MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of ...
FDA Device Recall #Z-1334-2024 — Class II — January 30, 2024
Recall Summary
| Recall Number | Z-1334-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 30, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Angiodynamics, Inc. |
| Location | Queensbury, NY |
| Product Type | Devices |
| Quantity | 104 units |
Product Description
MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749
Reason for Recall
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
Lot / Code Information
UDI: 15051684022927 UPN: H965457491 Lot Number: 5805056
Other Recalls from Angiodynamics, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1873-2026 | Class II | AccuVu Angiographic Catheter, Straight Flush, N... | Mar 3, 2026 |
| Z-1863-2026 | Class II | Soft-Vu Angiographic Catheter, Berenstein, Non-... | Mar 3, 2026 |
| Z-1872-2026 | Class II | AccuVu Angiographic Catheter, Omni Flush, Non-B... | Mar 3, 2026 |
| Z-1868-2026 | Class II | Soft-Vu Angiographic Catheter, Headhunter (1), ... | Mar 3, 2026 |
| Z-1862-2026 | Class II | Soft-Vu Angiographic Catheter, Kumpe, Non-Braid... | Mar 3, 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.