Thoratec Corp: HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as components of the LVAS Implant kit. Manufactured/Distributed by Thoratec Corporation, Pleasanton, CA The HeartMate II Left Ventricular Assist System (LVAS) consists of an implantable blood pump connected to an eternal system controller by a percutaneous lead. The external controller is powered bye either batteries or a power supply that connects to AC Main power. The device is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. It is also for use in patients with New York Heart Association class IIIB or IV end-stage left ventricular

Recall number

Z-0058-2011

Recalling firm

Thoratec Corp

Product

HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as components of the LVAS Implant kit. Manufactured/Distributed by Thoratec Corporation, Pleasanton, CA The HeartMate II Left Ventricular Assist System (LVAS) consists of an implantable blood pump connected to an eternal system controller by a percutaneous lead. The external controller is powered bye either batteries or a power supply that connects to AC Main power. The device is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. It is also for use in patients with New York Heart Association class IIIB or IV end-stage left ventricular

Status

Terminated

Initiated

2010-09-01

Posted

2010-10-13

Terminated

2011-04-07

Reason

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

Root cause

Device Design

Action

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.

Quantity

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 countries including: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Netherlands, Singapore, Slovenia, Sweden, Switzerland, and the UK.

Lot, serial or model codes

All serial numbers starting with EPC prefix

510(k) numbers

not on file

PMA numbers

["P060040"]

Product code

DSQ

Firm FEI

2916596

Firm city

Pleasanton

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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