The FDA has declared a second Class I recall within a month on a Boston Scientific implantable cardioverter defibrillator (ICD).
This recall, which the company initiated with a trio of warnings in December, notified physicians that 3,350 Emblem S-ICD model A209 and A219 devices may exhibit electrical overstress while delivering high-voltage therapy. Variations in header assembly may allow a “very small pathway” to develop, allowing moisture to penetrate the device and cause it to short out during high-voltage therapy, the warning said.
If this happens during use, 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, according to an FDA recall notice. A defibrillator with the manufacturing error may delay or prevent the device from delivering a lifesaving electrical shock to a person in cardiac arrest and lead to serious injury or death. Additional surgeries may also be needed to replace failed devices, the agency said.
Boston Scientific said in December that it had confirmed six events of such electrical overstress, with the most common clinical outcome being early device replacement. No serious injuries were reported and the advisories provided guidance for physicians whose patients have the affected implants, the company said.
The FDA’s classification covers only 2,825 devices distributed in the U.S. between June 1, 2015, and Sept. 30, 2019.
“No devices within this advisory subset are still available for implant,” company spokesman Steve Bailey told Medical Design & Outsourcing in an email. “Guidance for patients or physicians has not changed since the time of the December announcement.”