Drug Safety Alerts

Medtronic Infusion Sets Consumer-Level Recall

9/25/2017

On September 25, 2017, Medtronic issued a consumer-level recall of various infusion sets. This recall was issued because 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 the potential for 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.

Medtronic recommends that customers use only infusion sets made with the new and enhanced component, the membrane, starting with their next set change.

CVS Caremark Response: Because of this action, CVS Caremark is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using affected infusion sets to contact their prescriber.

For a list of potentially impacted products, please click here:

For more information about this, recall, health care providers may visit https://www.medtronicdiabetes.com/notice7 or call Medtronic toll-free at 1-888-204-7616.

You may also contact the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.