# FDA recall Z-1301-2022

> **Volcano Corp** · Class III · device recall initiated 2022-05-13.

## Product

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

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-1301-2022
- **Recalling firm:** Volcano Corp
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-13
- **Report date:** 2022-07-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1301-2022

## Citation

> AI Analytics. FDA recall Z-1301-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1301-2022. Source: US FDA. Licensed CC0.

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