Volcano PV — Class II medical device recall Z-1844-2015
Terminated recall by Volcano Corporation, reported 2015-07-01, distributed nationwide. During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in ac
| Recall number | Z-1844-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2015-06-04 |
| Classified | 2015-06-25 |
| Reported by FDA | 2015-07-01 |
| Terminated | 2015-10-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 162 devices |
| Reason classes | labeling |
| Lot numbers | 50002518 |
| Model numbers | 88901 |
Product
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Reason for recall
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
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-1844-2015. 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.