Maquet Cardiovascular, LLC HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Brand
Maquet Cardiovascular, LLC
Lot Codes / Batch Numbers
Serial Numbers: 1126809369 1128053768 1183546961 1158773400
Products Sold
Serial Numbers: 1126809369 1128053768 1183546961 1158773400
Maquet Cardiovascular, LLC is recalling HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T due to Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026