FDA Devices recall · Reported July 3, 2024
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 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. Th
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.
Maquet Cardiovascular, LLC recalled The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1.… - a moderate-severity action.
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1.… was recalled by Maquet Cardiovascular, LLC in July 3, 2024. Reason: Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the devic…. Check the official notice for the remedy. Verify recall #Z-2175-2024 with the FDA Devices before acting.
The recall
Maquet Cardiovascular, LLC issued this moderate-severity FDA Devices recall-Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the devic….
- Moderate
- severity level
- 430K units
- affected scope
- Class II
- classification
- July 3, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2175-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2175-2024 |
| Date reported | July 3, 2024 |
| Date initiated | May 17, 2024 |
| Recalling firm | Maquet Cardiovascular, LLC |
| Firm location | Wayne, NJ |
| Affected scope | 430,037 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia Brazil, Canada, China, EEA, India, Korea, New Zealand, Southern Africa, Taiwan, Thailand, Turkey, & United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2175-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026