FDA Device recall Z-2718-2015
Volcano Pioneer Plus Re-Entry Catheter
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of Volcano Pioneer Plus Re-Entry Catheter by Volcano, citing 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 Cath….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2718-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-22 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Volcano |
| Distribution | US |
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
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.
Identifiers
| code_info | Product Code PPLUS20; All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Volcano
- Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
FDA Device · Class II · 2026-10-07 · Volcano - Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P
FDA Device · Class II · 2025-08-06 · Volcano - Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano - Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano - Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
FDA Device · Class II · 2022-06-22 · Volcano
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2718-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.