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U.S. Department of Health and Human Services

Class 2 Device Recall Thoratec Dual Drive Console

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  Class 2 Device Recall Thoratec Dual Drive Console see related information
Date Initiated by Firm September 24, 2004
Date Posted February 10, 2007
Recall Status1 Terminated 3 on April 18, 2008
Recall Number Z-0412-2007
Recall Event ID 36154
PMA Number P870072 
Product Classification Ventricular Assist Device console - Product Code DSQ
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
Code Information All Dual Drive Consoles manufactured before July 10, 2002 with serial numbers between 301 and 636, inclusive
Recalling Firm/
Manufacturer		 Thoratec Corp
6035 Stoneridge Drive
Pleasanton CA 94588
For Additional Information Contact Gary D. Cederwall
925-730-4118
Manufacturer 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 Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = DSQ and Original Applicant = THORATEC LABORATORIES CORP.
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