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