Z-0157-2007

The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled...

Name: Z-0157-2007 The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled...
Creator: St. Jude Medical / Daig Division
Published: 2006-06-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-06-07 / Terminated / root cause: packaging

FDA source

St. Jude Medical / Daig Division began a recall of The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size on 2006-06-07. The reason FDA records is "The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0157-2007
Status: Terminated
Initiated: 2006-06-07
Posted: 2006-11-07
Terminated: 2006-11-13
Recalling firm: Abbott Medical
Product: The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size.
Product code: MGB Device, Hemostasis, Vascular
Reason for recall: The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire.
Root cause tag: packaging
FDA root cause: Other
Action: All consignees were notified by letter on June 7, 2006. All product is to be retreived by recalling firm''s sales force for return to St. Jude Medical, in Minnetonka, MN.
Quantity in commerce: 4,770 Units
Distribution: Nationwide.
Product codes and lots: Lot 1204437

Product code MGB

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)