The FDA today announced that Medtronic (NYSE:MDT) has expanded the Class I recall of its MiniMed 600 series insulin pumps.
Medtronic today notified customers by email and phone that the recall has been expanded to replace all MiniMed 600 series insulin pumps that contain the clear container ring.
The Fridley, Minnesota-based company first warned of safety problems with the pumps in November 2019. The recall initially involved 322,005 MiniMed 630G and MiniMed 670G pumps in the U.S.
FDA confirmed that the recall covers MiniMed Model 630G pumps distributed between September 2016 and February 2020, as well as MiniMed Model 670G pumps distributed between May 2015 and December 2020. In total, 463,464 devices have now been recalled in the U.S.
Serious injuries and deaths have been reported with the use of MiniMed 600 series insulin pumps, but those events may not have been directly related to the damaged clear retainer rings that constitute the basis of this particular recall, the FDA said.
Medtronic is recalling the affected pumps to replace any pump that has a clear retainer ring with one that has an updated black retainer ring at no charge, even if the clear retainer ring is not damaged and regardless of warranty status. Medtronic previously identified and informed customers about missing or broken clear retainer rings in the pumps.
MiniMed’s retainer ring helps to lock the insulin cartridge into place in the pump’s reservoir compartment. If the cartridge is not firmly locked, under- or over-delivery of insulin may occur, which could cause low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia), both of which can be life-threatening.
Medtronic issued a statement saying that the review of safety data related to the MiniMed 600 series insulin pumps with clear retainer rings has not confirmed that adverse events were directly related to the damaged clear retainer rings, but that the company is “proactively accelerating our replacement plan so we can strive for the greatest possible reliability and quality in our insulin pumps and help patients optimally manage their diabetes.”
“Insulin pumps are sophisticated medical technologies that work to normalize blood glucose levels as much as possible in individuals with diabetes who don’t have the ability to produce insulin naturally,” Medtronic Diabetes CMO Dr. Robert Vigersky said in the news release. “As with all therapies, there are risks that should be considered when a patient and their healthcare provider decide to use a pump for insulin delivery rather than multiple daily injections. The totality of evidence from both controlled, large scale clinical trials and real-world studies strongly support the safety and benefits of insulin pump therapies.”