Boston Scientific recalls ICD due to short-circuit risk
Boston Scientific issued a recall for its implantable cardioverter defibrillator due to a manufacturing process that may allow moisture inside the defibrillator, causing a short-circuit in the delivery of high-voltage shocks.
Intended to provide electrical shock to stop dangerously fast heart rhythms and pacing for a short time after shocks if needed, a press release from the FDA noted that if moisture enters the device (Emblem S-ICD, Boston Scientific), patients may experience less shock than intended or may not receive a shock at all. The device may also beep, not respond to a device check-in and issue battery alerts, the release noted.
According to the release, the FDA has identified this as a class I recall, the most serious type, after it determined use of the device may cause serious injuries or death.
In December 2020, Boston Scientific sent at urgent medical device advisory to all affected customers with instructions to:
- enroll and monitor patients through remote monitoring (Latitude, Boston Scientific) to detect any alerts or artifacts on the devices in between office device checks;
- investigate any suspected indication of inability to interrogate, premature battery depletion or prolonged charge time alerts;
- evaluate the risk for life-threatening harm due to device malfunction; and
- replace any device suspected of exhibiting electrical overstress.
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