Medtronic Insulin Pump Recall

 

 

Medtronic Inc. has voluntarily recalled lots of Quick-set infusion sets used with MiniMed Paradigm insulin pumps. Infusion sets are plastic tubes that deliver insulin from the insulin pump to patients with diabetes. The infusion set is replaced every few days. Metronic reports that infusion sets beginning with Lot number “8″ may not work correctly.

Although the company says this recall only affects around two percent of the nearly three million infusion sets, Medtronic has asked that all patients using them to return them. A replacement Quick-set infusion set will be provided free of charge.

Medtronic says the affected infusion sets may keep the insulin pump from venting air pressure properly. This may cause too much or too little insulin to be delivered, causing injury or death.

The affected infusion set reference numbers include:

  • MMT-396
  • MMT-397
  • MMT-398
  • MMT-399

The lot number (8XXXXXX) is marked on the box label and on the infusion set label. These were distributed throughout the U.S. and in limited quantities to diabetics in the following countries:

  • Bahamas
  • Bermuda
  • Brazil
  • Canada
  • Ecuador
  • El Salvador
  • Germany
  • Kuwait
  • Mexico
  • Paraguay
  • Turkey
  • United Kingdom

If you are in possession of one of Medtronic Inc.’s Quick-set infusion sets from Lot 8, stop using it immediately and contact Medtronic to receive new ones.