Recall archive / FDA device enforcement
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797 — FDA record Z-1302-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 13, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
- Reason
- Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
- Classification
- Class III
- Recalling firm
- Volcano Corp
- Quantity
- 7,520 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1302-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 ,; UDI/DI: 00845225002596 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 6, 2022
- Recall initiation date
- May 13, 2022
- Center classification date
- Jun 29, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.