# FDA recall Z-2636-2025

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2025-08-06.

## 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.

## Distribution

US Nationwide distribution in the states of FL, IL, MD & TX.

## Key facts

- **Recall number:** Z-2636-2025
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-06
- **Report date:** 2025-10-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2636-2025

## Citation

> AI Analytics. FDA recall Z-2636-2025. Retrieved 2026-08-20 from https://api.ai-analytics.org/recall/Z-2636-2025. Source: US FDA. Licensed CC0.

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