The U.S. FDA has designated a recall of hundreds of thousands of Medtronic Minimed insulin pumps as Class I — the most serious type of recall.
Medtronic (NYSE:MDT) first warned of safety problems with the pumps in November. The recall involves 322,005 pumps — MiniMed 630G (model MMT-1715) and MiniMed 670G (model MMT-1780) — in the U.S., FDA said today.
The problem stems from a missing or broken retainer ring, meant to lock the insulin cartridge into place in the pump’s reservoir compartment. If the cartridge is not locked firmly in place an underdose of an overdose of insulin might occur — a potentially deadly situation. Medtronic has received 26,421 complaints about the malfunction — with reports of a person potentially dying because of the problem, as well as 2,175 injuries.