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.
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 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, a sterile, single-use medical device intended for the creation of radiofrequency lesions in nervous tissue. The recall involves a specific lot (BY19D020) of the 100mm, 22G cannula, product number AC0019.
The recall was initiated due to a mechanical defect where the probe catches on a lip inside the hub of the cannula, resulting in insertion difficulty. This issue affects the usability of the device during the intended procedure.
The affected products were distributed worldwide, including nationwide in the United States, as well as in Belgium and Australia. Healthcare providers and facilities that have received this specific lot should stop using the product and contact Medtronic for further instructions.
The recalled product
- Product
- Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer…
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 25
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 # BY19D020
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.
See all 6 products in this recall →Related recalls
Same manufacturer · Medtronic Sofamor Danek USA Inc
See all →- HighExpandable spinal cages recalled because they may lose height or collapse
FDA (Devices) · 2025-12-03
- HighGrafton Plus DBM Paste medical device recalled for packaging inspection failure
FDA (Devices) · 2023-11-01
- HighGrafton DBM Demineralized Bone Matrix Recall Due to Sterile Packaging Inspection Failure
FDA (Devices) · 2023-11-01
- ModerateGrafton DMB Matrix bone graft recalled for potential outer pouch defects
FDA (Devices) · 2023-11-01
- HighGrafton DBM Orthoblend Recall Due to Sterile Packaging Inspection Issue
FDA (Devices) · 2023-11-01
Same hazard · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12
Similar recalls
- HighMedtronic Recalls DLP Femoral Arterial Cannulas Due to Connection Issues
FDA (Devices) · 2015-07-08
- SevereMedtronic Recalls Select 3D and CAP Arterial Cannulae Due to Splitting
FDA (Devices) · 2014-02-26
- HighStryker Recalls 210 RF Cannula Units Due to Packaging Error
FDA (Devices) · 2012-08-08
- HighMedtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting
FDA (Devices) · 2014-02-26
- ModerateAbbott Recalls Mislabeled Radiofrequency Cannulas Due to Manufacturing Error
FDA (Devices) · 2020-01-01
- HighMedtronic Recalls Select CAP Arterial Cannulae Due to Body Splitting
FDA (Devices) · 2014-02-26