Medical device recalls Moderate risk

Maquet Cardiovascular, LLC recalls VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed fo…

Recall date
January 27, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1456-2017
FDA classification
Class II
Brand / firm
Maquet Cardiovascular, LLC
Sold / distributed
US Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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