Medtronic Insulin Pump Infusion Sets Recalled

Medtronic has again voluntarily recalled specific lots of its infusion sets, available to patients since April 2017, used with Medtronic insulin pumps.  A component, the vent membrane, in the infusion set is defective. The defective vent membrane  is susceptible to being blocked by insulin during the priming or filling the tubing process. This can lead to a potential over-delivery of insulin, which can cause hypoglycemia, low blood sugar.
Medtronic has stated that they will replace the defective infusion sets with new infusion sets without the defective component.

What to Do

Patients can determine if they have recalled infusion sets by clicking here.
For a copy of the U.S. recall notification letter, click here.
If you have experienced an issue with the use of a Medtronic infusion set, please report it to the Food and Drug Administration (“FDA”) 24-hour helpline at +1-800-204-7616. Patients can also report adverse events to the FDA’s MedWatch Adverse Event Reporting program:

  • Online here
  • Report by telephone: +1-800-FDA-1088

Fax report: +1-800-FDA-0178

About The Author

Leslie A. Goller

Leslie A. Goller

Leslie has dedicated her career to championing consumers – whether they were harmed by big corporations, dangerous products, medical mistakes, accidents, or an unsafe environment – no issue is too big for her to tackle. She successfully prevented an incinerator from being built at University Hospital (now UF-Jacksonville), which would have polluted the air with toxic chemicals and obtained significant restrictions of other Jacksonville hospital incinerators resulting in cleaner air.