Recall Z-2693-2020 ยท GXI Probe, Radiofrequency Lesion
Medtronic Sofamor Danek USA Inc
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - 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
| Date | Jun 8, 2020 |
| Status | Terminated |
| Reason | Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula. |
| Root cause | Under Investigation by firm |
| Action | Medtronic initiated both a voluntary correction notice pertaining to the labeling for the affected 20G and 22Gs and removal notice pertaining to the affected 18Gs on 10 June 2020. Notice of removal for ACCURIAN RF Cannula (18G, sterile, single-use) state the following action to be taken: 1) Locate and remove the impacted product from normal storage locations. Do not use this product. 2) Complete the enclosed Customer Confirmation Form and return via email to rs.sdmriskmgt@medtronic.com. Please return this form to Medtronic even if you have no affected inventory. 3) As applicable, contact you |
| Quantity | 352 pk |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181864 | Polaris RF Ablation System Baylis Medical Company, Inc., Jan 2, 2019 |