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Recall Observatory FDA recall evidence

Device product

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Z-1879-2020

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-1879-2020

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: 1130028529 1138737382 1151582817 1151580283 1153694149 1158765278 1165139009 1165161757 1165201073 1165174827 1165129349 1165209939 1165131353 1165124986 1180826106 1138872368 1153712022 1157288202 1158765044 1165159382

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