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
- Company
- Thoratec Corp
- Recall Initiated
- January 26, 2004
- Posted
- October 4, 2006
- Terminated
- November 27, 2007
- Recall Number
- Z-0015-2007
- Quantity
- 11 units
- Firm Location
- Pleasanton, CA
Reason for Recall
During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.
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.
Lot / Code Info
Serial Numbers: 104, 106
Root Cause
Other
Action Taken
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.
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