Medtronic Insulin Pumps Recalled After 1 Killed, Thousands Injured From Incorrect Doses

Medtronic withdraws 300K insulin pumps after death 2K lesions- WCCO

Medtronic withdraws 300K insulin pumps after death 2K lesions- WCCO

The FDA announced an worldwide Class 1 recall of 322,005 Medtronic's MiniMed 600 Series Insulin Pumps that can cause the user to receive an incorrect amount of insulin. Besides people with diabetes who use the pump, this may affect health care providers who treat people with diabetes using this pump.

If the cartridge is not locked firmly into place, patients could receive either too much or too little insulin. Customers should stop using the device if the reservoir does not lock into the pump or if the retainer ring is loose, damaged or missing, according to the FDA. Hypoglycemia or hyperglycemia can occur in these instances. The FDA has identified this as a Class I recall, the most serious type of recall.

According to the recall notice, Medtronic has heard 26,421 complaints, 2,175 injuries and one death.

The Food and Drug Administration announced the recall Wednesday, but Medtronic began communicating with customers in November. "Severe hyperglycemia can result in a loss of consciousness, seizure, and death".

The pumps might have a missing or broken retainer ring.

If you or anyone you know is still using the recalled Medtronic MiniMed insulin pump, the company asks they call 24-hour Medtronic Technical Support at 877-585-0166.

In an FAQ for the safety notification sent out for the products, Medtronic noted that this recall does not apply to the MiniMed Paradigm insulin pumps.

Customers can contact Medtronic for a replacement pump.

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