Z-2221-2025 Class II Ongoing
FDA device recall Z-2221-2025 was initiated by Volcano Corp on June 13, 2025 and is designated Class II. 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 interventio… The recall status is ongoing. Affected quantity: 233,817.
Recall Details
- Product Type
- Devices
- Report Date
- August 6, 2025
- Initiation Date
- June 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 233,817
Product Description
Reason for Recall
Distribution Pattern
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.