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NA CC10521Recalls & reported problems

Boston Scientific Neuromodulation Corporation · Cannula, 10cm,5mm tip,21G 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 00813250012477), received between Oct 12, 2017 and Oct 12, 2017 — 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
  • Swelling1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A REPORT WAS RECEIVED THAT FOLLOWING A RADIOFREQUENCY TREATMENT, THE PATIENT EXPERIENCED A LOCATION REACTION ON THE SITE OF THE PUNCTURE. THE PHYSICIAN NOTED THERE WAS RED SWELLING AROUND THE TWO POINTS OF INSERTION. THE PHYSICIAN REPORTED THAT SHE WAS NOT SURE THAT THE REACTION HAD TO DO WITH THE NEEDLES, AND ASSESSED THAT IT COULD HAVE ALSO BEEN DUE TO THE LOCAL ANESTHETIC. IT IS NOT KNOWN IF THE PATIENT WAS ADMINISTERED ANY MEDICAL TREATMENT FOR THE ALLERGIC REACTION. THE PATIENT WILL UNDERGO SKIN TESTING.

    Patient problems: Hypersensitivity/Allergic reaction; Swelling

    MAUDE report 6946636 ↗

Other PROBE, RADIOFREQUENCY LESION devices

All PROBE, RADIOFREQUENCY LESION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.