Intracept FG 0046Recalls & reported problems
Relievant Medsystems, Inc. · Intracept Access Instruments - Additional Level · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00852454006035), received between Jan 26, 2024 and Jan 26, 2024 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PHYSICIAN WAS ADVANCING THE CURVED CANNULA AND UPON EXTRACTING REALIZED THE TIP HAD SPLIT IN HALF. PHYSICIAN ATTEMPTED ACCESS AGAIN ON THE OTHER VERTEBRAL BODY WITH A NEW CURVED CANNULA, WHICH ALSO SPLIT IN HALF AND THIS LEVEL WAS NOT ABLE TO BE ABLATED. THE PHYSICIAN WAS UNABLE TO EXTRACT THE SECOND SPLIT CURVED CANNULA THE FROM THE BONE AND ENDED UP BREAKING THE PEEK MATERIAL OFF. THE PHYSICIAN HAD TO DISSECT DOWN TO REMOVE AS MUCH OF THE MATERIAL AS POSSIBLE. PATIENT IS DOING WELL. AT 2 WEEK FOLLOW UP, THE PATIENT DID NOT HAVE ANY TENDERNESS OVER THE RIGHT SIDE WHERE THE CURVED CANNULA WAS DISSECTED.
Patient problems: Foreign Body In Patient
MAUDE report 18592361 ↗
Other Probe, Radiofrequency Lesion devices
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- NA CSK-TC10Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION1 recall1 death58 reports
- NA CLASSICSt. Jude Medical, Inc. · PROBE, RADIOFREQUENCY LESION1 recall40 reports
- Intracept RLV 0055Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall30 reports
- Intracept RLV 0045Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall1 death23 reports
- Intracept RLV0065Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall14 reports
- NA CSK-TC5Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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