FDA Medical Device Recalls (openFDA)
St. Jude Medical / Daig Division: Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA.
- Recall number
- Z-0677-06
- Recalling firm
- St. Jude Medical / Daig Division
- Product
- Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA.
- Status
- Terminated
- Initiated
- 2005-08-22
- Posted
- 2006-03-25
- Terminated
- 2006-07-22
- Reason
- Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire.
- Root cause
- Other
- Action
- Letters were delivered to the hospitals and/or doctors in possession of the product instructing them to return it.
- Quantity
- 4160
- Distribution
- International Only-Belgium, China, Guadalajara, New Zealand and Thailand.
- Lot, serial or model codes
- Lot number 1146548
- 510(k) numbers
- not on file
- PMA numbers
- ["P930038"]
- Product code
- MGB
- Firm FEI
- 2182269
- Firm city
- Minnetonka
- Firm state
- MN
- 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