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Recall Observatory FDA recall evidence

Device 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.

Z-1877-2020

April 07, 2020

Class II

Product summary

Firm
Maquet Cardiovascular, LLC
Event
Event 85420
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1877-2020

Official wording

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

Code information: Serial Numbers: 1161660408 1161660759 1161660154 1168595437 1168596216 1168588836 1168591619 1168601507 1168586068 1174957059 1174946035

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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