Medtronic has recently notified the public that it received a warning letter from the FDA over quality control concerns at its diabetes unit. Included within that letter were issues related to the corporation’s risk assessment, its propensity for device recalls, and the way it handles complaints that are brought to its attention. News of the letter sent Medtronic’s stock price down to some of its lowest points in over a year.
The letter was related to an earlier discovery of a fault with Medtronic’s MiniMed insulin pump that led to a Class I recall earlier this year. The Class I recall is among the FDA’s most urgent actions and is reserved for products whose continued use “may cause serious injuries or death.” In fact, at least one death has been tied to the MiniMed issue, as well as over 2,100 reported injuries.
Over 26,000 reports of device failure had been filed when a critical retainer ring in the MiniMed was found to be failing. This failure caused the pump to either over- or under-deliver insulin to the diabetic patient wearing the device and, in some cases, ended with predictably catastrophic results.
To say that Medtronic is familiar with recalls is a bit like saying that Webster’s is familiar with the English language. An entire line of its heart pumps had to be pulled from the market and it also saw a recall of its Rashkind balloon septostomy heart catheter. In fact, one of Medtronic’s pre-market products – which is to say a product that is not even publicly available yet – has had such a string of failures that the FDA has already issued warnings about it over “major complications related to cardiac perforation.”
The federal regulator’s latest letter is certain to go on top of an already significant stack of warnings accrued by the company as it works to try to pull itself out of the crosshairs for 2022.
