—#182121

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.

FDA product code: GXI — Probe, Radiofrequency Lesion
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K181864
Affected lot / code info: Lot # BY19L039

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Pl, Memphis, Tennessee 38132-1703

Distribution

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

Timeline

Recall initiated: 2020-06-08
Terminated: 2022-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182121. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.