Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No — Class II medical device recall Z-2636-2025
Ongoing recall by Maquet Cardiovascular, LLC, reported 2025-10-01, distributed nationwide. Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled defor
| Recall number | Z-2636-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2025-08-06 |
| Classified | 2025-09-25 |
| Reported by FDA | 2025-10-01 |
| Distributed | Nationwide (US) |
| Quantity | 98 units |
| UPC / GTIN / UDI-DI | 00607567701274 |
| Serial numbers | 3000486429, 3000487231, 3000487726, 3000488639 |
| Model numbers | C-VH-6000 |
Product
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches. The HP3 Harvesting Tool features two curved, insulated jaws with heating elements that operate through heat and pressure rather than radiofrequency energy.
Reason for recall
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2636-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.