Accurian RF Ablation — Class II medical device recall Z-2695-2020
Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2020-07-29, distributed nationwide. Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
| Recall number | Z-2695-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2020-06-08 |
| Classified | 2020-07-23 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2022-05-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE |
| Quantity | 25 pk |
| UPC / GTIN / UDI-DI | 20763000153667 |
| Lot numbers | BY19D020 |
Product
Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2695-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.