NEUWAVE NWSR25Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00853719006432), received between Nov 2, 2017 and Aug 19, 2025 — classified as 3 injuries, 2 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LIVER ABLATION PROCEDURE THE DEVICE CAUSED SKIN BURN TO THE PATIENT.

  Patient problems: Burn(s); Partial thickness (Second Degree) Burn

  MAUDE report 22840927 ↗
• InjuryJun 24, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: MINIMALLY INVASIVE MICROWAVE ABLATION PROVIDES EXCELLENT LONG-TERM OUTCOMES FOR OTHERWISE INACCESSIBLE HEPATOCELLULAR CANCER AUTHORS: ARIELLA M. ALTMAN MD, MS1, ALEXANDRIA COUGHLAN MD1, DIP M. SHUKLA BS1 , ROBBEN SCHAT MD2, BENJAMIN SPILSETH MD2, SCHELOMO MARMOR MPH, PHD1, JANE Y. C. HUI MD, MS1, TODD M. TUTTLE MD, MS1, ERIC H. JENSEN MD1 CITATION CITE:J SURG ONCOL. 2020;121:1218¿1224. DOI: 10.1002/JSO.25924 THE AIM OF THIS STUDY IS TO EVALUATE THE LONG-TERM ONCOLOGIC OUTCOMES OF LAPAROSCOPIC MWA FOR THESE OTHERWISE INACCESSIBLE LESIONS. OF PARTICULAR INTEREST WAS EVALUATING THE ABILITY TO TARGET THESE PREVIOUSLY INACCESSIBLE LESIONS SUCCESSFULLY AND TO DETERMINE THE RISK OF LOCAL RECURRENCE AT THE SITE OF ABLATION. A RETROSPECTIVE CHART REVIEW WAS PERFORMED ON ALL PATIENTS WHO UNDERWENT SURGICAL MWA FOR HEPATOCELLULAR CARCINOMA BETWEEN 2009 AND 2017.THIRTY-THREE PATIENTS WERE IDENTIFIED. THE MEDIAN AGE OF THE COHORT WAS 62 YEARS OLD (INTERQUARTILE RANGE [IQR] 57-67). TWENTY-FIVE (76%) PATIENTS WERE MALE AND 23 (70%) PATIENTS WERE WHITE. HEPATITIS C WAS THE MOST COMMON PRIMARY LIVER DISEASE (22 PATIENTS, 67%) AND 32 PATIENTS HAD UNDERLYING

  Patient problems: Cancer; Obstruction/Occlusion; Pain; Urinary Retention

  MAUDE report 12060667 ↗
• MalfunctionMay 14, 2021Break; Break

  IT WAS REPORTED THAT DURING A LIVER ABLATION. RESECTION THE PROBE BROKE OFF INSIDE THE PATIENT. THE PROBE AND ALL OF THE PIECES WERE LOCATED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONVERTED TO OPEN AND WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825485 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LIVER ABLATION PROCEDURE THAT AT THE END OF THE PROCEDURE IT WAS NOTICED THAT THE PATIENT RECEIVED A ¿BURN¿ ON THEIR SKIN. SALES REP WAS IN THE CASE AND THE ONLY UNUSUAL THING SHE NOTICED WAS THAT DURING THE THIRD ABLATION THAT THE SHAFT FROSTED UP AND IT LOOKED LIKE THERE WAS A LITTLE BIT OF ¿ICE¿ ON IT. REP STATED THAT SHE NOTICED A BIT OF FROST ON THE SHAFT DURING ALL THREE ABLATIONS BUT NO ¿ICE¿ TILL THE THIRD. FIRST ABLATION WAS AT 140 W FOR THREE AND A HALF MINUTES. SECOND ABLATION FOR FIVE MINUTES AT 140 W. SURGEON DECIDED TO DO A THIRD ABLATION AT 140 W FOR FIVE MINUTES. WITH A MINUTE TO TWO MINIATURES BETWEEN EACH ABLATION. CALL HOME HAS BEEN SENT.

  Patient problems: Burn(s)

  MAUDE report 11825345 ↗
• MalfunctionNov 2, 2017Break

  IT WAS REPORTED THAT DURING A LIVER RESECTION PROCEDURE, THE SR25 PROBE WAS PLACED IN TO SMALL OF AN ULTRASOUND PROBE GUIDANCE TOOL AND BROKE THE TIP OFF PROBE. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6996536 ↗