FDA Medical Device Recalls (openFDA)
Intervascular S.A.S.: InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.
- Recall number
- Z-1427-2010
- Recalling firm
- Intervascular S.A.S.
- Product
- InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.
- Status
- Terminated
- Initiated
- 2009-12-09
- Posted
- 2010-04-23
- Terminated
- 2010-04-27
- Reason
- Packaging was mislabeled.
- Root cause
- Labeling mix-ups
- Action
- InterVascular SAS issued a "Recall Notification - Product Recall RC 020" notification dated January 29, 2009 to the sole consignee. The consignee had previously been notified by phone and all affected product had been segregated. For further information, contact InterVascular SAS at +33 442 08 77 84.
- Quantity
- 9
- Distribution
- Nationwide Distribution - Arizona.
- Lot, serial or model codes
- Serial Number: 40246657, Lot number: 09M03.
- 510(k) numbers
- ["K964625"]
- PMA numbers
- not on file
- Product code
- DSY
- Firm FEI
- 3002707083
- Firm city
- La Ciotat Cedex
- Firm state
- not on file
- Firm country
- France
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