Johnson & Johnson’s Abiomed has recalled automated controllers for its Impella heart pumps over a fault linked to three ...

Boston Scientific has issued a recall of Accolade pacemaker devices, according to a safety communication from the U.S. Food and Drug Administration.

Recalled heart devices often do not go through clinical testing, a new study found, highlighting growing concerns about the FDA’s medical device approval standards.

Just 30 of 157 heart devices with Class I recalls underwent premarket clinical testing, according to a study published in the Annals of Internal Medicine.

The analysis comes as regulators investigate how the FDA authorizes medical devices and handles safety recalls.

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When it comes to medical devices, recalls can include not only “removals,” but also “corrections,” which address the problem in the field.

News The FDA calls them ‘recalls,’ yet the targeted medical devices often remain in use When it comes to medical devices, recalls can include not only 'removals,' in which the device is removed from ...

The FDA calls them ‘recalls,’ yet the targeted medical devices often remain in use When it comes to medical devices, recalls can include not only “removals,” in which the device is removed ...

From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals.

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.

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.