InterGard Knitted Collagen Coated Vascular prostheses… recallZ-1439-2010 · Intervascular S.A.S. · initiated Dec 9, 2009
Terminated All recalls posted in April 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intervascular S.A.S. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The external lid of Intervascular's prosthesis has a cut in it which may compromise package integrity and therefore sterility.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1439-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 9, 2009
- Posted by the FDA
- Apr 28, 2010
- Recalling firm
- Intervascular S.A.S.
- Quantity
- 5
- Product code
- DSY
- FDA submissions
- K964625
- Distribution
- US Distribution went to one distributor in Arizona. Also Chile, France, Germany, Hong Kong, Poland and Turkey.
Product description
InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
Code information (models, lots, serial numbers)
Product Reference Serial Number Lot number IGW1206 40199297 09J17 IGK2412 40200277 09J17 40200412 09J17 IGK0018-40 40200310 09J17 IGW0008-30 40199072 09J17
Other devices under the same FDA submission
47 devices cleared under K964625 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Hemagard HGKAX0808Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter18 reports
- Hemagard HGK1407Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter15 reports
- Intergard IGK1608Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter9 reports
- Intergard IGK1407Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter7 reports
- Intergard IGK1809Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter7 reports
- Intergard IGK0008-40Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter7 reports
- Hemagard HGK1608Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter6 reports
- Hemagard HGKAX100808RS35/20Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter6 reports
- Intergard IGK0008-70Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter5 reports
- Intergard IGK2010Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter5 reports
- Intergard IGK0008RS45Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter5 reports
- Hemagard HGK1809Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page