Certus® 140 2.45 GHz Ablation System (REF LK15cm - 15ga)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853719006067), received between Mar 7, 2017 and Mar 7, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2017Migration or Expulsion of Device; Device Operates Differently Than Expected

  A (B)(6) MALE PATIENT. PHYSICIAN USED TWO PROBES TO ABLATE A LESION IN THE PATIENT'S LIVER. PHYSICIAN PLACED PR PROBE INTO PORTION OF THE LESION DEEPER IN PATIENT'S LIVER AND PLACED AN LK IN THE PORTION OF THE LESION CLOSER TO THE PATIENT'S SKIN. BOTH PROBES WERE PLACED IN TISSU-LOC AND CT IMAGING WAS USED TO CONFIRM PROPER PROBE PLACEMENT. THE LK PROBE POWER WAS SET TO 90W AND 7 MINUTES. THE PR PROBE WAS SET TO 65W FOR 7 MINUTES. THE ABLATION WAS INITIATED AND THE PHYSICIAN HELD THE PROBES IN PLACE DURING THE FIRST ~50 SECONDS OF THE ABLATION, AS RECOMMENDED IN THE USER MANUAL. AFTER THE FIRST ~50 SECONDS, THE PHYSICIAN USED ULTRASOUND TO MONITOR THE ABLATION ZONE, WHICH REQUIRES THE ULTRA SOUND PROBE TO BE PLACED ON THE PATIENTS SKIN AND MANIPULATED. THE SITE PROTOCOL CALLED FOR SEVERAL CT SCANS TO BE TAKEN DURING THE PROCEDURE, SO THE HOSPITAL PERSONNEL LEFT THE CT SUITE DURING THE LATER STAGES OF ABLATION. THE CT BED/PATIENT ENTERED THE CT GANTRY SEVERAL TIMES, BUT NO IMAGES WERE AVAILABLE ON THE CT REVIEW STATION. THE ABLATION COMPLETED AT 7 MINUTES. UPON RE-ENTERING THE PROCEDURE ROOM, IT WAS OBSERVED THAT THE PATIENT HAD A SKIN BURN AT THE SITE OF THE LK PROBE INSERTION. THE

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 6385109 ↗