Irish medical technology company Medtronic plc is recalling certain MiniMed insulin pumps for Type 1 diabetes after incorrect insulin dosing by the device caused thousands of injuries and one death, the US Food and Drug Administration announced.
In a statement, the health regulator identified this as a Class I recall, the most serious type of recall, and warned that the use of these devices may cause serious injuries or death.
The recall affects around 322,005 units of MiniMed 600 Series Insulin Pumps, comprising Model 630Gs and Model 670Gs. All lots of Model 630G (MMT-1715) before October 2019 and all lots of Model 670G (MMT-1780) before August 2019 are affected in the recall. Model 630G were distributed from September 2016 to October 2019, while Model 670G were distributed from June 2017 to August 2019.
The Model 630G insulin pumps are meant for persons of sixteen years of age and older, while Model 670Gs are for persons of fourteen years of age and older.
According to the FDA, the recall was initiated due to a missing or broken retainer ring that helps to lock the insulin cartridge into place in the pump’s reservoir compartment. Not locking the cartridge firmly into place may result in under or over delivery of insulin that could cause hypoglycemia or hyperglycemia. Severe hyperglycemia can result in a loss of consciousness, seizure, and death.
The company reported 2,175 injuries and 1 death due to the device’s malfunctioning. In total, the company has received 26,421 complaints.
Medtronic, which generates most of its sales from the U.S., on November 21 last year had notified the affected customers, asking them to examine their pump for a broken or missing retainer ring, and to contact the firm for a replacement if any issues.
In June last year, Medtronic had recalled MiniMed 508 Insulin Pump and MiniMed Paradigm Series Insulin Pumps for fear of hacking. The FDA then warned that these insulin pumps, which were designed to communicate using a wireless radio frequency with other devices, hold potential cyber security risks.
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