Z-0575-2007

StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677; Product is...

Name: Z-0575-2007 StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677; Product is...
Creator: Abbott Vascular, Inc.
Published: 2007-01-31
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2007-01-31 / Terminated

FDA source

Abbott Vascular, Inc. began a recall of StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677; Product is manufactured by: Abbott Vascular Inc., 400 Saginaw Drive... on 2007-01-31. The reason FDA records is "Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0575-2007
Status: Terminated
Initiated: 2007-01-31
Posted: 2007-03-08
Terminated: 2008-02-26
Recalling firm: Abbott Vascular
Product: StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677; Product is manufactured by: Abbott Vascular Inc., 400 Saginaw Drive, Redwood City, CA 94063
Product code: DYB Introducer, Catheter
Reason for recall: Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.
FDA root cause: Other
Action: On 1/31/07, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned to its sales rep.
Quantity in commerce: 97,952 units
Distribution: Worldwide distribution, including USA, Puerto Rico, and 410 other countries. There were no shipments to Canada and Mexico.
Product codes and lots: Lot Numbers starting from 43034-6H to 47139-6H

Product code DYB

K060902Class IIStarclose Introducer Set Model- 1002Abbott Vascular, Inc. / cleared 2006-07-07

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)