UNITED STATES – As reported online by www.startribune.com, the FDA has issued a Class II recall of Medtronic MiniMed 600-series insulin pumps amid concerns that the buttons on the devices may become stuck while flying or in other circumstances where there is a quick change in air pressure.
Medtronic, a medical device manufacturer, has recalled multiple brands and models of its insulin pumps. Medtronic’s MiniMed 508 and Paradigm insulin pumps are currently subject to a Class I recall for cybersecurity vulnerabilities that may impact patient safety. A Class I recall is issued when the use of a medical device has the potential to cause serious injuries or death to patients.
Medtronic’s MiniMed 600-series insulin pumps do not share the same heightened safety concerns as the 508 and Paradigm models, but the 600-series insulin pumps still have defects/problems that need to be addressed. As such, the FDA has classified the recall as Class II, which, while serious, does not pose the same risks to patients as medical devices subject to Class I recalls.
More than 189,000 MiniMed 600-series insulin pumps are included in the FDA’s Class II recall notification. The recall encompasses the following MiniMed insulin pump models:
- MiniMed 620G;
- MiniMed 630G;
- MiniMed 640G; and
- MiniMed 670G.
Each of these models has physical keypad buttons which may become temporarily unresponsive with a fast change in pressure, which typically happens during takeoff and landing on a flight. However, other situations which result in quick pressure change can have the same effect on the MiniMed 600-series insulin pumps. Medtronic asserts that the problem eventually resolves on its own, but that software changes are needed to address the issue.
The problem with the keypad buttons was first reported in 2017, and the FDA was going to review the problem and take appropriate action. The FDA, after two years, issued the Class II recall. Given that the defect identified in the MiniMed 600-series insulin pumps do not pose a serious risk of injury or death to patients, affected patients are not required to return the insulin pumps.
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