FDA Medical Device Recalls (openFDA)
Abbott Vascular, Inc.: 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
- Recall number
- Z-0575-2007
- Recalling firm
- Abbott Vascular, Inc.
- 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
- Status
- Terminated
- Initiated
- 2007-01-31
- Posted
- 2007-03-08
- Terminated
- 2008-02-26
- Reason
- Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.
- 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
- 97,952 units
- Distribution
- Worldwide distribution, including USA, Puerto Rico, and 410 other countries. There were no shipments to Canada and Mexico.
- Lot, serial or model codes
- Lot Numbers starting from 43034-6H to 47139-6H
- 510(k) numbers
- ["K060902"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3000718335
- Firm city
- Redwood City
- 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