Endoscopic Vessel Harvesting System Recalled Due to Potential Cautery Malfunction
Maquet Cardiovascular recalls VasoView HemoPro 2 vessel harvesting systems due to potential fluid ingress that may prevent or unintentionally activate cautery function. The recall affects 430,037 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a surgical device with potential malfunction (loss of or unintended cautery activation during vessel harvesting). The hazard poses risk of harm in a surgical application, but no injuries or hospitalizations have been reported in the source text, meeting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the VasoView HemoPro 2 Endoscopic Vessel Harvesting System (Models VH-4000 and VH-4001). The system is designed for minimally invasive harvesting of blood vessels during cardiovascular surgery, with a harvesting tool that cuts and cauterizes vessel branches under endoscopic visualization.
The recall was issued because fluid may enter the handle of the harvesting tool, potentially causing the device to fail to provide cautery when needed or to deliver cautery unintentionally. This malfunction could compromise the safe and effective performance of the device during surgical procedures.
The recall affects 430,037 units worldwide, including units distributed to the United States and to Australia, Brazil, Canada, China, EEA, India, Korea, New Zealand, Southern Africa, Taiwan, Thailand, Turkey, and the United Kingdom.
Healthcare facilities and surgeons using this device should discontinue use and contact Maquet Cardiovascular for instructions on device replacement or corrective action.
The recalled product
- Product
- 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
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- fluid-ingress
- device-malfunction
- cautery-malfunction
Distribution
Distributed nationwide across the United States.
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