# FDA recall Z-2221-2025

> **Volcano Corp** · Class II · device recall initiated 2025-06-13.

## Product

Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P;  PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.

## Reason for recall

Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of BR, PL, SK, IT, DK, DE, GB, AT, KW, CR, ES, NL, LV, MT, IE, CH, ZA, RO, FI, PR, FR, CA, PA, IL, SE, PT, HR, GR, NZ, HK, TW, MY, TH, MX, AR, PE, AE, BG, AU, JP, ID, RS, CO, SG, BE.

## Key facts

- **Recall number:** Z-2221-2025
- **Recalling firm:** Volcano Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-13
- **Report date:** 2025-08-06

- **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-2221-2025

## Citation

> AI Analytics. FDA recall Z-2221-2025. Retrieved 2026-08-24 from https://api.ai-analytics.org/recall/Z-2221-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*