Medtronic recalls insulin infusion equipment

The potential malfunction could lead to serious injury, even death.

By JANET MOORE, Star Tribune

Last update: July 10, 2009 - 11:42 PM

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Medtronic Inc. said Friday it has voluntarily recalled a product used by diabetes patients in conjunction with insulin pumps because it may not work properly. No injuries have been associated with the potential malfunction.

The Fridley-based company recalled lots of its Quick-set infusion sets that are used with its MiniMed Paradigm insulin pumps. An infusion set, a thin plastic tube that delivers insulin from the pump to the patient, is replaced every three days.

The affected infusion sets have the reference numbers MMT-396, MMT-397, MMT-398 and MMT-399, with lot numbers that begin with 8.

Medtronic said it recently discovered that 2 percent of the products, or 60,000 sets out of an estimated 3 million currently with customers, may not work properly.

The affected infusion sets may result in the device delivering too much or too little insulin, which could lead to serious injury, even death.

Medtronic said patients should discontinue using the Lot 8 Quick-set infusion sets and return them to the company. The lot number is clearly marked on the product box label and on each infusion set package. Patients with questions about the recall can get more information at www.med tronicdiabetes.com/lot8.

The company said it will provide customers with replacement infusion sets at no charge.

Janet Moore • 612-673-7752

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