Device product
AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Z-1759-2013
Product summary
- Event
- Event 65553
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1759-2013
Official wording
Reason: Blood blushing/leaking from the surface of the graft after implantation
Code information: Lot number/Expiration Date 56890A 2015-04
Distribution pattern: Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.
Derived failure modes
-
Unknown
Blood blushing/leaking from the surface of the graft after implantation