Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Thoratec

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Thoratec see related information
Date Initiated by Firm January 26, 2004
Date Posted October 04, 2006
Recall Status1 Terminated 3 on November 27, 2007
Recall Number Z-0015-2007
Recall Event ID 36138
PMA Number P920014 P870072 
Product Classification arterial cannula - Product Code DSQ
Product Thoratec 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 Contact Donald 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
Action On 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 Commerce 11 units
Distribution Nationwide 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 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 CORP.
PMAs with Product Code = DSQ and Original Applicant = THORATEC LABORATORIES CORP.
-
-