Voluntary Medical Device Correction

Information for patients about FDA cardiovascular-related product approvals, safety warnings, notices of upcoming public meetings, and notices about proposed regulatory guidances.

Thoratec Issues Voluntary Device Correction

09/15/2015 06:44 PM EDT

Yesterday, Thoratec Corporation (NASDAQ: THOR) issued a voluntary Urgent Medical Device Correction Letter to all hospitals who have patients supported with the HeartMate II LVAS reminding them to monitor the expiration date of the backup battery contained within the HeartMate II “Pocket” System Controller, as specified in the product Instructions for Use. This backup battery has a 36 month expiration date.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Helene Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the Cardiovascular & Endocrine Liaison Program visit the FDA Patient Network