medical Class III Updated 2022-07-06

Volcano Corp recalls Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN:

Recalled Product

Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797

Hazard / Issue

Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329
View official government recall

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