FDA says Medtronic MiniMed insulin pump recall is serious

February 12, 2020 By Chris Newmarker Leave a Comment

Medtronic’s MiniMed 630G insulin pump [Image courtesy of Medtronic]

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 number is 481,875 worldwide.

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 or 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.

Retainer ring problems were apparently the result of pumps not designed to properly withstand accidental blows. Medtronic spokesperson Pamela Reese told MassDevice in an emailed statement that the suppliers making the retainer rings delivered parts that met Medtronic’s specifications.

“Based on our analysis of damaged retainer rings from past insulin pumps, we made improvements to the pump design to better withstand the accidental drop or bumping of the pump on a hard surface,” Reese said. “To help address this potential issue and as part of our ongoing quality efforts, we have made improvements to the pump retainer ring. In October 2019, we began switching pump production to contain the reinforced retainer ring to better withstand the accidental dropping of a pump.”

Affected pumps include MiniMed 630G (model MMT-1715) pumps made before October 2019 and distributed from September 2016 to October 2019, as well as MiniMed 670G (model MMT-1780) pumps made before August 2019 and distributed from June 2017 to August 2019.

Medtronic said it has notified people using the pumps, advising them to inspect the retainer ring and make sure the reservoir properly locks into the pump. The urgent field safety notice told pump users to discontinue use if the reservoir does not lock into the pump or the retainer ring is loose, damaged or missing.

People can continue using pumps that are working properly.

The medical device giant designed the MiniMed 670G system to automatically track and adjust a patient’s blood sugar levels by measuring blood glucose every few minutes and automating the dosing of insulin. The automated insulin delivery system first won FDA approval in September 2016 — touted at the time as an important step toward the goal of creating a so-called “artificial pancreas” insulin pump system. The FDA approved the MiniMed 630G in 2017.

MDT shares were down 1.55%, to $117.11 apiece, in midday trading today.

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