Skip to content
Recall Observatory FDA recall evidence

Device product

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Z-1869-2020

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-1869-2020

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: 1070624412 1072306151 1072300424 1123884494 1131457231 1131669419 1133302679 1151507540 1151511687 1152707813 1152559041 1152750757 1070621236 1070629009 1074513986 1074512017 1123911970 1131472773 1131605144 1152580776 1153707701

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