NEUWAVE LK20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00853719006371), received between Mar 13, 2020 and Feb 15, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 15, 2023Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING ABLATION CASE, THE PROBE BROKE (BENT) DURING THE ABLATION CASE INSIDE THE PATIENT. IN ADDITIONAL TO THAT, THE ABLATION ZONE HAS BEEN SHIFTING BACKWARD 2 CM FROM WHAT IT WAS EXPECTED, WHICH MAKE THE ABLATION AREA HIT THE LIVER SURFACE. THE PROCEDURE WAS DELAYED 20 MINUTES. THE PROCEDURE WAS STOPPED AND THE TUMOR WASN'T ABLATED. THE PATIENT EXPERIENCED SEVERE PAIN.

  Patient problems: Pain

  MAUDE report 16381125 ↗
• InjuryDec 2, 2020Break; Break

  IT WAS REPORTED THAT DURING A LIVER ABLATION THE PROBE BROKE WHILE IN THE PATIENTS LIVER. THERE WERE NO PATIENT CONSEQUENCES AND THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10931434 ↗
• InjuryMar 13, 2020Break

  IT WAS REPORTED THAT DURING AN ABLATION THE PROBE BROKE INSIDE THE PATIENT. THE METAL TIP WAS LEFT INSIDE THE LIVER. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9829033 ↗