FDA Classifies Medtronic Insulin Pump Recall As Class I

Update Appended FDA has identified a recent recall of Medtronic insulin pumps as a class I recall, the most serious category of device recalls reserved for products that can result in serious injury or death. Medtronic originally recalled its MiniMed 600 series insulin pump in November 2019 due to missing or broken retainer rings that, according to Medtronic, could result in inaccurate insulin delivery dosage and may cause hypoglycemia or hyperglycemia. In an urgent field safety notification,...