HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both

FDA device recall Z-0058-2011 · posted 2010-10-13 · Terminated

Recall details

Recalling firm

Thoratec Corp

Reason for recall

Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection

Action taken

Thoratec Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 30, 2010, to all customers. The letter described the affected product, description and symptoms of problem, and immediate action to be taken by the customers. The customers were instructed to: 1) contact all ongoing patients using the affected Systems Controllers (serial numbers starting with "EPC") to determine if they are experiencing any unexplained intermittent alarms or have any bent pins in the connectors between the System Controller and the power sources, if so, have them return to the hospital so that their power leads can be examined. If further assistance is needed with the evaluation, please contact Thoratec Technical Service (800-456-1477). 2) review the attached addendum to the HeartMate II labeling with all VAD clinicians and ongoing HeartMate II LVAS patients, and 3) complete and sign the attached Acknowledgment Form via fax to Thoratec Regulatory Affairs at (952) 847-8571. If you have any questions, please contact 925-847-8600.

Root cause

Device Design

Status

Terminated

Product code

DSQ

Quantity affected

8965 units

Distribution

Worldwide distribution: USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX , UT, VA, WA, and WI; and

Date initiated

2010-09-01

Date posted

2010-10-13

Date terminated

2011-04-07

Location

Pleasanton, CA