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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 Recall
Thoratec Dual Drive Console
see related information
Date Posted February 10, 2007
Recall Status1 Terminated on April 18, 2008
Recall Number Z-0412-2007
Recall Event ID 36154
Premarket Approval
PMA Number
P870072
Product Classification Ventricular (Assisst) Bypass - 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, California 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
DESIGN: Device Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = DSQ and Applicant = MEDTRONIC INC.
PMAs with Product Code = DSQ and Applicant = THORATEC CORP.
PMAs with Product Code = DSQ and Applicant = THORATEC LABORATORIES CORP.
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