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.

Consumers Union recommends that the FDA: Require that implants and other "life-sustaining" devices be tested ... connect them to the heart. There have been two major recalls, in 2007 and ...

The US Food and Drug Administration (FDA) has approved the expansion of BiVACOR’s early feasibility study evaluating its titanium total artificial heart (TAH) to additional participants.

Abbott Laboratories has announced that its implantable heart device, MitraClip, has not been recommended for approval by reviewers at the US Food and Drug Administration. Clinical trials ...

The FDA has approved expanded labelling for Abbott's CardioMEMS HF System, an implantable sensor that provides an early warning of worsening heart failure, that could make it an option for more ...

Carmat is preparing to commence implants ... tumour. "FDA conditionally approves second cohort of Carmat’s artificial heart study" was originally created and published by Medical Device Network ...

Patients awaiting a heart transplant are often implanted with an ... and funding for pediatric heart devices. The network is working with the U.S. Food and Drug Administration (FDA) to expand ...

On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units ...