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