FDA Issues Update on Medtronic Insulin Pump Recall
The FDA has issued an update on Medtronic’s Nov. 29, 2019, recall of its MiniMed 600 series insulin pumps, which the agency identified as a Class I recall because the devices may cause serious injury or death.
The recall was prompted by the risk of a missing or broken retainer ring in some of the pumps that help to lock the insulin cartridge in place. If not locked firmly into place, the patient could receive too little or too much insulin.
The agency noted that Medtronic will replace any MiniMed 600 series insulin pump that has a clear retainer ring with a pump that has the updated black retainer ring at no charge.
A replacement insulin pump will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump, the agency said.