Device product
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Z-0711-2025
Product summary
- Event
- Event 95908
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 418,076 units (326,608 US, 91,468 OUS)
- Official record key
device-enforcement:Z-0711-2025
Official wording
Reason: Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Code information: Model Number: VH-4000. UDI-DI: 00607567700406. All unexpired Lots.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool