—#180794

Product

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - 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
510(k) numbers: K021213
Affected lot / code info: Serial Numbers: 1070172386 1070172035 1070165805 1070170614 1069855417 1070722490 1070716317 1070692463 1070716668 1073219687 1073220795 1073223015 1074236324 1073239612 1074517570 1079999309 1079997985 1080000259 1080547235 1080509568 1080566478 1080564686 1108346226 1111646683 1111648592 1111705379 1111680044 1111803731 1111646078 1111719462 1115868785 1117833189 1117882017 1117871578 1117912903 1117878104 1117848422 1117847877 1118870707 1118858809 1118864514 1146813425 1146795181 1146785287 1146815568 1150324250 1150260235 1150306859 1150311668 1150308046 1150468978 1150337808 1150339112 1150343747 1170653063 1170656610 1170622485 1170679066 1177871479 1177878356 1177890859 1177920418 1179061656 1179078310 1179110087 1181320446 1185194855 1073228334 1074228944 1074241016 1073226893 1076688092 1079998881 1111672293 1113494240 1146788600 1150471761 1185747042 1185791370

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 #180794. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.