Z-0015-2007

Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model...

Name: Z-0015-2007 Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model...
Creator: Thoratec Corp
Published: 2004-01-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-01-26 / Terminated

FDA source

Thoratec Corp began a recall of Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Number(s): Catalogue numbers: #100118-- Short, 14mm... on 2004-01-26. The reason FDA records is "During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0015-2007
Status: Terminated
Initiated: 2004-01-26
Posted: 2006-10-04
Terminated: 2007-11-27
Recalling firm: Abbott Medical
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
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.
FDA 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 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.
Product codes and lots: Serial Numbers: 104, 106

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)