One of the largest manufacturers of medical devices is recalling two of its popular insulin pumps. Medtronic (NYSE:MDT) issued a recall through the Food and Drug Administration for its MiniMed 630G and MiniMed 670G pumps on Wednesday, advising patients to inspect their devices and contact the company for a replacement pump if their pump's retaining ring is loose, broken, or missing. The recall affects 322,005 devices manufactured and distributed prior to October 2019.
The retaining ring is responsible for locking the insulin reservoir to the insulin pump. The company has received 26,421 complaints that retaining rings on the MiniMed 630G and MiniMed 670G can malfunction, potentially resulting in life threatening over- or under-delivery of insulin. Medtronic says it's aware of 2,175 injuries and 1 death associated with this issue.
Patients are instructed to regularly inspect the retaining ring for problems. If they notice one, they are advised to "discontinue using the insulin pump and revert to a back-up plan of manual insulin injections per your doctor's recommendations." The company also says patients should not "insert the reservoir back into your pump while connected because you could mistakenly give yourself a large insulin bolus."
Patients can request their replacement pumps by filling out a form online or calling Medtronic at (877) 585-0166.
In November, Medtronic reported strong sales of the MiniMed 670G were driving double-digit percentage growth in insulin pump sales and double-digit revenue growth in related supplies. That helped lift sales in its diabetes segment during its fiscal Q2 by 4.3% year over year to $596 million.