—#125888

Product

HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart.

FDA product code: DSQ — Ventricular (Assist) Bypass
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P060040
Affected lot / code info: Catalog number 106762 (NAm) 106017 - EU all serial numbers

Why it was recalled

Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.

Root cause (FDA determination)

Device Design

Action the firm took

Thoratec sent an Urgent Medical Device Correction letter dated March 4, 2014 to all affected customers. The letter was sent via e-mail. All distributors outside of the USA and Canada to whom affected product has been distributed have been notified of this field correction notice and have been provided copies of the Customer Letter to forward to their customers. The letter identified the affected product , problem and actions to be taken. Customers were requested to complete and sign the attached Acknowledgement Form and return it to Thoratec via fax (925-847-8571) or e-mail a scanned copy to customer.service@thoratec.com. For questions call 1-800-528-2577.

Recalling firm

Firm: Thoratec Corporation
Address: 6035 Stoneridge Dr, Pleasanton, California 94588-3270

Distribution

Distribution pattern: Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.

Timeline

Recall initiated: 2014-03-04
Posted by FDA: 2014-03-21
Terminated: 2015-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125888. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.