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.
FDA Recall Z-1427-2010 · Posted 2010-04-23
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Recalling FirmIntervascular S.A.S.
Recall StatusTerminated
Product CodeDSY
Date Initiated2009-12-09
Date Terminated2010-04-27
Product Quantity9
Reason for Recall
Packaging was mislabeled.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution - Arizona.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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