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.

Get the full story on our sister site, Medical Design & Outsourcing.