Z-2693-2020Class II

Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN...

Name: Z-2693-2020 Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2020-06-08
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2020-06-08 / Terminated

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (sterile, single-use)... on 2020-06-08. FDA classified it as Class II and gives the reason as "Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2693-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-08
Posted: 2020-07-23
Terminated: 2022-05-10
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: 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 Platform intended for the creation of radiofrequency lesions in nervous tissue.
Product code: GXI Probe, Radiofrequency Lesion
Reason for recall: Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
FDA 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 [email protected]. 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: 352 pk
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
Product codes and lots: Lot # BY19L009 BY20A012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2693-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2690-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-23
Z-2691-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-23
Z-2692-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-23
Z-2693-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-23
Z-2694-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-23
Z-2695-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-23

Product code GXI

K181864Class IIPolaris RF Ablation SystemBaylis Medical Company, Inc. / cleared 2019-01-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)