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 ...
Boston Scientific has issued a critical recall on several heart devices after the FDA classified the action as serious. Affected devices must undergo a software update to prevent severe injury or ...
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 ...
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 ...