RadiOpaque Radiofrequency Cannula PMF22-100-10CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193493986446), received between Feb 2, 2023 and Jun 30, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJun 30, 2023Break; Break

  IT WAS REPORTED THAT POST RF PROCEDURE "THE CANNULA APPEARS TO HAVE LEFT A PIECE BEHIND" AND WAS RETAINED INSIDE OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17237482 ↗
• MalfunctionFeb 2, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THE "MARKER APPEARED TO COME OFF AS CANNULA WAS ADVANCED IN POSTERIOR SOFT TISSUES. NO UNUSUAL MANIPULATION OF NEEDLE OCCURRED. PROCEDURE NOT ABORTED AS TESTING WAS FINE AND PLACEMENT APPEARED OPTIMAL. THE PROBE WAS NOT PLACED UNTIL AFTER CANNULA WAS PLACED." THE PATIENT WAS NOT INTERESTED IN HAVING THE RICE-SIZED FRAGMENT REMOVED BECAUSE IT WAS NOT PAINFUL. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16283860 ↗

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