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Terminated

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

FDA Recall Z-0412-2007 · Posted 2007-02-10

Recalling FirmThoratec Corp
Recall StatusTerminated
Product CodeDSQ
Date Initiated2004-09-24
Date Terminated2008-04-18
Product Quantity331

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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