Recall Z-1872-2020— Maquet Cardiovascular, LLC

Name: FDA recall Z-1872-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-07

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2020-04-07, terminated 2021-11-05. FDA's recall record names no specific 510(k) clearance for this event. Product: HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.. Reason: Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts.

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-04-07
Terminated: 2021-11-05
Firm location: Wayne, NJ, United States

Product description

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.