Class 3 Device Recall Thoratec

• Date Initiated by Firm: December 16, 2002
• Date Posted: January 30, 2003
• Recall Status: Terminated 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: 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