Thoratec Corp 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Thoratec Corp
Lot Codes / Batch Numbers
Serial Numbers: 104, 106
Products Sold
Serial Numbers: 104, 106
Thoratec Corp is recalling Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Mod due to During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026