Medtronic Accurian RF Ablation Cannula Recalled for Insertion Difficulty
Medtronic is recalling Accurian RF Ablation Cannulas because the probe catches 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 (insertion difficulty) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling the Accurian RF Ablation, Cannula (Product Number AC0005). The recall involves 778 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. Specifically, the probe was catching on a lip inside the hub of the cannula. This mechanical issue affects the usability of the device during the procedure.
The affected lots are BY19L007, BY19M013, BY20A014, and BY20C011. The products were distributed worldwide, including in the United States, Belgium, and Australia. Users should stop using the affected devices and contact Medtronic for further instructions.
The recalled product
- Product
- Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - 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, a
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 778
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 # BY19L007 BY19M013 BY20A014 BY20C011
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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