Boston Scientific recalls pacemakers for software upgrade

12 articles · Updated · MarketWatch · May 7

The FDA said affected Accolade and cardiac resynchronization therapy pacemakers should receive Brady SMR6 after four deaths and 2,557 serious injuries were reported by March 18.
The update addresses risks from earlier software, including misread test results when a magnet is present and a prolonged voltage recovery state that could leave battery status or diagnostics stuck.
The FDA classified the action as its most serious recall type, warning continued use without correction could cause serious injury or death.

After 4 deaths and years of warnings, can 1.6 million pacemaker patients trust this new software fix?

Beyond a software patch, how can the medical industry prevent the next life-threatening device failure?

What allowed a fatal pacemaker flaw to be deployed to millions before this Class I recall was issued?