Medtronic Accurian RF Ablation Cannula Recall for Insertion Difficulty
Medtronic is recalling Accurian RF Ablation Cannulas because the probe 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, and the hazard is a mechanical insertion difficulty without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling Accurian RF Ablation Cannulas (Product Number AC0009) due to a design issue that causes insertion difficulty. The recall covers 2,415 packages distributed worldwide, including the United States, Belgium, and Australia.
The specific defect involves the probe catching on a lip inside the hub of the cannula. This product is a sterile, single-use medical device intended for the creation of radiofrequency lesions in nervous tissue.
The recall includes specific lot numbers: BY19L001, BY19L022, BY19L044, BY19M001, BY19M002, BY20A022, and BY20B009. Healthcare providers and consumers should stop using these devices and contact Medtronic for further instructions.
The recalled product
- Product
- 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,
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — RF Ablation
- Hazard
- Affected units
- 2,415
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 # BY19L001 BY19L022 BY19L044 BY19M001 BY19M002 BY20A022 BY20B009
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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