Medtronic Recalls Specific Lots of Paradigm Quick-Set Infusion Sets

Medtronic, Inc., has initiated a recall of specific lots of Quick-set infusion sets that are used with 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 3 days.

Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8.” Medtronic recently discovered that approximately 2 percent of “Lot 8” Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly.

The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death.

"Lot 8” Quick-set infusion sets were distributed in the United States, and in limited quantities in a small number of countries outside of the United States.

JULY-13-09: Paste Heading or write precis from source article here [FDA: MEDTRONIC ISSUES RECALL OF LOT 8 QUICK-SET INFUSION SETS]

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