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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 Device Recall Thoratec Paracorporeal Ventricular Assist Devicesee related information
Date Initiated by FirmMarch 30, 2007
Date PostedJuly 27, 2007
Recall Status1 Terminated 3 on April 24, 2008
Recall NumberZ-1109-2007
Recall Event ID 38342
PMA NumberP870072 
Product Classification Paracorporeal Ventricular Assist Device - Product Code DSQ
ProductThoratec 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/
Manufacturer		 Thoratec Corp
6035 Stoneridge Drive
Pleasanton CA 94588
For Additional Information Contact
925-847-8600
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		Device Design
ActionThe 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 Commerce2,484 units
DistributionClass I Recall - Worldwide Distribution --- USA, Canada, Australia, Mexico, Singapore, Taiwan, Thailand, Austria, France, Germany, Israel, and Switzerland.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = DSQ
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