FDA Devices Low Class III Ongoing

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

Reported: July 6, 2022 Initiated: May 13, 2022 #Z-1301-2022

Product Description

Reason for Recall

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

Details

Recalling Firm: Volcano Corp
Units Affected: 14.031 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of NY, CA, AZ, LA, NV, AL, MI, WI, CO, TX, NJ, OR, FL, KS, IL, MD, PA, OH, NC, OK, MN, AK, GA, MO, SC, MS, KY, AR, VA, SD, TN, MA, DE, NE, MT, CT, WV, WA, IN, IA, HI, NH, WY, UT, ID, DC, RI, NM, ME, VT and the countries of ES, SE, FR, PR, IT, DE, CA, NZ, PL, BR, ZA, NL.
Location: San Diego, CA

Frequently Asked Questions

What product was recalled? ▼

Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797. Recalled by Volcano Corp. Units affected: 14.031 units.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 6, 2022. Severity: Low. Recall number: Z-1301-2022.