InterGard Knitted Collagen Coated Vascular prostheses… recallZ-1427-2010 · 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
Packaging was mislabeled.
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-1427-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 9, 2009
- Posted by the FDA
- Apr 23, 2010
- Recalling firm
- Intervascular S.A.S.
- Quantity
- 9
- Product code
- DSY
- FDA submissions
- K964625
- Distribution
- Nationwide Distribution - Arizona.
Product description
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.
Code information (models, lots, serial numbers)
Serial Number: 40246657, Lot number: 09M03.
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.
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