Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets
Announcement 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 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 Medtronic Diabetes team will work as quickly as possib Continue reading >>
To All Lush Fans | Diabetes Uk
I had a call off my mil this morning who lives near lush in Poole dorset to tell me they are no longer taking orders online .... im worried now i ordered in November Thats crazy, strange place for hackers to target, I am sure they will be back up and running once they invest in some half decent security..... Yeah they aint guna let them ruin things.. I heard through a friend on FB that Lush were having hacker problems. I'm lucky we have a shop in town I love the stuff. I have a few bars tastefully placed around my bathroom, it makes the room smell edible.........yum...... Steffie - if you ordered in November you need to check with your bank for possible fraudulent use of your card. They are saying anyone who ordered online between 4 October and 20 January needs to check. Lots of people have been affected - hope you're not one of them.xx Steffie - if you ordered in November you need to check with your bank for possible fraudulent use of your card. They are saying anyone who ordered online between 4 October and 20 January needs to check. Lots of people have been affected - hope you're not one of them.xx Thanks I have , i knew we were ok before ringing as i check every morning the account and they was no sus activity, so phew for me anyways. Continue reading >>
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 >>
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Subject: Medtronic Diabetes Infusion Sets Recall Fillable
Subject: Medtronic Diabetes Infusion Sets Recall Fillable Important Information for Our Health Care Provider Partners DateOctober 122017 SubjectMedtronic Diabetes Infusion Sets Recall Medtronic PLCMedtronic the maker of diabetes infusion setshas issued a vol...Read More Important Information for Our Health Care Provider Partners DateOctober 122017 SubjectMedtronic Diabetes Infusion Sets Recall Medtronic PLCMedtronic the maker of diabetes infusion setshas issued a voluntary recall of specific lots of sets used with all models of Medtronic insulin pumps. The recall is related to the vent membranewhich was determined to be susceptible to blockage by fluid during the process of priming/fill tubing. The issue can potentially lead to over-delivery of insulinwhich may result in hypoglycemia. A list of your patients who may have been prescribed Medtronic diabetes infusion sets is printed on the reverse. Your patients can determine if they have recalled sets by visiting https //checklots.medtronicdiabetes. com and entering the REF and LOT numbers for all sets in their possessionthe REF and LOT numbers are listed on the labels as shown in the examples below . The website will advise which sets are recalled and which are not. Medtronic recommends not using recal Fill & Sign Online, Print, Email, Fax, or Download Continue reading >>
Product Recall: Medtronic Minimed Infusion Sets
Medtronic has announced a voluntary recall of their Medtronic MiniMed Infusion Sets. Why? There have been reports of over-delivery of insulin following infusion set changes. These occurrences of over-delivery of insulin can cause hypoglycemia, some cases being extreme and needing medical intervention. Medtronic states: 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. What You Can Do You can go to to see if you have recalled infusion sets. You’ll need to enter the REF and LOT numbers, which can be seen in this illustration, highlighted by the red boxes. Enter in the numbers for all of the infusion sets that you have to see if they are affected. Medtronic states not to use any of the infusion sets on the list. More Questions? Follow the process on the website at You can call Medtronic at 1.888.204.7616. You can also report an adverse event to the FDA’s MedWatch Adverse Event Reporting program: Report by telephone: 1.800.FDA.1088 Fax report: 1.800.FDA.0178 Continue reading >>
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Medtronic Issues Wide-ranging Infusion Set Recall
9/11/2017 – 12:30 pm (EST) – This story has been updated. On September 11th, Medtronic issued a notice stating that the company is voluntarily recalling certain lots of infusion sets used with all models of its insulin pumps. The recall covers all lots of Medtronic infusion sets sent to customers before April 2017, except for its infusion sets with luer locks during that time period; this exception was first reported by Diabetes Mine and has been confirmed by Medtronic. The recall also may affect some lots of infusion sets shipped after April 2017. A Medtronic press release states that the recall involves a discontinued component that has since been replaced in infusion sets currently being sold by Medtronic. Medtronic undertook the recall after field reports suggested that a vent membrane in the infusion set could become blocked by fluid during the priming and filling process. This can increase the risk for overdelivery of insulin during pump use, which could in turn increase the risk of hypoglycemia in the pump user, according to the press release. Currently, Medtronic has only received reports of this happening in one out of every 2 million infusion sets in use, but that ratio very well might go up somewhat as news of the recall spreads. sponsor Medtronic reports that it has developed a membrane design update which the company believes will reduce the risk of overdelivery of insulin after a set change. This update was phased into infusion set lots shipped after April 2017. The company states it will replace infusion sets covered by the recall free of charge, and it discourages customers from using infusion sets from lots listed in the recall. In the FAQ section about the recall, the company states users should consider using multiple daily injections while waitin Continue reading >>
Dh Notified Of Recall Of Specific Lots Of Minimed Infusion Sets
DH notified of recall of specific lots of MiniMed Infusion Sets Hong Kong (HKSAR) - 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 Hong Kong," a spokesman for the DH said. Patients using the affected devices should visit the manufacturer's Continue reading >>
Home | Medtronic Diabetes Checklots
Medtronic has recently observed a new trend in customer reports related to potential over-delivery of insulin shortly after an infusion set change. Because the safety of our customers is our top priority, we are voluntarily recalling specific lots of infusion sets used with Medtronic insulin pumps - in cooperation with regulatory agencies. We designed this website to make it easy for you to quickly check which of your infusion sets are recalled and which are new and enhanced. Just follow the 3 simple steps below so we can prepare to send you free replacements. 3. Check your MiniMed infusion set REF number and LOT number to see if you have recalled product. The REF number and LOT number on your infusion set can be located on the box and pouch labels. If the reference number (REF) on your box or pouch label has more than 3 digits after MMT, please just enter the first 3 digits as they appear. See example above. When entering QUANTITY below, please indicate the number of individual infusion set pouches you have on hand (eg. If you have one full 10-count box and four individual pouches, please enter "14"). Please enter the REF number, LOT number, and QUANTITY of individual infusion sets you have. Continue reading >>
Medtronic Recalls Specific Lots Of Diabetes Infusion Sets
(RTTNews) - Medtronic plc (MDT) announced a voluntary recall of specific lots of infusion sets used with all models of its insulin pumps related to a certain discontinued component in these infusion sets. The company noted that a component, the vent membrane, may be susceptible to being blocked by fluid during the process of priming/fill-tubing, which can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. Medtronic said will continue working directly with government and regulatory authorities on this global voluntary recall. Francine Kaufman, chief medical officer of the Diabetes Group at Medtronic, said, "Our Medtronic Diabetes team will work as quickly as possible to complete all exchanges to the new and enhanced set and fully support our customers throughout this process." Medtronic expects this recall of infusion sets not to impact Diabetes Group revenue growth in the second quarter or the full fiscal year. The company has provided the website to determine which REF and LOT numbers of the infusion sets are part of this recall. Continue reading >>
Safety Alerts | Medtronic-diabetes.in
Notification Letter - Medtronic MiniMed Infusion Sets (ARTG 119216) Because the safety of our customers is our top priority, Medtronic, in consultation with the Therapeutic Goods Administration (TGA) and Medsafe, is initiating a recall for specific Lot Numbers of infusion sets used with Medtronic insulin pumps (TGA Recall Identification # RC-2017-RN-01182-1) and Medsafe Reference # 21954). 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 hypoglycaemia and in extreme cases, death. Medtronic has received reports of hypoglycaemia requiring medical intervention potentially related to this issue. Out of the millions of infusion sets sold each year, the reported incident rate requiring medical assistance related to this issue is less than 0.00005%. There have been no reports of death related to this matter. Our investigation has shown this issue 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 the top of the reservoir or inside the tubing connector 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. A. 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. Please follow the instructions on the website. B. Please do not use recalled infusion sets. If you have new and enhanced in Continue reading >>
