according to a Food and Drug Administration MedWatch release.
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A class I recall such as this indicates that there is reasonable probability that using a defective pump will cause serious adverse health consequences or death, the agency said in the recall notice. It said the company has received more than 26,000 complaints regarding this problem and is aware of 2,175 injuries and 1 death so far. In all, 322,005 devices have been recalled.
If the pumps in question – Model 630G (distributed September 2016 to October 2019) and 670G (June 2017 to August 2019) – have broken or missing retainer rings, the insulin cartridge can end up loose in the reservoir compartment, which can lead to incorrect dosing and therefore potentially to hyperglycemia or hypoglycemia, according to the statement.
Model 630G was approved by the FDA in August 2016, and the 670G in September that same year.
On Nov. 21, 2019, Medtronic advised patients with type 1 diabetes who use the pumps to:
- Examine the retainer ring to see if it is loose, broken, or missing.
- Stop using the pump if the reservoir does not lock correctly or if the retainer ring is loose, damaged, or missing. Patients should contact Medtronic for a replacement pump and follow their doctor’s recommendations and perform manual insulin injections.
- Continue using the pump if the reservoir locks in place correctly.
- Check pump and retainer ring if the pump is dropped by accident, and stop use if it is damaged.
- Check the pump and retainer ring every set change to verify the reservoir is locked correctly.
More information regarding this recall, including how to contact Medtronic Technical Support, can be found on the FDA website.