Medical devices are killing the patient, and the FDA can do little about it.

Deep flaws in FDA oversight of medical devices, and patient harm, exposed in lawsuits and records • Minnesota Reformer

"During an inspection at Medtronic’s plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall. More than 800 complaints weren’t investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter."

… “not intended to evaluate the safety and effectiveness of medical devices”