—#180797

Product

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - 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: 1071592227 1076652332 1076651924 1077530262 1077532425 1077534451 1115874139 1117809371 1117812408 1117796327 1117794535 1117789960 1117809020 1117815935 1117814805 1123951175 1123988085 1124019782 1124040327 1124021181 1124006732 1129589959 1129634943 1129655139 1136595906 1137613764 1139537978 1143684135 1146721032 1146770074 1146753833 1146714548 1146754846 1146767428 1160528085 1160522358 1160540588 1160489919 1185176976 1185742445 1187300337 1187355243 1187336585 1072226283 1115901732 1117786179 1124002055 1123995779 1137600948 1139535952 1143697322 1146723800 1146725221 1160566357

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 #180797. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.