FDA WARNING_LETTER - Edwards Lifesciences, LLC - September 16, 2009

On September 9-16, 2009, an FDA inspection of Edwards Lifesciences, LLC in Irvine, California, revealed that their Carpentier-McCarthy-Adams IMR ETlogix Mitral Annuloplasty Ring, IMR ETlogix Mitral Annuloplasty Ring, Edwards dETlogix Annuloplasty Ring, and Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis devices were misbranded. The firm failed to furnish material or information required by section 519 of the Act and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation.

Specifically, the firm failed to report information suggesting a device may have caused or contributed to a death or serious injury within 30 calendar days, as required by 21 CFR Sec. 803.50(a)(1). Six specific complaints (HVT001766, HVT001938, HVT002195, HVT001277, HVT001271, HVT001300) involving death or serious injury were not reported within the required timeframe.

The FDA requires prompt corrective action to prevent regulatory actions such as seizure, injunction, and/or civil money penalties. Federal agencies are also advised of Warning Letters for device-related issues when considering contracts. Edwards Lifesciences,