Z-0058-2011

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

Name: Z-0058-2011 HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS)...
Creator: Thoratec Corp
Published: 2010-09-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-09-01 / Terminated / root cause: design

FDA source

Thoratec Corp began a recall of HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as... on 2010-09-01. The reason FDA records is "Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0058-2011
Status: Terminated
Initiated: 2010-09-01
Posted: 2010-10-13
Terminated: 2011-04-07
Recalling firm: Abbott Medical
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
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: All serial numbers starting with EPC prefix

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)