revisatuslotes #medtronicrecall **MEDTRONIC USERS** Medtronic is issuing a recall on some infusion sets. For more info call your customer support hotline. I believe they are replacing them but it takes some time so act sooner r Continue reading >>

Sou Doce: O Recall Da Medtronic

Sou Doce: O Recall Da Medtronic

A Medtronic anunciou emsetembro um recall em lotes especficos dos conjuntos de infuso da bomba deinsulina. Eu vi essa notcia no Facebook e no dei muita importncia no. Orecall era mundial. Em outubro, recebi 3 cartas daMedtronic informando sobre o recall e ento eu decidi verificar os lotes das 4caixas que eu tinha aqui em casa. Resultado: todas elas estavamno recall e precisam ser trocadas. Fiquei desesperada. Srio, meucho caiu e eu no sabia o que fazer. Como posto mensalmente aqui noblog, h muitos meses eu no recebo o conjunto de infuso da secretaria desade. Para compensar, eu acabo usando cada cateter por 4 ou 5 dias (eucoloco insulina no reservatrio para que dure por 4 dias, s vezes, eu utilizomenos insulina, consequentemente, o reservatrio acaba durando 5 dias. Mas esse o mximo de tempo que uso o mesmo cateter e quase nunca chega a durar 5dias). Assim, vou fazendo minha reserva de conjunto de infuso, uma vez que otratamento de alto custo e no consigo comprar os insumos que faltam todos osmeses. Que falta de sorte a minha emter 4 caixas reservas, no perodo em que eu no estou recebendo os insumos etodas as 4 estarem no recall. A primeira coisa que conseguipensar foi: vou comprar uma caixa e ir me virando com ela, at a Medtronictrocar as outras 4. Liguei no 0800 e quase choreiao telefone quando a atendente falou que a caixa com 10 unidades aumentou paraR$ 813,00!!! Fiquei sem fala. Comprei, a contragosto. O 0800 tem uma opo parafalar somente sobre o recall, a opo 4, que nunca atende. Ento eu apertoqualquer outro nmero (2 ou 3) e peo para me transferirem. Consegui, com muito custo,falar com algum sobre o recall. Me explicaram o seguinte: > Eu tinha 4 caixas fechadas e 1aberta, em uso, que estavam no lote do recall; >Dentro de 15 dias teis, apartir daquela ligao, a Medtr Continue reading >>

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