FDA and Boston Scientific have issued warning letters for certain Watchman Access Systems updating use instructions for the models. The early alert is part of a pilot program from FDA to enhance ...
The U.S. Food and Drug Administration is warning patients and doctors about possible issues seen with Boston Scientific heart devices. The FDA issued alerts on Aug. 6 about the Marlboro-based ...
The U.S. FDA posted an Aug. 6 early alert regarding the use of the Watchman left atrial appendage device by Boston Scientific Corp., citing instances in which the device’s delivery system is ...
Boston Scientific is recommending updates to the instructions for use (IFU) for certain access systems for its Watchman FLX left atrial appendage occlusion (LAAO) device to help mitigate the risk of ...
More special care is needed when using the Watchman access systems used to deliver transcatheter left atrial appendage (LAA) closure devices due to a risk for air embolisms, according to an FDA alert.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback