Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty
Medtronic is recalling Accurian RF Ablation Cannulas because the probes catch on a lip inside the hub, causing insertion difficulty.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a mechanical defect causing insertion difficulty, which is a functional issue rather than a direct risk of serious injury or death, fitting the Moderate severity criteria for low-risk or functional defects.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling the Accurian RF Ablation, Cannula pk (Product Number AC0012). The recall involves 352 packages of the sterile, single-use medical device, which is intended for the creation of radiofrequency lesions in nervous tissue.
The recall was initiated due to insertion difficulty. The source text indicates that the probe was catching on a lip inside the hub of the cannula. This defect may impede the proper use of the device during procedures.
The affected products were distributed worldwide, including nationwide in the United States, as well as in Belgium and Australia. The specific lot numbers involved are BY19L009 and BY20A012. Healthcare providers and patients should contact Medtronic for further instructions regarding the return or replacement of these devices.
The recalled product
- 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,
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 352
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # BY19L009 BY20A012
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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