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 ...

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 ...

VVeno Medical (Nasdaq:NVNO) announced three-year outcomes for its heart valve that it aims to submit to the FDA this year.

The SOLVE-CRT trial has delivered promising results for heart ... devices—pacemakers, ICDs, or CRTs—using a subcutaneous ultrasound Transmitter to power an ultra-compact Electrode implanted ...

This is a Class 1 recall, which the FDA says is the most serious type of recall, and use of the device can lead to serious injury or death. The recall is for Version 2.7 of the t:connect mobile ...

Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.