Medtronic Recalls Accurian RF Ablation Cannulas Due to Insertion Difficulty
Medtronic is recalling Accurian RF Ablation Cannulas because the probes may 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 involves mechanical difficulty during insertion rather than a direct, severe physiological injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling Accurian RF Ablation Cannulas (Product Number: AC0007, GTIN: 20763000153568). The recall involves 481 packages of the 150mm, 18G, 10mm sterile, single-use devices. These products are intended for the creation of radiofrequency lesions in nervous tissue.
The recall was initiated due to reports of insertion difficulty. The issue is caused by the probe catching on a lip inside the hub of the cannula. The affected lots are BY19K031 and BY19L011.
The products were distributed worldwide, including the United States, Belgium, and Australia. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Users should contact Medtronic for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - 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
- 481
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 # BY19K031 BY19L011
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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