FDA Medical Device Recalls (openFDA)
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 number
- Z-0015-2007
- Recalling firm
- Thoratec Corp
- 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
- Status
- Terminated
- Initiated
- 2004-01-26
- Posted
- 2006-10-04
- Terminated
- 2007-11-27
- Reason
- During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Serial Numbers: 104, 106
- 510(k) numbers
- not on file
- PMA numbers
- ["P920014","P870072"]
- Product code
- DSQ
- Firm FEI
- 2916596
- Firm city
- Pleasanton
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28