Maquet Cardiovascular, LLC recalls HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use…

Recall date

April 7, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1867-2020

FDA classification

Class II

Brand / firm

Maquet Cardiovascular, LLC

Sold / distributed

Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.