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Recall Observatory FDA recall evidence

Device product

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Z-1875-2020

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-1875-2020

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: 1069033761 1069030839 1071600069 1071620833 1071615770 1071620950 1074557517 1074562931 1077531880 1109551893 1109625685 1113411073 1115932310 1160529586 1160492194 1160491552 1160727457 1160529957 1182769563 1182780936 1182789351 1182792017 1183481796 1069032514 1115876907 1115936362 1137588685

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