The U.S. Food and Drug Administration has issued an urgent safety alert after an electric malfunction in some older Boston Scientific pacemakers was linked to two reported deaths and early device ...
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 ...
The FDA is boosting a recall effort from Boston Scientific regarding batteries potentially underpowering a number of the company’s implanted Accolade pacemakers, which may need to be replaced earlier ...
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 ...
In a safety communication dated December 16 posted to the site of the FDA, the agency stated: “The U.S. Food and Drug Administration is alerting patients, caregivers, and health care providers about ...
Several brands of Boston Scientific pacemakers are under recall due to a risk that the devices can permanently enter Safety Mode, according to an alert issued by the US Food and Drug Administration.
WASHINGTON (AP) — U.S. health regulators are warning doctors and patients about safety issues with two separate Boston Scientific heart devices recently linked to injuries and deaths. The Food and ...
The FDA is further elevating a pacemaker recall from Boston Scientific that it first broadcast in December over certain Accolade implants that can place themselves into a permanent safety mode and may ...
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 ...
BRUSSELS, March 5 (Reuters) - U.S. medical device maker Boston Scientific Corp's German arm is liable for the cost of operations to replace potentially defective pacemakers, Europe's top court ruled ...