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 ...
May 7 (Reuters) - Boston Scientific has issued an urgent recall to correct several heart devices after the U.S. Food and Drug ...
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 ...
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.
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 ...
In an interview, a senior Boston Scientific executive shares new information on the company's competing device to Medtronic's Micra and St. Jude Medical's Nanostim leadless pacemakers. We know about ...
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 ...