IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended t...
FDA Device Recall #Z-1687-2025 — Class II — March 24, 2025
Recall Summary
| Recall Number | Z-1687-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 24, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Boston Scientific Corporation |
| Location | Maple Grove, MN |
| Product Type | Devices |
| Quantity | 31 units |
Product Description
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
Reason for Recall
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
Distribution Pattern
Nationwide
Lot / Code Information
GTIN 00191506032685, Batch Numbers: 33996437, 33996438, 34295231, 34295232, 34392272, 34392273, 34392274, 34564921.
Other Recalls from Boston Scientific Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2049-2026 | Class II | LUX-Dx II Plus, Arrythmia detector and alarm, M... | Mar 30, 2026 |
| Z-2048-2026 | Class II | LUX-DX II, Arrythmia detector and alarm, Model ... | Mar 30, 2026 |
| Z-1770-2026 | Class I | Boston Scientific Pacemaker, Implantable Pulse ... | Mar 19, 2026 |
| Z-1771-2026 | Class I | Boston Scientific Cardiac Resynchronization The... | Mar 19, 2026 |
| Z-1551-2026 | Class II | EndoVive Safety PEG Kit; Outer Box Material Nu... | Feb 10, 2026 |
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.