Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported January 15, 2025
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Maquet Cardiovascular, LLC recalled VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicate… - a critical-severity action.
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicate… was recalled by Maquet Cardiovascular, LLC in January 15, 2025. Reason: Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws …. Check the official notice for the remedy. Verify recall #Z-0711-2025 with the FDA Devices before acting.
The recall
Maquet Cardiovascular, LLC issued this critical-severity FDA Devices recall-Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws ….
- Critical
- severity level
- 418K units
- affected scope
- Class I
- classification
- January 15, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0711-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0711-2025) was formally reported on January 15, 2025, with the manufacturer initiating the action on December 9, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Maquet Cardiovascular, LLC is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as 418,076 units (326,608 US, 91,468 OUS), a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool Distribution data in the federal record shows the product reached: Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, India, Iran, Iraq, Ireland, Ital…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
418,076 units (326,608 US, 91,468 OUS)
Related Recalls
6
3 from same agency
Product description
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. 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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0711-2025 |
| Date reported | January 15, 2025 |
| Date initiated | December 9, 2024 |
| Recalling firm | Maquet Cardiovascular, LLC |
| Firm location | Wayne, NJ |
| Affected scope | 418,076 units (326,608 US, 91,468 OUS) |
| Distribution | Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Ke… |
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-0711-2025) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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.
Frequently Asked Questions
What product was recalled? ▼
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.. Recalled by Maquet Cardiovascular, LLC. Units affected: 418,076 units (326,608 US, 91,468 OUS).
Why was this product recalled? ▼
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 15, 2025. Severity: Critical. Recall number: Z-0711-2025.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, Netherlands, New Zealand, Oman, Panama, Puerto Rico, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0711-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 15, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.