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NA RFK-C101018SRecalls & reported problems

Boston Scientific Neuromodulation Corporation · Cannula, 10cm,10mm tip,18G Sharp Curved · Class 2

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 00813250012101), received between Apr 3, 2018 and May 29, 2018 — classified as 2 injuries.

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 Problem2

Patient problems

  • Hypersensitivity/Allergic reaction2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A REPORT WAS RECEIVED THAT ONE WEEK FOLLOWING AN RF ABLATION PROCEDURE, A PATIENT EXPERIENCED 8 SKIN TAGS ON HIS BACK AT THE INSERTION SITE OF THE NEEDLES. THE PHYSICIAN ASSESSED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION, IT IS UNKNOWN IF TREATMENT WAS PROVIDED FOR THE SYMPTOMS. AN ALLERGY TEST WAS PERFORMED BUT THE RESULTS WILL NOT BE PROVIDED. THE PATIENT'S STATUS IS STABLE.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 7549404 ↗
  • InjuryApr 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A REPORT WAS RECEIVED THAT AFTER A RADIOFREQUENCY PROCEDURE THE PATIENT NOTICED THAT HE HAD SIX SKIN TAGS ON HIS BACK. IT WAS NOTED THAT EACH TAG CORRESPONDED TO EACH NEEDLE INCISION, THREE PER SIDE, SO THE PHYSICIAN ASSOCIATED THE EVENT WITH THE CANNULA. THE TAGS WERE RED, ROUND SHAPED, AND LESS THAN 2 CM. DURING THE PROCEDURE IT WAS NOTED THAT THE PHYSICIAN INJECTED SALINE THROUGH THE CANNULAS. THEY DID NOT USE ANY SKIN PREPARATION OR DRESSING THAT COULD HAVE GOTTEN INTO THE PUNCTURE SITE. THE PHYSICIAN DOES NOT KNOW THE CAUSE OF THE REACTION BUT BELIEVE IT COULD BE AN ALLERGIC REACTION. THE PATIENT WAS ADMINISTERED PRESCRIPTION CORTICOID MEDICATION. THE PATIENT IS STABLE.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 7393829 ↗

Other GENERATOR, LESION, RADIOFREQUENCY devices

All GENERATOR, LESION, RADIOFREQUENCY devices →

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