NA SL-C1510-20Recalls & reported problems
St. Jude Medical, Inc. · SL Radiofrequency Cannula - Curved · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067028259), received between Dec 3, 2020 and Mar 4, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Biocompatibility” (1 report).
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
Most reported problems
Device problems
- Biocompatibility1
- Material Separation1
Patient problems
- Hypersensitivity/Allergic reaction1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2024Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITH A RED RING AROUND THE NEEDLE INSERTION SITE FOLLOWING A RF PROCEDURE. THE HEALTHCARE PROVIDED DETERMINED IT WAS AN UNKNOWN ALLERGIC REACTION TO SILICONE. THE REPORTED RED RING HAS RESOLVED ON ITS OWN.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18828044 ↗InjuryDec 3, 2020Material Separation; Material Separation
DURING THE PROCEDURE, TWO RF CANNULAS WERE USED FOR A BILATERAL INJECTION TO THE SIJ. WHILE REMOVING THE RF CANNULA, PART OF THE ISOLATION OF ONE OF THE CANNULAS WAS RIPPED AND REMAINED IN THE BODY OF THE PATIENT. THE PIECE WAS UNABLE TO BE FELT THROUGH THE SKIN AND IT WAS THOUGHT TO HAVE BEEN WITHIN THE DEEPER TISSUE. THE PATIENT WAS DISCHARGED IN STABLE CONDITION WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10941306 ↗
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
- 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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