Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicate...
FDA Device Recall #Z-1844-2015 — Class II — June 4, 2015
Recall Summary
| Recall Number | Z-1844-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 4, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Volcano Corporation |
| Location | Rancho Cordova, CA |
| Product Type | Devices |
| Quantity | 162 total devices (included both products) |
Product Description
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
Distribution Pattern
US Nationwide Distribution and one account in Canada.
Lot / Code Information
Product number 88901; lot number 50002518
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-0726-2019 | Class II | Visions PV .035 Digital IVUS Catheter, Catalog ... | Oct 17, 2018 |
| Z-0727-2019 | 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.