Medtronic Sofamor Danek USA Inc recalls Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Pr…

Recall date

June 8, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2692-2020

FDA classification

Class II

Brand / firm

Medtronic Sofamor Danek USA Inc

Sold / distributed

Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.

Why it was recalled

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - 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.