RadiOpaque Radiofrequency Cannula PMF21-100-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00193493986422), received between Oct 5, 2023 and Jan 2, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K972846); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED, ¿DURING FOLLOW UP PROCEDURE IN (B)(6) 2024, A RADIOFREQUENCY ABLATION CANNULA TIP WAS FOUND TO BE BROKEN OFF IN THE PATIENT NECK FROM THE PREVIOUS YEAR PROCEDURE. IT WOULD HAVE BROKEN OFF IN (B)(6). ISSUE WAS NOT DISCOVERED AT THE TIME OF EVENT. CLINICIAN THINK NO HARM TO THE PATIENT. UNABLE TO RETRIEVE THE TIP. IMPACT OF INCIDENT: NOTHING HARMFUL AT THE TIME.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 21054797 ↗
• MalfunctionNov 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, ¿THE RADIOPAQUE BAND FELL OFF DURING PROCEDURE AND RETAINED IN PATIENT. AS IT IS IMPOSSIBLE TO RETRIEVE THE BAND, THIS SIGNIFICANTLY INCREASED RISK TO THE PATIENTS.¿ PER ADDITIONAL INFORMATION RECEIVED ON 18OCT2023, ¿DURING THE COURSE OF THE PROCEDURE, WHEN THE 21-GAUGE 10 CM NEEDLE WAS BEING ADVANCED TOWARDS THE TARGET TISSUE UNDER FLUOROSCOPIC GUIDANCE, IT WAS IMMEDIATELY RECOGNIZED THAT THE TINY 0.1 CM RADIOPAQUE MARKER BECAME DETACHED FROM THE NEEDLE TIP. REMOVED THE DEFECTIVE NEEDLE AND ADVANCED A NEW 21-GAUGE 10 CM NEEDLE TOWARDS THE TARGET SUPERFICIAL TO THE LATERAL MASS OF C5. IT IS NOT POSSIBLE TO REMOVE THIS VERY SMALL RADIOPAQUE FOREIGN BODY FROM PATIENT¿S PARASPINAL SOFT TISSUES. THE GREATEST RISK ASSOCIATED WITH THIS WOULD BE A FOREIGN BODY RELATED INFECTION. EVERY POSSIBLE PRECAUTION IS ROUTINELY MADE TO PREVENT INFECTION.¿ THE PROCEDURE BEING PERFORMED WAS CERVICAL RADIOFREQUENCY ABLATION.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 18051829 ↗
• MalfunctionOct 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THAT DURING A CERVICAL RADIOFREQUENCY ABLATION (RFA) PROCEDURE WITH A STANDARD 21-GAUGE 10 CM CANNULA, THE RADIOPAQUE BAND AT THE TIP OF THE CANNULA BECAME DISLODGED IN THE PATIENT'S TISSUES DURING THE PROCEDURE. IT WAS NOTICED INTRAPROCEDURE, BUT ¿ASSUMED EXTERNAL AS HAD NEVER SEEN THIS BEFORE OR KNOWN TO BE AN ISSUE¿. THE PROCEDURE WAS PERFORMED AND FINISHED OTHERWISE UNEVENTFULLY. THE CANNULA, ON VISUAL INSPECTION, LOOKED ENTIRELY NORMAL, BUT UNDER FLUOROSCOPY, THE CANNULA NO LONGER HAD THE 1 MM RADIOPAQUE BAND. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17881377 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972846. One submission often covers many models, so check the product and lot details in each record.

• Z-0850-2014 · Oct 29, 2013 · Terminated
  Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used
• Z-0879-2013 · Oct 4, 2012 · Terminated
  BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then pla