Vasoview Hemopro 2 — Class I medical device recall Z-0712-2025
Ongoing recall by Maquet Cardiovascular, LLC, reported 2025-01-15, distributed nationwide. Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of t
| Recall number | Z-0712-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2024-12-09 |
| Classified | 2025-01-03 |
| Reported by FDA | 2025-01-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BH, CA, CH, CZ, DE, DK, ES, FI, FR, GT, HK, IE, IN, IQ, IR, IT, JO, JP, KE, KR, KW, MX, MY, NL, NZ, OM, PA, PH, PL, PT, QA, SA, SE, SG, TR, ZA |
| Quantity | 11,101 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00607567700451 |
| Model numbers | VH-4001 |
Product
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Reason for recall
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
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-0712-2025. 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.