VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500

FDA Device Recall #Z-0092-2025 — Class I — September 20, 2024

Recall Summary

Recall Number Z-0092-2025
Classification Class I — Serious risk
Date Initiated September 20, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Maquet Cardiovascular, LLC
Location Wayne, NJ
Product Type Devices
Quantity 28,809 units

Product Description

VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500

Reason for Recall

There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.

Distribution Pattern

Worldwide distribution. US Nationwide. Brazil, China, and Hong Kong.

Lot / Code Information

UDI-DI: VH-3000-W - 00607567700413, VH-3500 - 00607567701250; Lot Numbers: VH-3000-W: 3000365379, 3000382334, 3000392749; VH-3500: 3000333967 3000354228 3000364520 3000376542 3000384902 3000400713 3000339701 3000355224 3000365391 3000376883 3000385174 3000401094 3000340534 3000355369 3000366446 3000377320 3000385849 3000401623 3000341133 3000355798 3000366831 3000377699 3000386206 3000402378 3000341675 3000356048 3000367160 3000378079 3000386871 3000403161 3000342250 3000357837 3000367439 3000378654 3000387986 3000403837 3000342251 3000360574 3000367542 3000379282 3000387987 3000404029 3000343264 3000360576 3000367852 3000379691 3000388401 3000404374 3000343266 3000360775 3000368165 3000380264 3000388676 3000404720 3000344887 3000361036 3000368658 3000380475 3000389329 3000411951 3000345068 3000361423 3000369005 3000380671 3000392530 3000346640 3000361707 3000369122 3000381049 3000392531 3000351187 3000362064 3000369645 3000381287 3000393159 3000351376 3000362258 3000370069 3000381620 3000393427 3000351407 3000362671 3000370290 3000382054 3000393838 3000351619 3000362933 3000372257 3000382868 3000394234 3000351747 3000363162 3000375534 3000383367 3000395128 3000351860 3000363947 3000375776 3000383779 3000398856 3000352770 3000364082 3000376132 3000384088 3000399341 3000354226 3000364309 3000376388 3000384382 3000399911

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-2587-2025 Class II Heartstring III Proximal Seal System, 3.8 MM. I... Aug 15, 2025
Z-2588-2025 Class II Heartstring III Proximal Seal System, 4.3 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.