FDA warns Thoratec on late filings

January 13, 2012 by MassDevice staff

The FDA issues a warning letter to Thoratec Corp. over the late filing of a pair of medical device reports, but the company says regaining the agency's good graces won't impact its operations or finances.


Thoratec Corp. (NSDQ:THOR) said the FDA sent it a letter warning about a pair of late filings with the federal watchdog agency, adding that resolving the issue shouldn't affect its operations or finances.

The warning letter, which the heart pump maker said it received Jan. 4, flagged the late reports after inspections in August and September 2011 brought them to light, according to a regulatory filing.

"The company believes that the FDA’s concerns set forth in the warning letter can be resolved without a material impact to the company’s financial results," according to the filing. "In particular, we do not expect either customer orders or our ability to manufacture or ship products to be impacted by the warning letter."

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Thoratec has 15 days to respond and has already put preventative measures in place, according to Leerink Swann analyst Rick Wise.

Thoratec "emphasized that while any warning letter is serious, this particular warning letter is not likely to impact product sales and/or production as it's more of a documentation issue," Wise wrote in a note to investors. "Though clearly a negative headline that could pressure THOR shares tomorrow morning, we're inclined to think this warning letter will not fundamentally impact the business and is not representative of a broader, more systemic issue."

THOR shares were down about 1%, to $29.71, as of about noon today.