FDA Medical Device Recalls (openFDA)
Intervascular S.A.S.: InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
- Recall number
- Z-1439-2010
- Recalling firm
- Intervascular S.A.S.
- Product
- InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
- Status
- Terminated
- Initiated
- 2009-12-09
- Posted
- 2010-04-28
- Terminated
- 2010-04-29
- Reason
- The external lid of Intervascular's prosthesis has a cut in it which may compromise package integrity and therefore sterility.
- Root cause
- Other
- Action
- The firm sent recall letters to all customers on December 9, 12009. Calls had been made prior to the letter being sent. Because all product was recovered, no additional questions are anticipated.
- Quantity
- 5
- Distribution
- US Distribution went to one distributor in Arizona. Also Chile, France, Germany, Hong Kong, Poland and Turkey.
- Lot, serial or model codes
- Product Reference Serial Number Lot number IGW1206 40199297 09J17 IGK2412 40200277 09J17 40200412 09J17 IGK0018-40 40200310 09J17 IGW0008-30 40199072 09J17
- 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