RadiOpaque Radiofrequency Cannula PMF20-100-10CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193493986347), received between Jan 12, 2021 and Sep 20, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

• MalfunctionSep 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RADIOPAQUE COLLAR ON THE STANDARD RADIOFREQUENCY PROBE CANNULA WAS RETAINED IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED 27-AUG-2021 INDICATED THE RETAINED COMPONENT WAS THE "'COLLAR' OF THE CANNULA AT THE DISTAL MOST MARGIN OF THE SHIELDED BLACK COMPONENT OF THE CANNULA WHERE THE SHIELDED PORTION MEETS THE UNSHIELDED PORTION." PROCEDURE WAS "BILATERAL LUMBAR L3, L4 AND L5 MEDIAL BRANCH RADIOFREQUENCY ABLATION." THE PROBE COLLAR IS LOCATED ADJACENT TO THE RIGHT L5 SUPERIOR ARTICULAR PROCESS. A CT LUMBAR SPINE WAS PERFORMED. NEUROSURGICAL CONSULTATION WAS PERFORMED WITHOUT ANY FURTHER INTERVENTION RECOMMENDED. NO APPARENT PATIENT ADVERSE EFFECTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 12494737 ↗
• MalfunctionJan 12, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE RADIOPAQUE PORTION OF THE CANNULA BROKE OFF DURING THE PROCEDURE AND EMBEDDED INTO THE SOFT TISSUE OF THE CERVICAL REGION. ADDITIONAL INFORMATION RECEIVED 29-DEC-2020 FROM THE PHYSICIAN INDICATED "RADIOPAQUE INDICATOR AT THE BASE OF THE ACTIVE TIP WAS NOTED TO BE DISENGAGED FROM THE CANNULA DURING PLACEMENT/MANIPULATION OF THE TIP TO GET IT IN THE RIGHT POSITION. THE STYLET WAS ENGAGED DURING MANIPULATION. RADIOPAQUE DOT COULD BE SEEN ON X-RAY DURING THE PROCEDURE THAT WAS LEFT BEHIND ALONG THE LATERAL CERVICAL WAIST." COMPONENT REPORTED TO STILL BE IN PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11154981 ↗

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