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U.S. Department of Health and Human Services

Class 1 Device Recall Thoratec Paracorporeal Ventricular Assist Device

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 Class 1 Recall
Thoratec Paracorporeal Ventricular Assist Device
see related information
Date Posted July 27, 2007
Recall Status1 Terminated on April 24, 2008
Recall Number Z-1109-2007
Recall Event ID 38342
Premarket Approval
PMA Number
Product Classification Ventricular (Assisst) Bypass - Product Code DSQ
Product Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000.
Code Information Catalog Number 14086-2550-000, bearing serial numbers 10745 or less
Recalling Firm/
Thoratec Corp
6035 Stoneridge Drive
Pleasanton, California 94588
Manufacturer Reason
for Recall
Incorrect collect nut assembly (inadvertent use of the incorrect (Black) collect nut) during surgical implantation (wrong size collect nut) to secure the inflow cannula to the PVAD has resulted in patient deaths
FDA Determined
Cause 2
Action The firm has issued an Urgent Medical Device Correction notice dated March 30, 2007, to all VAD customers alerting them to the hazard. The letter instructs them that a Thoratec representative will be contacting them to make arrangements to apply a warning label to the affected devices. The letter also informs them to dispose of any expired original design caged tip atrial cannula and to 1) not use the black collet and nut with any current design VAD, 2) make sure that all current patients using PVADs are using the appropriate collet nut, and 3) provide a copy of the product safety bulletin to all outlying hospitals and/or physicians that may be following patients implanted with PVADs and provide contact information with the acknowledgement form.
Quantity in Commerce 2,484 units
Distribution Class I Recall - Worldwide Distribution --- USA, Canada, Australia, Mexico, Singapore, Taiwan, Thailand, Austria, France, Germany, Israel, and Switzerland.
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.