Intracept RLV 0075Recalls & reported problems
Relievant Medsystems, Inc. · Intracept Access Instruments - Additional VB · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00852454006257), received between Nov 11, 2025 and Aug 14, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
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 18, 2026.
Reports received per month
Recalls naming this device
- Apr 22, 2026Class IIOpen, Classified
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 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Fragmentation3
- Nonstandard Device1
Patient problems
- Foreign Body In Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2026Material Fragmentation
Patient problems: Foreign Body In Patient
MAUDE report 50263444 ↗MalfunctionDec 30, 2025Material Fragmentation; Nonstandard Device; Material Fragmentation; Nonstandard Device
IT WAS REPORTED THAT A CURVED CANNULA WAS RETURNED FOR AN UNKNOWN REASON AND ANALYZED. IT WAS FOUND THAT THE CURVED CANNULA SHAFT TIPS WERE SHEARED. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES THAT AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION MUST BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENTS OR PROBE. IT IS UNKNOWN WHETHER ANY DEVICE FRAGMENTS WERE LEFT BEHIND INSIDE THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23931465 ↗MalfunctionNov 11, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT A CURVED CANNULA WAS RETURNED FOR AN UNKNOWN REASON. A VISUAL INSPECTION REVEALED THAT THE CURVED CANNULA SHAFT TIP WAS SHEARED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: Foreign Body In Patient
MAUDE report 23519845 ↗
Other Probe, Radiofrequency Lesion devices
- NA TCN-15Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION2 recalls10 reports
- NA TCN-10-3MBoston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION2 recalls9 reports
- 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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