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U.S. Department of Health and Human Services

Class 2 Device Recall Thoratec

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 Class 2 Device Recall Thoratecsee related information
Date Initiated by FirmJanuary 26, 2004
Date PostedOctober 04, 2006
Recall Status1 Terminated 3 on November 27, 2007
Recall NumberZ-0015-2007
Recall Event ID 36138
PMA NumberP920014 P870072 
Product Classification arterial cannula - Product Code DSQ
ProductThoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Number(s): Catalogue numbers: #100118-- Short, 14mm graft; #100121-- Long, 14mm graft; #100129-- Long, 18mm graft. Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
Code Information Serial Numbers: 104, 106
Recalling Firm/
Manufacturer		 Thoratec Corp
6035 Stoneridge Drive
Pleasanton CA 94588-3270
For Additional Information ContactDonald A. Middlebrook
925-730-4117
Manufacturer Reason
for Recall		During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.
FDA Determined
Cause 2		Other
ActionOn 1/26/2004, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
Quantity in Commerce11 units
DistributionNationwide to 11(eleven) hospitals. The product was shipped within the United States in IL, MA, NC, MD, MO, FL, CA, AZ, PA, and NY. The product was distributed to one consignee in Australia.
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
PMAs with Product Code = DSQ
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