Medtronic recalls diabetes devices

Posted on Jul 31, 2009 in Health & Wellness

Minneapolis / St. Paul Business Journal – by Chris Newmarker Staff Writer

Medtronic Inc. on Friday said it has initiated a recall of infusion sets – thin tubes that deliver insulin from insulin pumps to diabetes patients – because the tubes may not deliver insulin properly.

Fridley-based Medtronic (NYSE:MDT) said the Quick-set infusion sets may not allow insulin pumps to properly vent air pressure, and that could result in diabetics getting too much or too little insulin, a situation that could cause serious injury or death.

About 60,000 of the estimated 3 million infusion sets presently with customers are affected.

The affected infusion sets, sold mostly in the U.S., have reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8.” Customers with those sets are being told to stop using “Lot 8” sets.

Customers are being asked to return any affected infusion sets to the company. Medtronic is providing customers with replacement Quick-set infusion sets at no additional charge.

“We are working closely with the FDA, and our goal is to make this product exchange as timely and as easy as possible for patients,” said Chris O’Connell, president of Medtronic’s diabetes business unit and a senior vice president at the company.

 

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