Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN...
FDA Device Recall #Z-2690-2020 — Class II — June 8, 2020
Recall Summary
| Recall Number | Z-2690-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 8, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Sofamor Danek USA Inc |
| Location | Memphis, TN |
| Product Type | Devices |
| Quantity | 778 pk |
Product Description
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.
Reason for Recall
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
Lot / Code Information
Lot # BY19L007 BY19M013 BY20A014 BY20C011
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| Z-0580-2026 | Class II | Catalyft PL & PL40 Expandable Interbody System ... | Sep 16, 2025 |
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| Z-0166-2024 | Class II | Grafton Plus DBM Paste, Model Numbers: a) T4500... | Sep 26, 2023 |
| Z-0167-2024 | Class II | Grafton DBM Putty, Model Numbers: a) T43102, b)... | Sep 26, 2023 |
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.