MM&M

The FDA calls them ‘recalls,’ yet the targeted medical devices often remain in use

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 ...
TCTMD

Non-COAPT-Like Patients Fare Well With MitraClip, EXPAND Suggests

Chicago, IL—Real-world patients with mitral regurgitation (MR) not meeting the COAPT eligibility criteria who ultimately underwent clip-based transcatheter mitral valve repair fared just as well as ...
TCTMD

FDA, Abbott Warn of Potential MitraClip Locking Malfunctions

The US Food and Drug Administration and Abbott are warning physicians about the potential for clip lock malfunctions with MitraClip G4 and MitraClip NTR/XTR devices. The incidents have been observed ...
Becker's Hospital Review

FDA warns of potential clip lock issues on mitral valve devices

The FDA and Abbott are alerting healthcare providers about potential clip lock malfunctions with MitraClip Clip Delivery Systems, a heart valve repair device manufactured by Abbott. Abbott issued an ...
PBS

One medical device is raising questions about FDA’s approval process

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...
Medscape

COAPT Substudy Spotlights QOL Gains With MitraClip

NEW ORLEANS — To much acclaim, the COAPT trial demonstrated that use of the MitraClip (Abbott) in a very sick population with symptomatic (heart failure (HF) and secondary mitral regurgitation (MR) ...
MD&M East

FDA Warns Against Abbott MitraClip Malfunctions

The FDA yesterday released a statement to healthcare providers regarding potential clip lock malfunctions with Abbott’s MitraClip Clip Delivery Systems. MitraClip is a heart valve repair device ...