Volcano brand Intravascular Ultrasound — Class II medical device recall Z-2345-2012
Terminated recall by Volcano Corporation, reported 2012-09-19. The display on the system has the potential to change. In house testing eventually identified the unique seque
| Recall number | Z-2345-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2012-08-24 |
| Classified | 2012-09-10 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2014-11-25 |
| Quantity | 1,020 units |
| Model numbers | 435-0602.01, 435-0602.02, 435-0607.01, 435-0607.04 |
Product
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use in imaging of histology.
Reason for recall
The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.
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-2345-2012. 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.