FDA recall Z-0092-2025

Maquet Cardiovascular, LLC · Class I · device

Product

VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500

Reason for recall

There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.

Distribution

Worldwide distribution. US Nationwide. Brazil, China, and Hong Kong.

Key facts

Status
Ongoing
Initiation date
2024-09-20
Report date
2024-11-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0092-2025