FDA-Device2017-03-22Class II

VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.

Maquet Cardiovascular, LLC
Hazard

Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power.

Sold states
US Nationwide Distribution
Affected count
4283 units
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1456-2017

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