NA CUR-101020URecalls & reported problems
Boston Scientific Neuromodulation Corporation · Inject Electrode10cm10mmtip20GEchoCurved · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813250016642), received between Jul 20, 2022 and Oct 3, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device1
- Difficult to Remove1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING THE RADIOFREQUENCY (RF) PROCEDURE AT THE L4 (LUMBAR) AREA THE NEEDLE DETACHED AND WHILE ATTEMPTING TO REMOVE IT THE PHYSICIAN PERFORATED THE AORTA AT THE LEVEL OF THE INFERIOR MESENTERIC ARTERY. AN AORTIC CLAMPING PROCEDURE WAS PERFORMED AND THE PATIENT WAS HOSPITALIZED FOR TWO DAYS. THE RF PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT IS STABLE.
Patient problems: Perforation
MAUDE report 20365269 ↗MalfunctionJul 20, 2022Use of Device Problem; Defective Device; Use of Device Problem; Defective Device
IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION PROCEDURE THE CANNULA BROKE AWAY FROM THE ELECTRODE DURING THE PLACEMENT OF THE PROBE AND BECAME EMBEDDED IN THE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED. THE PATIENT IS RECOVERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15070774 ↗
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
- Intracept RLV 0075Relievant Medsystems, Inc. · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page