StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677; Product is manufactured by: A
FDA device recall Z-0575-2007 · posted 2007-03-08 · Terminated
Recall details
- Recalling firm
- Abbott Vascular, Inc.
- Reason for recall
- Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 97,952 units
- Distribution
- Worldwide distribution, including USA, Puerto Rico, and 410 other countries. There were no shipments to Canada and Mexico.
- Date initiated
- 2007-01-31
- Date posted
- 2007-03-08
- Date terminated
- 2008-02-26
- Location
- Redwood City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STARCLOSE INTRODUCER SET MODEL- 1002 (K060902) | Abbott Vascular, Inc. | 2006-07-07 |