Medtronic recalls MiniMed insulin infusion sets

July 24, 2013

FDA sent out a MedWatch warning, on July 12, 2013, after Medtronic recalled its MiniMed Paradigm insulin infusion sets.

FDA sent out a MedWatch warning, on July 12, 2013, after Medtronic recalled its MiniMed Paradigm insulin infusion sets.

Medtronic sent an Urgent Medicinal Device Safety Notification to all Paradigm insulin pump users and distributors to alert them that certain lots have the potential for over or under delivery of insulin. “If insulin or other fluids come in contact with the inside of the tubing connector, this can result in too much or too little insulin being delivered, resulting in hypoglycemia or hyperglycemia, which can be severe and lead to serious illness,” the MedWatch warning said.

The recalled products were manufactured from October 2001 through June 2013 and distributed from December 2001 through June 2013.

If patients notice anything unusual during the infusion set prime process, such as the insulin continuing to drip from the tip of the infusion set cannula when priming has been completed, this may indicate that the connector vents are not working properly, according to the FDA. “If this occurs, do not insert the infusion set and immediately call the HelpLine at 1 888-204-7616 for assistance,” the FDA stated.