Probe, Radiofrequency Lesion
Neurology · 21 CFR 882.4725
Recent MDR events
897 adverse event reports on file
- Intracept EdgeJul 30, 2026OtherMW6000186
- INTRACEPTJul 21, 2026InjuryRelievant Medsystems, Inc.3006630150-2026-05216
- INTRACEPT RF PROBEJul 17, 2026MalfunctionRelievant Medsystems, Inc.3006630150-2026-05057
- NAJul 10, 2026MalfunctionBoston Scientific Neuromodulation Corporation3006630150-2026-04824
- INTRACEPTJul 2, 2026MalfunctionRelievant Medsystems, Inc.3006630150-2026-04584
- INTRACEPTJul 2, 2026MalfunctionRelievant Medsystems, Inc.3006630150-2026-04608
- INTRACEPTJun 30, 2026InjuryRelievant Medsystems, Inc.3006630150-2026-04504
- INTRACEPT RF PROBEJun 26, 2026InjuryRelievant Medsystems, Inc.3006630150-2026-04425
- INTRACEPT RF PROBEJun 26, 2026InjuryRelievant Medsystems, Inc.3006630150-2026-04446
- INTRACEPTJun 19, 2026InjuryRelievant Medsystems, Inc.3006630150-2026-04248
Event type breakdown
Recalls
29 recall events for this product code
- Boston Scientific Neuromodulation CorporationOpen, ClassifiedJul 8, 2026
Intracept Access Instruments, Description/REF:
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.
Z-2694-2026 · View FDA record ↗ - Boston Scientific Neuromodulation CorporationOpen, ClassifiedJun 11, 2026
Boston Scientific CSK Electrodes:
Reusable electrodes may not meet expected performance levels.
Z-2402-2026 · View FDA record ↗ - Boston Scientific Neuromodulation CorporationOpen, ClassifiedJun 11, 2026
Boston Scientific TCN Electrodes:
Reusable electrodes may not meet expected performance levels.
Z-2403-2026 · View FDA record ↗ - Stryker CorporationOpen, ClassifiedJul 3, 2024
This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cann
Expired Products distributed to customers
Z-2261-2024 · View FDA record ↗ - Epimed InternationalTerminatedApr 16, 2020
R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction C
Incorrect expiration date on introduction cannula packaging.
Z-1849-2020 · View FDA record ↗ - Epimed InternationalTerminatedApr 16, 2020
R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Epimed RF Introduction Ca
Incorrect expiration date on introduction cannula packaging.
Z-1850-2020 · View FDA record ↗ - Boston Scientific Neuromodulation CorporationTerminatedApr 10, 2020
Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Me
The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Z-1694-2020 · View FDA record ↗ - Boston Scientific Neuromodulation CorporationTerminatedApr 10, 2020
Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The
The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Z-1695-2020 · View FDA record ↗ - Boston Scientific Neuromodulation CorporationTerminatedApr 10, 2020
Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Me
The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Z-1696-2020 · View FDA record ↗ - Boston Scientific Neuromodulation CorporationTerminatedApr 10, 2020
Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The
The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Z-1697-2020 · View FDA record ↗
Registered firms
177 firms currently registered for this product code
St. Jude Medical, Atrial Fibrillation Division, Inc.
Minnetonka, MN, US
Safemed Medical Devices S.r.o.
Prague Praha, Hlavni Mesto, CZ
Isomedix Operations, Inc.
Temecula, CA, US
Arvato Netherlands B.v.
Heijen Limburg, NL
Arvato Usa Llc
Memphis, TN, US
Boston Scientific Corporation
Coventry, RI, US
Pajunk Gmbh Medizintechnologie
GEISINGEN Baden-Wurttemberg, DE
Nissha Medical Technologies Sas
Cergy Val-d'Oise, FR
Pro-tech Design & Mfg., Inc.
SANTA FE SPRINGS, CA, US
Bausch & Lomb Incorporated
Rochester, NY, US
Armor Plast Ltd
Bangalore Karnataka, IN
Rbc Development Llc Dba Rbc Medical Innovations Dba Vantage Medtech
Lenexa, KS, US
Boston Scientific Neuromodulation Corporation
Valencia, CA, US
Eurofins Inpac Medizintechnik Gmbh
Birkenfeld Baden-Wurttemberg, DE
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Sterigenics U.s., Llc
Salt Lake City, UT, US
Isomedix Operations Inc
GROVEPORT, OH, US
Epimed International, Inc.
Dallas, TX, US
Midwest Sterilization Corp.
JACKSON, MO, US
Diros Technology, Inc.
MARKHAM Ontario, CA
Isomedix Operations Inc
EL PASO, TX, US
Merit Medical Ireland, Ltd
Galway, IE
510(k) clearances
66 clearances for this product code
- ABBOTT MEDICALApr 16, 2026
K253907 · Disposable Radiofrequency Cannula
- Merit Medical Systems, Inc.Feb 13, 2026
K251802 · STAR RF Ablation System
- Neuroone Medical Technologies Corp.Aug 15, 2025
K251243 · OneRF Trigeminal Nerve Radiofrequency Probes
- ABBOTT MEDICALMay 27, 2025
K242841 · Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
- Stryker InstrumentsMay 15, 2025
K250213 · OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
- Shanghai Samedical & Plastic Instruments Co., Ltd.Jan 23, 2025
K241367 · RF Cannula
- Relievant Medsystems, Inc.Oct 26, 2022
K222281 · Intracept Intraosseous Nerve Ablation System
- Relievant Medsystems, Inc.Mar 11, 2022
K213836 · Intracept Intraosseous Nerve Ablation System