Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlus...
FDA Device Recall #Z-2718-2015 — Class II — July 22, 2015
Recall Summary
| Recall Number | Z-2718-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 22, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Volcano Corporation |
| Location | Rancho Cordova, CA |
| Product Type | Devices |
| Quantity | 5042 devices |
Product Description
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.
Distribution Pattern
Worldwide Distribution - US (nationwide) Canada, Europe, Saudi Arabia, Iran, Egypt, and Qatar.
Lot / Code Information
Product Code PPLUS20; All lots
Other Recalls from Volcano Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0885-2022 | Class II | SyncVision Systems, Model: 400-0100.10, PN: 300... | Jan 19, 2022 |
| Z-0674-2020 | Class II | Philips Volcano FFR software used in the follow... | Nov 7, 2018 |
| Z-0727-2019 | Class II | Visions PV .035 Digital IVUS Catheter, Catalog ... | Oct 17, 2018 |
| Z-0726-2019 | Class II | Visions PV .035 Digital IVUS Catheter, Catalog ... | Oct 17, 2018 |
| Z-1891-2018 | Class II | Philips Volcano CORE M2 Vascular System, Part #... | Mar 22, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.