With medical devices, recalls are not always what they seem. In some recalls, including some of the most serious, the FDA and the manufacturers let doctors and hospitals continue to use the devices.

More than 10 million medical devices were recalled in 2020, according to the Food and Drug Administration1. All medical devices carry some risks, and sometimes either the FDA or the device ...

The FDA has designated Cook Medical's recall of its Beacon Tip 5.0 Fr angiographic catheter as Class I, the most serious ...

The FDA is amplifying a recall from Medtronic for its acid reflux testing system, after the company said it received 33 ...

A recent study identified 157 cardiovascular devices recalled from 2013 to 2022. Recalls were commonly attributed to device design (31.4%), process control (16.1%), or component design or ...

With medical devices, recalls are not always what they seem. In some recalls, including some of the most serious, the FDA and the manufacturers let doctors and hospitals continue to use the devices.

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said. “Use of this device may cause serious injuries or death ...

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device—“a Class I recall, the most serious type,” the FDA said. “Use of this device may cause serious ...

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — "a Class I recall, the most serious type," the FDA said. "Use of this device may cause serious injuries or ...

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals. This article was published on Thursday, August 15, 2024 in KFF ...