—#180795

Product

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

FDA product code: MAL — Graft, Vascular, Synthetic/Biologic Composite
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Serial Numbers: 1069016915 1069016778 1069024392 1069023633 1069020945 1069017069 1069887359 1070175211 1070689212 1070691938 1070692229 1073307657 1073274083 1074239734 1074508943 1076726963 1076724195 1076691012 1080515527 1080502574 1080516052 1080521115 1080517807 1080517202 1080511104 1082496280 1107410936 1107401196 1107412006 1108349382 1108384849 1109527236 1109536351 1109582959 1109545837 1109638521 1109712993 1112019301 1112016613 1112016964 1112016730 1112017860 1112017489 1112018385 1112051221 1112030283 1113457118 1113461382 1113412574 1113446562 1113429579 1115826461 1115864128 1115914431 1115914548 1115827123 1115899734 1115897708 1115825331 1115890109 1115890226 1116687063 1116670058 1116665366 1116796185 1118783633 1118872362 1118683489 1118680938 1118706076 1118855516 1118677296 1118857425 1118863618 1118853607 1118865156 1118868449 1120124949 1120151826 1120162616 1120197246 1120115580 1121427175 1121369492 1121368479 1121432004 1121402790 1121367720 1121381761 1121406257 1121461746 1121476608 1123956748 1124038791 1126619737 1126648874 1126652924 1126635453 1126606550 1139533672 1139548534 1139546508 1139558662 1139544833 1139556753 1139580083 1143639633 1145774258 1145827483 1145775271 1145857887 1146721149 1146735095 1146730264 1146737492 1146826241 1146794051 1146827488 1148863022 1150323725 1150325029 1150370975 1150390392 1150368503 1150338567 1150381414 1150319792 1150511214 1150545319 1150343259 1150599075 1150400300 1150603119 1151562307 1152518823 1152580288 1152720119 1152745089 1152748987 1152536448 1152735683 1152740863 1152618108 1160497045 1160563181 1160479908 1161618086 1161644067 1162218200 1162252517 1163879834 1163823544 1177064705 1177726014 1177810868 1177845264 1177799150 1177805708 1177743114 1177779362 1177757294 1177825964 1177745140 1177845030 1177719159 1177852470 1177816595 1177746524 1177754509 1177736376 1179122144 1179142049 1179115543 1181358135 1181256570 1181240695 1181268490 1183390553 1183404630 1183478311 1183415654 1183468651 1183413979 1187307214 1187389094 1187417095 1187330507 1187300825 1187835978 1187956786 1187944866 1193768558 1193816581 1193808479 1082495033 1112036986 1112023448 1118781236 1120191519 1136545831 1150382427 1152581184 1179154711 1181135879 1187301721 1187924473 1187392619

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

Getinge issued a customer notification - Urgent Medical Device Removal on April 7, 2020 via FedEx 2-day delivery with signature required. Letter states reason for recall, health risk, and action to take: Examine your inventory immediately to determine if you have any affected HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Graft and/or HEMASHIELD PLATINUM Woven Double Velour Vascular Graft products. If you have affected product that are listed in attachment 1 on page 5, please remove the affected products from areas of use. "If you have affected product to return, please contact Getinge Customer Support at (888) 9GETUSA / (888) 9438872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization number (RMA) and shipping instructions. Please fill out the customer response form on page 4 with the required information. "Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided. Please arrange for pickup with the designated delivery service provider. Whether you have the affected product or not, please complete and return the form (page 4) to acknowledge this recall by e-mailing a scanned copy to Hemashield2020.ACT@getinge.com or by faxing the form to (973) 807-9205 Questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 9GETUSA / (888) 9438872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

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.

Timeline

Recall initiated: 2020-04-07
Terminated: 2021-11-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180795. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.