NEUWAVE LK15XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00853719006364), received between Jun 15, 2022 and Dec 7, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE THE TIP OF THE PROBE BROKE. IT WAS EASILY RETRIEVED AND A NEW PROBE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932363 ↗
• InjuryJun 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE USING A LK15XT PROBE, AFTER THE ABLATION WAS COMPLETED, ON THE CT, THERE WAS SUBCUTANEOUS EMPHYSEMA. IT WAS NOT PRESENT ON THE PREABLATION SCAN HOWEVER IT SHOWED UP ON THE 5 AND 10 MINUTE ABLATION SCAN. THE PROCEDURE WAS COMPLETED AND THERE WAS NO COMPLICATION KNOWN TO THE PATIENT OTHER THAN SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14698314 ↗