medical Class II Updated 2020-05-13

Maquet Cardiovascular, LLC recalls HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Bra

Recalled Product

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.


Hazard / Issue

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 1161660408 1161660759 1161660154 1168595437 1168596216 1168588836 1168591619 1168601507 1168586068 1174957059 1174946035
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