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Terminated

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

FDA Recall Z-0575-2007 · Posted 2007-03-08

Recalling FirmAbbott Vascular, Inc.
Recall StatusTerminated
Product CodeDYB
Date Initiated2007-01-31
Date Terminated2008-02-26
Product Quantity97,952 units

Reason for Recall

Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide distribution, including USA, Puerto Rico, and 410 other countries. There were no shipments to Canada and Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060902STARCLOSE INTRODUCER SET MODEL- 1002Abbott Vascular, Inc. · 2006-07-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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