Z-0412-2007

Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers...

Name: Z-0412-2007 Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers...
Creator: Thoratec Corp
Published: 2004-09-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-09-24 / Terminated

FDA source

Thoratec Corp began a recall of Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005, 10025-2601-007, 10025-2602-006... on 2004-09-24. The reason FDA records is "The module power switch (at the back of console) may break while attempting to turn the Dual Drive Console OFF or ON". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0412-2007
Status: Terminated
Initiated: 2004-09-24
Posted: 2007-02-10
Terminated: 2008-04-18
Recalling firm: Abbott Medical
Product: Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005, 10025-2601-007, 10025-2602-006, Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: The module power switch (at the back of console) may break while attempting to turn the Dual Drive Console OFF or ON.
FDA root cause: Other
Action: The firm issued on 1/25/07 an URGENT: MEDICAL DEVICE CORRECTION-notice informing its consignees about the 'Power Switch Replacement Instructions' and arrangements for their service department replacement of the switches.
Quantity in commerce: 331
Distribution: Worldwide
Product codes and lots: All Dual Drive Consoles manufactured before July 10, 2002 with serial numbers between 301 and 636, inclusive

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)