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U.S. Department of Health and Human Services

Class 3 Device Recall Thoratec

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  Class 3 Device Recall Thoratec see related information
Date Initiated by Firm December 16, 2002
Date Posted January 30, 2003
Recall Status1 Terminated 3 on August 21, 2003
Recall Number Z-0491-03
Recall Event ID 25262
PMA Number P870072S012 
Product Classification Ventricular (Assist) Bypass - Product Code DSQ
Product Thoratec Sterile LVAD Pneumatic Lead 5'' ;
Model/Product Number: 20010-0000-108
Code Information Lot Number: 17482
Recalling Firm/
Manufacturer		 Thoratec Corp
6035 Stoneridge Drive
Pleasanton CA 94588
Manufacturer Reason
for Recall		 The product is mislabeled, in that the LVAD Pneumatic Lead 5' is identified with a BLUE Collar (instead of Red) in order to distinguish RVAD.
FDA Determined
Cause 2		 Other
Action On 12/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.
Quantity in Commerce 45 units
Distribution The unit containing the affected product was shipped to a total of 25 hospitals in IL, PA, NY, TX, WI, FL, IN, WA, OK, AL, and WA-DC. The recall was appropriately extended to the consumer/user level; i.e., the hospitals, which received the recalled product. There is no known U. S. Government accounts but there are 3 foreign accounts: Canada, France and Spain.
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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