The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy pacemakers after identifying a software- ...

May 7 (Reuters) - Boston Scientific has issued an urgent recall to correct several heart devices after the U.S. Food and Drug ...

Highest-risk classification: FDA labeled Boston Scientific’s pacemaker recall as Class I, the most serious, due to potential ...

As of March 18, Boston Scientific has reported four deaths and 2,557 serious injuries associated with this issue, the FDA said. "The FDA has identified this recall as the most serious type. This ...

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.

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 ...

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.

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 ...

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 ...