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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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