Battery issue may cause device failure, injury, or death
The FDA has classified the Boston Scientific Accolade pacemaker recall as a Class I recall, the most serious type, due to risks of device failure, injury, or death.
Key Issue
- Affected pacemakers may enter Safety Mode unexpectedly due to high battery impedance, leading to underpowered device function.
- This can cause bradycardia (slow heartbeat), fainting, or death in pacemaker-dependent patients.
- 832 injuries and 2 deaths have been reported.
FDA & Boston Scientific’s Response
- Immediate replacement is recommended if a device enters Safety Mode in high-risk patients.
- Non-urgent replacement is advised for others.
- The company plans software updates and manufacturing improvements to prevent future failures.
Pacemaker patients should schedule regular follow-ups every 12 months and not rely on battery life estimates in Safety Mode.
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