FDA Issues Update on Medtronic’s Insulin Pump Recall

The FDA released further details on Medtronic’s Class I recall of certain MiniMed 600 insulin pumps. The company issued the initial recall in November 2019 after receiving thousands of complaints and injury reports for the devices.

The recalled devices — Model 630G units distributed between September 2016 and October 2019 and 670G units distributed between June 2017 and August 2019 — have missing or broken retainer ring pieces that hold the insulin cartridge in place in the pump’s reservoir compartment.

“If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia,” the FDA said.