The FDA has issued a safety alert for several models of Boston Scientific’s Endotak Reliance defibrillation leads after identifying a serious defect linked to 16 deaths and 386 injuries. The leads, ...

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 ...

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 ...

The FDA issued a correction related to a recall of Boston Scientific (NYSE:BSX) defibrillation leads, labeling it the most ...

Boston Scientific has announced it has received FDA approval its INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers, according to a news release. The INGENIO and ...

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.

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 Food and Drug Administration (FDA) said on Wednesday it is monitoring a potential safety issue involving Boston Scientific Corporation’s BSX ENDOTAK RELIANCE defibrillation leads, following a ...

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 ...

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 ...