Class 2 Device Recall Accurian RF Cannula

• Date Initiated by Firm: June 08, 2020
• Create Date: July 23, 2020
• Recall Status: Terminated on May 10, 2022
• Recall Number: Z-2692-2020
• Recall Event ID: 85904
• 510(K)Number: K181864
• Product Classification: Probe, radiofrequency lesion - Product Code GXI
• Product: 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.
• Code Information: Lot # BY19L001 BY19L022 BY19L044 BY19M001 BY19M002 BY20A022 BY20B009
• Recalling Firm/ Manufacturer: Medtronic Sofamor Danek USA Inc; 1800 Pyramid Pl; Memphis TN 38132-1703
• For Additional Information Contact: Eric Epperson; 901-344-1435
• Manufacturer Reason for Recall: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
• FDA Determined 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 your Medtronic Sales Representative to coordinate the return and replacement of affected product. 4) Transmission of this Recall notification letter: a. This notification needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. b. Please transfer this notice to other organizations on which this action has an impact. c. Please maintain a copy of this notice in your records. Safety Notification ACCURIAN RF Cannula (20G & 22G sterile, single-use) state the following action to be taken: Accurian RF cannula lot numbers identified may be used with adherence to the following mitigation: 1) In addition to following instructions within product IFU, the probe should be threaded straight into the center of the hub of the cannula. Do not insert a probe at an angle into the cannula. 2)If the probe catches in the cannula during insertion, remove and reinsert by threading straight into the center of the hub of the cannula.
• Quantity in Commerce: 2415 pk
• Distribution: Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GXI and Original Applicant = Baylis Medical Company Inc.