CLASS II Device recall · Reported 29 Jul 2020 · FDA Enforcement Report

Accurian RF Ablation, Cannula pk, Accurian recalled

Medtronic Sofamor Danek USA is recalling Accurian RF Ablation, Cannula pk, Accurian, CS Product Number: AC0016, distributed nationwide in the US. The recall was initiated on 8 Jun 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # BY19L039

Quantity recalled5 pk

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2694-2020
FDA event ID: 85904
Recalling firm: Medtronic Sofamor Danek USA, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 8 Jun 2020
FDA classified: 23 Jul 2020
Reported: 29 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

8 Jun 2020	Recall initiated by company
23 Jul 2020	Classified by FDA	+45 days
29 Jul 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot # BY19L039

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 85904

This product is part of a recall event; the main page for the event is Accurian RF Ablation, Cannula pk, Accurian recalled.

Reported	Class	Recall	Company	Reason	Where
29 Jul 2020	CLASS II	Accurian RF Ablation, Cannula pk, Accurian recalled	Medtronic Sofamor Danek USA	Other	Nationwide
29 Jul 2020	CLASS II	Accurian RF Ablation,Cannula pk, Accurian, SS Product Number: AC0019 recalled	Medtronic Sofamor Danek USA	Other	Nationwide
29 Jul 2020	CLASS II	Accurian RF Ablation, Cannula pk, Accurian recalled	Medtronic Sofamor Danek USA	Other	Nationwide
29 Jul 2020	CLASS II	Accurian RF Ablation, Cannula pk, Accurian recalled	Medtronic Sofamor Danek USA	Other	Nationwide
29 Jul 2020	CLASS II	Accurian RF Ablation, Cannula pk, Accurian recalled	Medtronic Sofamor Danek USA	Other	Nationwide

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