The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction wit...
FDA Device Recall #Z-2176-2024 — Class II — May 17, 2024
Recall Summary
| Recall Number | Z-2176-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 17, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Maquet Cardiovascular, LLC |
| Location | Wayne, NJ |
| Product Type | Devices |
| Quantity | 37,186 units |
Product Description
The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
Reason for Recall
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia Brazil, Canada, China, EEA, India, Korea, New Zealand, Southern Africa, Taiwan, Thailand, Turkey, & United Kingdom.
Lot / Code Information
Model No. VH-3500, VH-3000-W; UDI: 00607567701250, 00607567700345; Lot No. 3000314373, 3000314821, 3000316023, 3000316024, 3000316027, 3000317501, 3000317575, 3000317576, 3000318302, 3000318901, 3000320140, 3000320141, 3000320773, 3000321483, 3000321723, 3000323214, 3000324397, 3000324409, 3000325013, 3000325249, 3000325689, 3000325776, 3000328206, 3000328561, 3000328562, 3000329723, 3000330445, 3000331131, 3000331388, 3000332428, 3000332510, 3000332993, 3000333524, 3000333829, 3000333956, 3000333967, 3000334315, 3000335670, 3000336708, 3000337272, 3000339701, 3000340534, 3000341133, 3000341675, 3000342250, 3000342251, 3000343264, 3000343266, 3000344887, 3000351187, 3000352770, 3000354226, 3000354228, 3000355224, 3000355369, 3000355798, 3000356048, 3000357837, 3000360574, 3000360576, 3000360775, 3000361036, 3000361423, 3000361707, 3000362064, 3000362258, 3000362671, 3000362933, 3000363162, 3000363947, 3000364082, 3000364309, 3000364520, 3000365379, 3000365391, 3000366446, 3000366831, 3000367160, 3000367439, 3000367542, 3000367852, 3000368165, 3000368658, 3000369005, 3000369122, 3000369645, 3000370069, 3000370290, 3000372257, 3000375534, 3000375776, 3000376132, 3000376388, 3000376542, 3000376883, 3000376883, 3000377320, 3000377699, 3000378079, 3000378654, 3000379282, 3000379691, 3000380264, 3000380475, 3000380671, 3000381287, 3000381620, 3000382054, 3000383367, 3000383779, 3000384088, 3000388588.
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.