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: AC0009, 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
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-2692-2020
- 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
- Sterility
- 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
Questions about this recall
Is Accurian RF Ablation, Cannula pk, Accurian, CS Product Number: AC0009 recalled?
Yes. Medtronic Sofamor Danek USA recalled Accurian RF Ablation, Cannula pk, Accurian, CS Product Number: AC0009 on 8 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2692-2020.
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 # BY19L001 BY19L022 BY19L044 BY19M001 BY19M002 BY20A022 BY20B009
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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