Boston Scientific, a Marlborough medical device manufacturer, has recalled a subset of its Accolade pacemakers due to battery issues leading to malfunctions, where two patient deaths have been ...
Boston Scientific said in the letter that it is actively developing a software update for the affected devices designed to detect on the onset of a high impedance battery state and display an alert.
The devices are being recalled due to an increased risk for permanently entering Safety Mode. HealthDay News — Boston Scientific has issued a recall of Accolade pacemaker devices, according to a ...
Boston Scientific has recalled its Accolade pacemaker devices due to a manufacturing issue that could cause the devices to enter safety mode, requiring replacement. The FDA has classified the recall ...
Guidant, a subsidiary of Natick, Mass.-based Boston Scientific, has agreed to pay $9.25 million to settle False Claims Act charges over the company’s alleged cost inflation for pacemakers and ...
FDA yesterday published a safety communication indicating the potential need for Boston Scientific Accolade pacemaker devices to be replaced early after finding a manufacturing issue with the battery ...
TUESDAY, Feb. 25, 2025 (HealthDay News) -- Boston Scientific has issued a recall of Accolade pacemaker devices, according to a safety communication from the U.S. Food and Drug Administration. The ...