Recall archive / FDA device enforcement
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102 — FDA record Z-0901-2022
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 Jan 24, 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
- IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
- Reason
- Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.
- Classification
- Class III
- Recalling firm
- Volcano Corp
- Quantity
- 47
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0901-2022
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 MM-TSM units, Device Identifier (DI): 00845225012915 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 20, 2022
- Recall initiation date
- Jan 24, 2022
- Center classification date
- Apr 8, 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.