Volcano Visions PV — Class III medical device recall Z-1302-2022
Ongoing recall by Volcano Corp, reported 2022-07-06, distributed nationwide. Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
| Recall number | Z-1302-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corp, San Diego, CA, United States |
| Recall initiated | 2022-05-13 |
| Classified | 2022-06-29 |
| Reported by FDA | 2022-07-06 |
| Distributed | Nationwide (US) |
| Quantity | 7,520 units |
| UPC / GTIN / UDI-DI | 00300004856772, 00845225002596 |
| Model numbers | 300004856772/A, 300007367341, 81234 |
Product
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
Reason for recall
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1302-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.