NA RFK-C101020SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00813250012040), received between Nov 11, 2016 and Jul 24, 2024 — classified as 10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A COMPETITORS DEVICE IMPLANTED PRIOR TO THE RADIOFREQUENCY ABLATION (RFA) PROCEDURE. AFTER THE RFA PROCEDURE WAS COMPLETED SUCCESSFULLY, THE PATIENT OBSERVED THE IMPLANTED DEVICE SETTINGS HAD CHANGED UNEXPECTEDLY WITHOUT INTERVENTION. ADDITIONALLY, A WEEK AFTER THE RFA PROCEDURE, THE PATIENT EXPERIENCED SYMPTOMS OF HEADACHE, DIZZINESS, AND DISCOMFORT. THE PAIN PHYSICIAN ASSUMED THESE CHANGES WERE RELATED TO THE RFA PROCEDURE HOWEVER, THE NEUROSURGEON ASSESSED THAT THE IMPLANTED DEVICE APPEARED TO BE FUNCTIONING NORMALLY. DESPITE THIS, THE PATIENT WAS HOSPITALIZED AND UNDERWENT A REVISION PROCEDURE TO REPLACE THE COMPETITORS DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY.

  Patient problems: Discomfort; Dizziness; Headache

  MAUDE report 19822331 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A PATIENT DEVELOPED TEMPORARY WEALS AT THE CANNULA INSERTION SITES A WEEK AFTER THE PROCEDURE. THE PATIENT'S SKIN WAS ITCHY. THE PHYSICIAN SAYS IT APPEARS TO BE TYPE 4 (DELAYED SKIN IMMUNE CELL MEDIATED) HYPERSENSITIVITY RESPONSE. IT IS UNKNOWN IF ANY MEDICAL INTERVENTION WAS PERFORMED. THE PHYSICIAN PREPPED THE PATIENT'S SKIN WITH CHLORAPREP. THE PHYSICIAN IS UNSURE, BUT BELIEVES IT IS POSSIBLE THAT CHLORAPREP COULD BE THE CAUSE OR THE CAUSE COULD BE THE CANNULAS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7403060 ↗
• InjuryMar 13, 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 EXPERIENCED A REACTION THAT WAS INITIALLY ASSESSED TO BE BURN MARKS AT THE PUNCTURE SITE. THE PHYSICIAN FELT THAT MARKS WERE RELATED TO USE OF THE CANNULA, AND LATER ASSESSED THAT HE DOESN'T KNOW THE CAUSE OF THE REACTION BUT BELIEVES IT COULD BE AN ALLERGIC REACTION. THE PATIENT WAS ADMINISTERED A PRESCRIPTION FOR CORTICOID AND THE PATIENT IS DOING FINE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7336176 ↗
• InjuryMar 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A FEW PATIENTS HAVE EXPERIENCED A REACTION AT THE INSERTION POINT WHERE THE CANNULA WAS INSERTED INTO THE PATIENT. THE PUNCTURE SITES WERE RAISED, HAD REDDENED, AND WERE SOMETIMES VERY ITCHY. THE PHYSICIAN DOES NOT KNOW IF THE REACTIONS ARE DEVICE RELATED. IT IS NOT KNOWN IF MEDICAL INTERVENTION WAS PROVIDED. NO FURTHER INFORMATION CAN BE OBTAINED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7331316 ↗
• InjuryOct 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT DURING A LUMBAR PROCEDURE A BLACK THREAD WAS DISCOVERED UPON WITHDRAWING THE STYLET AFTER THE CANNULA WAS PLACED. NO PATIENT HARM WAS RECORDED AND THE CASE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6915608 ↗
• InjuryAug 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A PATIENT EXPERIENCED AN INFECTION IN THEIR BACK AT THE CANNULA SITE FOLLOWING THE PROCEDURE. THE PATIENT'S LOW BACK WAS RED. A DERMATOLOGIST DETERMINED THAT THE PATIENT HAD FOLLICULITIS. THE PATIENT WAS PRESCRIBED ANTIBIOTICS WHICH RESOLVED THE INFECTION IN A FEW DAYS.

  Patient problems: Bacterial Infection; Skin Irritation

  MAUDE report 6801410 ↗
• InjuryJul 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A PATIENT EXPERIENCED ELEVATED, ITCHY RED BUMPS TWO TO TEN DAYS AFTER THE PROCEDURE. THE BUMPS APPEARED TO BE SIMILAR TO MOSQUITO BITES. IT IS NOT KNOWN IF TREATMENT WAS PROVIDED. NO FURTHER INFORMATION CAN BE OBTAINED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 6748488 ↗
• InjuryJul 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A PATIENT EXPERIENCED ELEVATED, ITCHY RED BUMPS TWO TO TEN DAYS AFTER THE PROCEDURE. THE BUMPS APPEARED TO BE SIMILAR TO MOSQUITO BITES. IT WAS DETERMINED THAT THE PATIENT HAD AN ALLERGIC REACTION. THE PATIENT'S SYMPTOMS HAVE RESOLVED. IT IS NOT KNOWN IF TREATMENT WAS PROVIDED. NO FURTHER INFORMATION CAN BE OBTAINED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 6746993 ↗
• InjuryNov 11, 2016Adverse Event Without Identified Device or Use Problem

  THE FACILITY REPORTED THAT THE PATIENT EXHIBITED 3 BURNS ON HER BACK. SHE FEELS ITCHY AND HAS THE RED SPOTS AT THE LOCATION. SHE IS CURRENTLY DOING OK BUT WILL KEEP DOCUMENTATION OF HERSELF.

  Patient problems: Burn(s); Erythema; Itching Sensation

  MAUDE report 6095405 ↗
• InjuryNov 11, 2016Adverse Event Without Identified Device or Use Problem

  THE FACILITY REPORTED THAT THE PATIENT EXHIBITED BURN ON HER BACK FOLLOWING FEW DAYS AFTER THE ABLATION. THE LOCATION WAS ON HER BACK. ACCORDING TO THE PHYSICIAN ASSISTANT, THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Burn(s)

  MAUDE report 6095391 ↗