FDA Device recall Z-2694-2020
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile…
- FDA Device
- Class II
- terminated
- Published 2020-07-29
On 2020-07-29 the FDA classified a Class II recall of Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile… by Medtronic Sofamor Danek Usa, citing insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2694-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-08 |
| Published | 2020-07-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | US |
Product
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - 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
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Identifiers
| code_info | Lot # BY19L039 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2694-2020%22
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