FDA Medical devices recall ·
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0712-2025
- Date
- (initiated December 9, 2024)
- Company / brand
- Maquet Cardiovascular, LLC
45 Barbour Pond Dr, Wayne, NJ, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 11,101 units US
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: VH-4001. UDI-DI: 00607567700451. All unexpired Lots.
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.
States: Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0712-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.