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, and the issue is a mechanical defect (insertion difficulty) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling the Accurian RF Ablation, Cannula pk (Product Number: AC0016, GTIN/UPN: 20763000153674). The recall involves Lot # BY19L039, which was distributed worldwide, including the United States, Belgium, and Australia.
The recall was initiated due to insertion difficulty with the probes. Specifically, the probe was catching on a lip inside the hub of the cannula. The product is a sterile, single-use device intended for the creation of radiofrequency lesions in nervous tissue.
Healthcare providers and patients who have used or possess this specific lot of the Accurian RF Ablation Cannula should contact Medtronic for further instructions on how to proceed.
The recalled product
- Product
- 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, a
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 5
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 # BY19L039
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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