Medtronic Sofamor Danek USA Inc recalls Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm
Recalled Product
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - 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.
Hazard / Issue
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Issued by
FDA
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