Medtronic recalls insulin infusion pumps

July 13, 2009 - 0 comments

Washington -- The U.S. Food and Drug Administration announced the recall of some lots of Quick-set infusion sets produced by Medtronic Inc. for use by diabetes patients.

The FDA said the infusion sets are used with the company's MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days, officials said.

Medtronic said the recalled infusion sets have reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 and with lot numbers starting with the number "8."

Medtronic recently discovered approximately 60,000 of the infusion sets might fail to allow the insulin pump to vent air pressure. That, officials said, could potentially result in the device delivering too much or too little insulin and could lead to serious injury or death.

The company said the lot number is marked on both the product box label and on each individual infusion set package.

Customers are being asked to return any affected infusion sets to the company, which will provide replacement Quick-set infusion sets at no additional charge.

"Lot 8" Quick-set infusion sets were distributed in the United States, and
well as in other nations, including the Bahamas, Bermuda, Brazil, Canada, Ecuador, El Salvador, Germany, Kuwait, Mexico, Paraguay, Turkey and the United Kingdom.

More information is available at www.medtronicdiabetes.com/lot8.