HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - ...
FDA Device Recall #Z-1873-2020 — Class II — April 7, 2020
Recall Summary
| Recall Number | Z-1873-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 7, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Maquet Cardiovascular, LLC |
| Location | Wayne, NJ |
| Product Type | Devices |
| Quantity | N/A |
Product Description
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Reason for Recall
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
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.
Lot / Code Information
Serial Numbers: 1069844373 1069859235 1070838372 1070706306 1070885876 1070696535 1070880206 1070698932 1070693359 1070875260 1070859895 1071599689 1071623404 1071635929 1071640855 1071595383 1072244650 1072221218 1072235164 1073312349 1074236187 1074521366 1075883407 1076662460 1076662089 1076657163 1076657651 1077516221 1077516455 1077512637 1077509366 1077515793 1077506795 1077514292 1077510006 1077509132 1080021177 1080028425 1080022190 1080038065 1080016505 1080020047 1080020906 1080022444 1080034247 1080026145 1107350739 1107370878 1107397055 1107542300 1107356954 1107534803 1111727076 1111767628 1111828116 1111802952 1111831484 1111976640 1111962791 1111974477 1111985521 1111988794 1111989573 1111991831 1111960882 1111934296 1113454547 1113439727 1113459983 1113457606 1113464792 1113410548 1113473439 1115874978 1115872835 1115914782 1115896441 1115917119 1115900231 1115900953 1115936616 1115917841 1115915444 1115918249 1116670546 1116664587 1116654947 1116679332 1116771449 1116675865 1116657147 1117803878 1117890119 1117889596 1123969330 1123996558 1124010762 1123975523 1123968785 1124016489 1124033238 1123954839 1124030667 1123982592 1124038069 1123990226 1124016977 1126833792 1129566390 1129565748 1131391775 1134353909 1134350733 1134353284 1134370267 1139544111 1139533926 1139541540 1139536009 1146817477 1150356075 1151513850 1151507306 1151527816 1151544428 1169424559 1169388690 1171544434 1171540733 1171618089 1171564710 1171541375 1173579328 1173699240 1182769446 1182698342 1182756864 1182709126 1184446354 1184412971 1184445946 1184453326 1184450033 1187301116 1187336000 1187866556 1189130132 1189111006 1190531014 1190781708
Other Recalls from Maquet Cardiovascular, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2586-2025 | Class II | Heartstring III Proximal Seal System. Intravas... | Aug 15, 2025 |
| Z-2588-2025 | Class II | Heartstring III Proximal Seal System, 4.3 MM. I... | Aug 15, 2025 |
| Z-2587-2025 | Class II | Heartstring III Proximal Seal System, 3.8 MM. I... | Aug 15, 2025 |
| Z-2636-2025 | Class II | Vasoview Hemopro 3 Endoscopic Vessel Harvesting... | Aug 6, 2025 |
| Z-1622-2025 | Class II | The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harves... | Mar 20, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.