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Recall Observatory FDA recall evidence

Device product

AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Z-1766-2013

June 17, 2013

Class I

Product summary

Firm
LeMaitre Vascular, Inc.
Event
Event 65553
Status
Terminated
Classification
Class I
Quantity
2 units
Official record key
device-enforcement:Z-1766-2013

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

    reason.no_named_rule · v1.0.0

    Blood blushing/leaking from the surface of the graft after implantation