Medtronic Issues Global Voluntary Recall of Certain Pump Infusion Sets

By Jeemin Kwon and Adam Brown

Recall applies to sets manufactured before April 2017; Medtronic is replacing old sets that have a risk of insulin over-delivery

Medtronic is voluntarily recalling specific lots of pump infusion sets manufactured before April 2017 as a result of reports of over-delivery of insulin following an infusion set change – check if your sets are affected here (US) and here (outside the US). Medtronic will replace your sets at no cost if they are part of the recall. If your sets were manufactured after April 2017, they are likely not affected, but it is safest to use the sites above to look them up.

What’s the problem? The recall concerns a part of the infusion set called the “vent membrane,” which is inside the cap that connects the top of the reservoir to the set tubing. Medtronic has determined that if insulin, alcohol, or water is spilled on top of the insulin reservoir during the priming/fill-tubing process, the “vent membrane” can get wet and prevent the set from functioning properly. This can lead to over-delivery of insulin. We imagine this might happen if someone had wet hands or was changing a set in wet conditions. Sets manufactured after April 2017 contain an improved membrane that addresses the issue.

Is the risk high? No. Medtronic estimates fewer than one event occurs for every two million infusion sets. Based on data reported from June 2016-August 2017, the company identified 28 reports of hypoglycemia (low blood sugar) shortly following an infusion set change. These episodes involved “medical intervention,” meaning some were serious and some presumably required assistance from a third person. Though the overall rate of occurrence was low, the incidents were still meaningful. This recall is being issued for safety, since over-delivery of insulin can cause hypoglycemia.

What if I’m already wearing an older set? If a recalled infusion set is already in use for a few hours or days, it does not need to be removed earlier than it otherwise would be – the problem arises during the infusion set fill/priming process. If you have a current supply order, do not cancel it, as all infusion sets received moving forward will have the fixed issue.

Quick Information for Medtronic Pump Users:

• US users – check if your sets are recalled here

• Outside the US users – check if you sets are recalled here

• To return recalled infusion sets, see instructions on this page

• If you only have recalled sets, follow the tips on this page to minimize risk of insulin over-delivery while waiting for your new sets to arrive

The FDA and other regulatory bodies have been notified about the issue, and Medtronic is working to make sure that all pump users have the newer infusion sets made after April 2017. For additional questions, see the FAQs on the right side of this page, or contact Medtronic at 1-888-204-7616.