Medtronic Expands MiniMed Insulin Pump Recall

Related to the 2019 recall involving nearly 500,000 devices, the FDA has put out an expanded recall on even more Medtronic products. This new, expanded recall encompasses more than half of the devices the company has already replaced or upgraded for customers.

The Class I recall, the most serious type of recall the FDA can issue, states that the pumps may deliver the incorrect dosage level of insulin for users. The retainer ring has been previously identified as an issue in models 630G and 670C and Medtronic has gone forward with replacements and upgrades for customers, but now the recall involves all model 600 types. 

Medtronic provided the following advice for customers who may have a faulty insulin pump:

• Determine if you have a clear retainer ring. That can be done by going to a Medtronic website and entering the serial number of your pump.
• Examine the retainer ring of the pump. If the ring is loose, damaged or missing, or the reservoir does not lock into the pump, stop using the pump and contact Medtronic for a replacement pump.
• If you stop using the pump, follow your doctor’s recommendations and perform manual insulin injections. Do not insert the reservoir back into your pump while connected because you could mistakenly give yourself a rapid, and possibly large, insulin dose.
• If the reservoir locks in place correctly and the retainer ring is not loose, damaged or broken, continue to use the pump until you receive a replacement pump. Follow instructions provided by Medtronic to replace and use the pump.
• Check your pump and retainer ring for damage every time you replace the insulin reservoir, or when it is dropped or bumped.

Medtronic also recalled MiniMed model MMT-500 and MMT-503 remote controllers for insulin pumps; the FDA says customers should halt use of these products. The remote controllers are recalled due to a cybersecurity risk that would allow an unauthorized person to control the pump’s dosage levels or stop delivery. 

Medtronic MiniMed insulin pump lawsuits are currently being filed on behalf of individuals who have suffered injury as a result of the defect insulin pumps.