Volcano Pioneer Plus Re-Entry Catheter — Class II medical device recall Z-2718-2015
Terminated recall by Volcano Corporation, reported 2015-09-09, distributed nationwide. Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter sh
| Recall number | Z-2718-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2015-07-22 |
| Classified | 2015-09-02 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2016-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, EG, IR, QA, SA |
| Quantity | 5,042 devices |
Product
Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature.
Reason for recall
Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters.
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-2718-2015. 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.