FDA WARNING_LETTER - Thoratec Corporation - September 07, 2011

On January 3, 2012, the FDA issued a Warning Letter to Thoratec Corporation following an inspection from August 22 to September 7, 2011, at their Pleasanton, California facility. The inspection revealed that Thoratec's Ventricular Assist Device Systems (Thoratec, HeartMate XVE, and HeartMate II) were misbranded under Section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act due to failures in Medical Device Reporting (MDR) as required by 21 CFR Part 803.

Significant violations included: 1. Failure to report a death within 90 calendar days (Complaint 201008-0145, aware April 30, 2010, MDR received August 17, 2010). 2. Failure to report a device malfunction likely to cause death or serious injury if it recurred, within 90 calendar days (Complaint 201011-0160, aware November 11, 2010, MDR received March 21, 2011).

Thoratec's September 23, 2011, response regarding MDRs was deemed inadequate as it did not sufficiently address steps to prevent future late reporting.

Additionally, the FDA noted quality system deficiencies