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More than 800 complaints weren't investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter. In November 2019, Medtronic, citing the ring problem, launched an ' urgent medical device recall' of the pumps, which it expanded in late 2021.ĭuring 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.

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The pump was tested on 123 patients in a clinical trial over several months with 'no serious adverse events,' the release said.

In a news release that day, Jeffrey Shuren, who directs the FDA's Center for Devices and Radiological Health, lauded the device as a 'first-of-its-kind technology' that would give patients 'greater freedom to live their lives' and to monitor and dispense insulin as needed. 28, 2016, after its most stringent safety review, a little-used process known as premarket approval. The FDA approved the MiniMed 670G insulin pump on Sept. In a statement to KFF Health News, the FDA said it 'has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices.' 'Too little, too late' Instead, manufacturers must simply show they have 'substantial equivalence' to a product already in the marketplace - an approval process some experts view as vastly overused and fraught with risks.Īnd once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuries - while injured patients face legal barriers trying to hold manufacturers accountable for product defects. The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness.

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CBS News co-reported and aired TV stories about the hip and dental devices. And even a dental device, used on patients without FDA review, that lawsuits alleged has caused catastrophic harm to teeth and jawbones.Last-resort heart pumps that FDA records state may have caused or contributed to thousands of patient deaths.Metal hip implants that snapped in two inside patients who said in lawsuits that they required urgent surgery.Artificial knees manufactured by a Gainesville, Florida, company that remained on the market for more than 15 years despite packaging issues that the company said could have caused more than 140,000 of the implants to wear out prematurely.Over the past year, KFF Health News has investigated medical device malfunctions including: The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could 'lead to an over or under delivery of insulin,' which could 'be life threatening or may result in death.'Īs the recall played out, federal regulators discovered that Medtronic had delayed acting - and warning patients of possible hazards with the pumps - despite amassing tens of thousands of complaints about the rings, government records show. The company has denied the pump caused the man's death and is seeking to dismiss the case. Daughter Carla Wiggins (left) is fighting the device company in court in Florida.

His family alleges in a lawsuit that the Medtronic MiniMed insulin pump he relied on malfunctioned and killed him from an overdose of insulin. Carlton 'PeeWee' Gautney Jr., a dispatcher with the police department in Opp, Alabama, died at age 59 in May 2020.

The wrongful-death lawsuit alleges the pump was 'defective and unreasonably dangerous.' Medtronic has denied the pump caused Gautney's death and filed a court motion for summary judgment, which is pending. 'There's a big hole left where he was,' said Gautney's daughter, Carla Wiggins, who is suing the manufacturer.