NA CC101018Recalls & reported problems
Boston Scientific Neuromodulation Corporation · Cannula,10cm,10mm tip,18G Sharp Straight · Class 2
- 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 00813250012019), received between Jul 15, 2021 and Jul 15, 2021 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT SUFFERED A SEVERE REACTION AT THE SITE OF NEEDLE ENTRY AFTER HAVING A RADIOFREQUENCY LUMBAR NERVE ABLATION PROCEDURE. IT IS UNKNOWN IF THE PATIENT WAS ADMINISTERED MEDICAL INTERVENTION. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION TO DATE DESPITE GOOD FAITH EFFORTS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 12177922 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.