Z-0496-2009

Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog...

Name: Z-0496-2009 Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog...
Creator: Thoratec Corp
Published: 2008-10-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-10-24 / Terminated / root cause: design

FDA source

Thoratec Corp began a recall of Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog Number 102139. Product is manufactured and distributed... on 2008-10-24. The reason FDA records is "The firm has become aware that, over time, wear and fatigue of the percutaneous lead connecting the HeartMate II Left Ventricular Assist System (HM II LVAS) blood pump with external system controller may result in...". 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-0496-2009
Status: Terminated
Initiated: 2008-10-24
Posted: 2008-12-22
Terminated: 2011-01-26
Recalling firm: Abbott Medical
Product: Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog Number 102139. Product is manufactured and distributed by Thoratec Corporation, Pleasant, CA. The HM II LVAS is intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; either for temporary support, such as a bridge to cardiac transplantation or myocardial recovery, or as permanent destination therapy. The HeartMate II is intended for use inside or outside the hospital.
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: The firm has become aware that, over time, wear and fatigue of the percutaneous lead connecting the HeartMate II Left Ventricular Assist System (HM II LVAS) blood pump with external system controller may result in damage that has the potential to interrupt pump function and may require a reoperation to replace the pump.
Root cause tag: design
FDA root cause: Device Design
Action: An initial "Urgent: Medical Device Correction" letter dated October 21, 2008 and a follow-up letter dated October 24, 2008 were sent to affected HeartMate II Left Ventricular Assist System (HM II LVAS) customers. The letters identified the problem, immediate action and preventive action to be taken by customers and recommended that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. If customers suspect that a HM II LVAS patient may have a damaged percutaneous lead, please contact Thoratec Technical Services (800-456-1477) for assistance. A return response (Acknowledgement Form) was included with the letter for consignees to complete and fax it to Thoratec Regulatory Affairs at 925-847-8628. Direct questions to the Thoratec Regulatory Affairs Department at 925-730-4135 (Monday-Friday, 8 a.m.-5 p.m. PST). Clinicians and patients with questions may contact the firm at 800-528-2577, or if calling outside the USA, 925-847-8600 (7 days a week, 8 a.m.-5 p.m. PST). Copies of the press release may be found on the firm's website, www.thoratec.com, under Investor Relations/Press Releases.
Quantity in commerce: 2,335 units
Distribution: Worldwide Distribution.
Product codes and lots: All serial numbers.

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)