Device Recall InterGard Knitted Collagen Coated Vascular prostheses and InterGard Woven Collagen Coated Va

Model / Serial
Product Reference Serial Number Lot number IGW1206 40199297 09J17 IGK2412 40200277 09J17 40200412 09J17 IGK0018-40 40200310 09J17 IGW0008-30 40199072 09J17
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
Yes
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.
Manufacturer
Intervascular S.A.S.
1 Event
- Recall of Device Recall InterGard Knitted Collagen Coated Vascular prostheses and InterGard Woven Collagen Coated Va

Manufacturer

Intervascular S.A.S.

Manufacturer Address
Intervascular S.A.S., Zone Industrielle Athelia I, La Ciotat Cedex France
Manufacturer Parent Company (2017)
Getinge AB
Source
USFDA

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