Following a July 2021 inspection, the US Food and Drug Administration (FDA) sent a December 9th warning to medical technology company Medtronic for lacking proper quality requirements at its Diabetes Business located in Northridge, CA.
The warning is related to the company’s recalled Minimed Insulin Pump.
The insulin pump and accessory devices were approved by the FDA in 2017 but were recalled for quality issues that led to approximately 2,000 injuries and 26,000 error reports.
Although the company says it is committed to improving its facilities and production, Medtronic suffered a 7% drop in stock price as a result of the news.
The 600 series MiniMed insulin pumps were recalled due to a missing or broken retainer ring, which helps to lock the insulin cartridge in place in the pump’s reservoir compartment, according to the FDA.
The recall affects all 630G (MMT-1715) models as well as all 670G (MMT-1780) models.
Based on research findings and adverse events reports, there are several injuries and complications associated with the MiniMed Insulin Pump that are not listed on the warning label.
These injuries and complications include hypoglycemia, seizures, diabetic coma, and even death.
The FDA classified the action as a Class I recall, the most serious kind of recall for medical devices, meaning that using the device could result in serious injuries or death.
MiniMed Pumps have a long history of defects and recalls over the last decade.
Prior Medtronic MiniMed insulin pump recalls date back as far as 2009.
Another Medtronic recall involved a remote controller for insulin pumps that contained potential cybersecurity risks - an unauthorized person could gain access to the remote control and either stop insulin delivery or over-deliver insulin to users.
TorHoerman Law was responsible for handling a medical case for our family. I was extremely impressed with their professionalism and ability to react quickly. They also did a nice job keeping us updated with the case throughout the process. This was the first time experiencing a situation like this and Tor Hoerman law did an excellent job from start to finish.
TorHoerman Law is an extraordinary law firm – a firm that truly makes the client’s best interests the primary concern. Their team of personal injury lawyers are experienced, personable, and well versed in a range of litigation areas. They are supported by a dedicated team of staff that are as equally friendly and helpful. I would recommend TorHoerman Law for any personal injury litigation needs.
All of my questions were answered quickly and in a way I could understand. Steve and the entire staff were friendly and professional.
I highly recommend this law firm! The attorneys and staff at THL worked hard, communicated every step of the process, kept me well informed at all times, and exceeded all expectations! The staff is kind, considerate, professional, and very experienced. Look no further, call now!
Top-notch, hardworking attorneys!
A wonderful and professional legal team. They helped me when I needed expert legal representation! Thank you TorHoerman Law!
They contacted me the next day. Very nice people!