Recall record at a glance
| Official record | Z-2221-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Volcano Corp |
| Report date | Aug 6, 2025 |
| Recall initiation date | Jun 13, 2025 |
| Quantity | 233,817 |
| Location | San Diego, CA, United States |
Official product description
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.
Why the product was recalled
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 information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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