Z-1439-2010

InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven...

Name: Z-1439-2010 InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven...
Creator: Intervascular S.A.S.
Published: 2009-12-09
License: https://open.fda.gov/license/

Intervascular SAS / initiated 2009-12-09 / Terminated / root cause: packaging

FDA source

Intervascular S.A.S. began a recall of InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under... on 2009-12-09. The reason FDA records is "The external lid of Intervascular's prosthesis has a cut in it which may compromise package integrity and therefore sterility". 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-1439-2010
Status: Terminated
Initiated: 2009-12-09
Posted: 2010-04-28
Terminated: 2010-04-29
Recalling firm: Intervascular SAS
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.
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall: The external lid of Intervascular's prosthesis has a cut in it which may compromise package integrity and therefore sterility.
Root cause tag: packaging
FDA 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 in commerce: 5
Distribution: US Distribution went to one distributor in Arizona. Also Chile, France, Germany, Hong Kong, Poland and Turkey.
Product codes and lots: Product Reference Serial Number Lot number IGW1206 40199297 09J17 IGK2412 40200277 09J17 40200412 09J17 IGK0018-40 40200310 09J17 IGW0008-30 40199072 09J17

Product code DSY

K964625Class IIHemapatch Vascular Patches, Intergard and Intergard-Rs Vascular ProsthesesIntervascular, Inc. / cleared 1997-05-05

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)