As of March 18, four patients have died, and 2,557 serious injuries have been reported by Boston Scientific in patients with Accolade pacemakers. The company has issued a correction to affected ...

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 ...

The Food and Drug Administration said Boston Scientific will upgrade certain pacemakers to a new software as part of a recall. Boston Scientific issued a letter to affected customers recommending all ...

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 ...

Boston Scientific Corp. made an unexpected, $25 billion takeover offer Monday for the troubled medical device maker Guidant Corp., more than $3 billion more than what Johnson & Johnson agreed to pay ...

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 ...

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.

A prominent European court has ruled that Boston Scientific’s German branch is responsible for paying the surgical costs associated with replacing faulty implantable devices made by one of the company ...

Highest-risk classification: FDA labeled Boston Scientific’s pacemaker recall as Class I, the most serious, due to potential for injury or death. Software fix required: Devices remain in use but need ...

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 ...