Volcano Corp: Medical Device Recall in 2022 - (Recall #: Z-1301-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: May 13, 2022

Date Posted: July 6, 2022

Recall Number: Z-1301-2022

Event ID: 90252

Reason for Recall:

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

Status: Ongoing

Product Quantity: 14.031 units

Code Information:

All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated