FDA Recalls Insulin Administration Models

FDA Recalls Insulin Administration Models



The U.S. Food and Drug Administration has initiated the recall of the Medtronic MiniMed Paradigm Quick-set Plus infusion sets, models: MMT-359S6, MMT-359S9, MMT-359L6, and MMT 359L9.

The device is an insulin administration set. Complaints have been made of bent cannulas, occlusions within the tubing, leaking at the insertion site, and accidental dislodging of the infusion set while removing the insertion device. Adhesive failure, causing the device to fall off the skin and interrupt insulin flow to patients, also has been reported, according to the FDA.

This is a Class 1 recall, the most serious type of recall, suggesting reasonable probability that use of the product will cause serious injury or death. Patients should discontinue use of the Paradigm Quick-set Plus infusion sets as soon as they get replacement units. Medtronic MiniMed, the company that makes the devices, is providing free replacements by overnight delivery. Patients should call the 24-hour help line (option 1) at (800) 646-4633 or contact the firm at www.minimed.com/QSP.