NEUWAVE PR20XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00853719006425), received between Dec 16, 2019 and Apr 20, 2026 — classified as 22 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Break; Excessive Heating

  IT WAS REPORTED THAT DURING AN OPEN DISTAL PANCREATECTOMY WITH SPLENECTOMY, ULTRASOUND, OPEN CHOLECYSTECTOMY, DIAPHRAGM RESECTION, PARTIAL LEFT ADRENALECTOMY, LEFT LATERAL SECTIONECTOMY, AND MICROWAVE ABLATION OF THE LIVER THE PROBE GOT TOO HOT AND THE TIP BROKE OFF IN THE LIVER. THE TIP WAS RETRIEVED FROM THE PATIENT AND THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927490 ↗
• MalfunctionApr 20, 2026Break; Excessive Heating

  IT WAS REPORTED THAT DURING AN OPEN DISTAL PANCREATECTOMY WITH SPLENECTOMY, ULTRASOUND, OPEN CHOLECYSTECTOMY, DIAPHRAGM RESECTION, PARTIAL LEFT ADRENALECTOMY, LEFT LATERAL SECTIONECTOMY, AND MICROWAVE ABLATION OF THE LIVER THE PROBE GOT TOO HOT AND THE TIP BROKE OFF IN THE LIVER. THE TIP WAS RETRIEVED FROM THE PATIENT AND THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927379 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE ABLATION CLINICAL TRIAL (B)(4) THE PATIENT EXPERIENCED LOW-ABUNDANCE PNEUMOTHORAX. THE PATIENT WAS TREATED WITH OXYGEN THERAPY AT 3L/MIN. THE PATIENT HAS RECOVERED. THERE IS AN UNLIKELY RELATIONSHIP WITH THE DEVICE AND A CAUSAL RELATIONSHIP WITH THE PROCEDURE.

  Patient problems: Insufficient Information; Pneumothorax; Restenosis

  MAUDE report 22166077 ↗
• MalfunctionMay 14, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN ABLATION THE NEEDLE CONNECTED 1 TIME: ERROR MESSAGE, THEN RECONNECTED: OK. TEST: OK. IMPLANTATION IN PATIENT - STICK: OK; THEN NO FUNCTIONAL TREATMENT PROTOCOL. NEEDLE RECONNECTED TO ANOTHER CHANNEL: STILL NOT OPERATIONAL. CHANGE FOR A NEW NEEDLE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021558 ↗
• InjuryJan 31, 2025Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN ABLATION CASE, THE TIP BROKE OFF IN THE PATIENT. THE TIP WAS RETRIEVED. INTERVENTION WAS NOT NEEDED TO LOCATE THE TIP. CASE WAS COMPLETED. NO PATIENT HARM WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21283896 ↗
• InjuryMay 24, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE ABLATION THE PROBE BROKE IN THE PATIENT AND HAD TO BE SURGICALLY REMOVED. NO PATIENT HARM REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19390742 ↗
• InjuryApr 29, 2024Connection Problem; Protective Measures Problem; Connection Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING AN ABLATION A PROBE WAS CONNECTED TO CHANNEL 2, DID THE TEST SUCCESSFULLY IN WATER. THE PROBE WAS IN THE PATIENT. BEFORE PRESSING THE TISSUE LOC BUTTON, THE TEST BUTTON WAS NO LONGER ¿CHECKED¿. THE TEST WAS REDONE WITH THE PROBE IN THE PATIENT BUT THEN COULDN'T REDO THE TEST. THE CHANNEL WAS SWITCHED AND RECONNECTED THE SAME NEEDLE TO CHANNEL 1. IMPOSSIBLE TO REDO THE TEST. THE SYSTEM WAS TURNED OFF COMPLETELY. TURNED IT ON, TRIED TO DO THE TEST WITH THE PROBE IN THE PATIENT : ERROR MESSAGE APPEARED : CHANGE CHANNEL, OR CHANGE PROBE AND SEND IT TO QUALITY DEPT. THE SYSTEM DIDN'T RECOGNIZE THAT THERE WAS A PROCEDURE IN PROGRESS: GOT A "PROCEDURE NOT OPEN" MESSAGE. THE RADIOLOGISTS WANTED TO USE 3 PROBES. THEY DIDN¿T HAVE ANY EXTRA PROBES AVAILABLE. THEY DECIDED TO POSTPONE THE CASE IN MAY. POSSIBLE INCIDENCE OF CANCER CELL SEEDING BY MOVING THE PROBE AND NOT BEING ABLE TO ABLATE AND DO THE TRACK ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200687 ↗
• InjurySep 13, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ABLATION BUT TIP BROKE OFF IN PATIENT. NO PATIENT HARM.

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

  MAUDE report 17738935 ↗
• InjuryFeb 15, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE A PART OF THE NEEDLE BROKE OFF WHILE GOING WITH IT IN BETWEEN THE RIBS. THE PART FELL IN THE PATIENT AND COULDN'T BE RETRIEVED. NO INDICATION OF PRODUCT FAILURE ACCORDING TO SURGEON BUT RATHER BECAUSE OF DIFFICULT POSITION THAT HAD TO BE REACHED. SURGEON NOW WANTS TO HAVE A MRI OF THE PATIENT TO CHECK ON WHERE THE PIECE IS LOCATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16381405 ↗
• InjuryOct 26, 2022Break; Excessive Heating; Break; Excessive Heating

  IT WAS REPORTED VIA CLINICAL TRIAL (B)(4) THE PROBE WAS USED FOR THE LIVER ABLATION CYCLE. THE PLACEMENT WAS NORMAL AND NO ADJACENT STRUCTURES ASIDE FROM NORMAL LIVER PARENCHYMA. THE CYCLE SHUT OFF PREMATURELY AND AN ERROR MESSAGE APPEARED SAYING THAT PROBE WAS OVERHEATING DUE TO NEARBY FOREIGN BODY. THE IMAGING WAS THEN REVIEWED BY THE CLINICIAN AND NO ABNORMAL FINDINGS WERE REPORTED OR IMMEDIATE THREAT TO THE PATIENT DISCOVERED. HOWEVER, WHEN THE PROBE WAS THEN REMOVED IT WAS FOUND THAT THE TIP (APPROXIMATELY 2CM IN LENGTH) APPEARED TO HAVE BROKEN OFF AND REMAINED INSIDE THE PATIENT EMBEDDED IN THE LIVER SOFT TISSUE (APPROXIMATELY 10CM DEEP). THE PATIENT WAS THEN CLINICALLY EVALUATED FOR SAFETY, BUT THE PROBE PIECE WAS UNABLE TO BE REMOVED IN THE INTERVENTION RADIOLOGY SETTING. THE PATIENT WILL BE REVIEWED AND MANAGED BY THE PATIENT¿S PRIMARY CARE TEAM IN THE NEAR FUTURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15672846 ↗
• MalfunctionOct 13, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHEN THE FACILITY WAS PULLING DEVICES FOR AN ABLATION CASE IT WAS NOTICED THAT THE PRODUCT BOX WAS FOR PR20XT BUT THE PRODUCT INSIDE WAS PR15XT AND THE LABEL ON THE BOX SAYS PR15XT. THERE WERE NO CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595930 ↗
• MalfunctionSep 22, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHEN THE FACILITY WAS PULLING DEVICES FOR AN ABLATION CASE IT WAS NOTICED THAT THE PRODUCT BOX WAS FOR PR20XT BUT THE PRODUCT INSIDE WAS PR15XT AND THE LABEL ON THE BOX SAYS PR15XT. THERE WERE NO CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462636 ↗
• MalfunctionJul 21, 2022Break; Break

  IT WAS REPORTED THAT DURING A MICROWAVE ABLATION OF LIVER TUMOR SEGMENT 8 THE PR20XT WAS USED AS DEFINED. THE PROBE WAS INSERTED WITH NORMAL PRESSURE. WHEN IT WAS INSERTED FOR APPROXIMATELY 1 CM INTO THE SKIN/TISSUE, THE PROBE BROKE (PARTIALLY) A FEW MILLIMETERS ABOVE THE GREEN ZONE. NO RIB OR OTHER HARD STRUCTURE WAS TOUCHED DURING THE INSERTION. THIS PROBE COULD DEFINITELY NOT BE USED ANYMORE DUE TO THE DAMAGE (UNSAFE TO INSERT AGAIN) AND A NEW PROBE HAD TO BE UNPACKED. A NEW NEEDLE WAS USED. THE SURGERY WAS PROLONGED 2 MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074311 ↗
• MalfunctionJun 9, 2022Break; Break

  IT WAS REPORTED THAT DURING THE LIVER ABLATION PROCEDURE, THE PROBE WAS WORKING PROPERLY IN THE LIVER AND THEY WERE DOING A TEN MINUTE ABLATION AND HALF WAY THROUGH, THE ABLATION STOPPED AND WHEN THEY REMOVED THE PROBE, THE TIP OF THE PROBE WAS BROKEN. SO THEY HAD TO REMOVE THE PROBE AND PLACE A NEW PROBE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643151 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN ABLATION THERE WAS A BROKEN NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14621313 ↗
• MalfunctionJun 7, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN ABLATION THERE WAS A BROKEN NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14621229 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VIA AN ABLATION CLINICAL TRIAL (B)(6) THE PATIENT EXPERIENCED PNEUMOTHORAX AND REQUIRED A CHEST DRAIN INSERTION AND EXPERIENCED PAIN. THE PNEUMOTHORAX AND CHEST DRAIN INSERTION HAS A CAUSAL RELATIONSHIP WITH THE DEVICE AND PROCEDURE. DIAGNOSTIC INTERVENTION AND IMAGING WERE REQUIRED. THE ISSUE HAS RESOLVED. THE PAIN HAS A PROBABLE RELATIONSHIP TO THE STUDY DEVICE AND STUDY PROCEDURE. DRUG THERAPY WAS REQUIRED. THIS ISSUE IS RESOLVING.

  Patient problems: Insufficient Information; Pain; Pneumothorax

  MAUDE report 14488916 ↗
• InjuryFeb 24, 2022Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PARTIAL LEFT HEPATECTOMY PROCEDURE WITH MICROWAVE LIVER PRE-TRANSECTION COAGULATION THAT THERE WAS SOME TISSUE BUILDUP IN THE JAWS OF THE DEVICE WHICH RESULTED IN AN ERROR OF REMOVE INSTRUMENT, CLEAN JAWS, AND THEN REPLACE INSTRUMENT. ANOTHER HARMONIC DEVICE WAS USED TO COMPLETE THIS PORTION OF THE PROCEDURE. WHILE DOING THE PRE-TRANSECTION COAGULATION THAT AROUND THE FOURTH MINUTE OF CUMULATIVE CYCLE AT 95 WATTS WHEN THE PROBE WAS RETRIEVED THE TIP WAS MISSING AND STILL IN THE LIVER. MORE LIVER THAN NECESSARY WAS REMOVED TO RETRIEVE THE BROKEN PROBE WHICH ADDED ABOUT AN HOUR TO THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13590825 ↗
• InjuryDec 20, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE DURING A CLINICAL TRIAL THE PATIENT EXPERIENCED ABDOMINAL PAIN. IT REQUIRED ADDITIONAL HOSPITALIZATION, DRUG THERAPY, DIAGNOSTIC IMAGING, AND OBSERVATION. THERE IS A POSSIBLE RELATIONSHIP TO THE STUDY DEVICE. THE PATIENT HAS RECOVERED.

  Patient problems: Abdominal Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13042452 ↗
• MalfunctionNov 1, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL TRIAL ABLATION THE PATIENT EXPERIENCED POST-OP PAIN. THE PAIN WAS MILD AND WAS NOT A SERIOUS EVENT. DRUG THERAPY WAS GIVEN. THE RELATIONSHIP WITH THE STUDY DEVICE WAS UNLIKELY. THE RELATIONSHIP WITH THE STUDY PROCEDURE WAS CAUSAL. THE OUTCOME WAS RECOVERED/RESOLVED.

  Patient problems: Pain

  MAUDE report 12729511 ↗
• MalfunctionOct 8, 2021Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ABLATION WITH 2PR XT PROBES (20CM) FOR 10 MINUTES 65WATT EACH. AFTER THE PROCEDURE THE PROBES WERE REPOSITIONED. STARTED A SECOND CYCLE FOR 5 MINUTES AND AN ERROR MESSAGE APPEARED AFTER TWO +/- 2 MINUTES ON ONE OF THE PROBES (NO CONTACT ERROR).THE SECOND PROBE COULD STILL ABLATE BUT GAVE AN ERROR MESSAGE ONE MINUTE LATER. THEY TRIED TO RECONNECT THE PROBES AFTER ERROR MESSAGE. THEY COULD NOT ABLATE ANYMORE WITH THE PROBES. A REFLECTIVE POWER MESSAGE WAS THERE. AFTER REMOVING THE PROBE WE¿VE NOTICED ONE WAS IN A 90 DEGREE ANGLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12600977 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMMEDIATELY FOLLOWING A LAPAROSCOPIC PTC PROCEDURE THE PHYSICIAN NOTICED THIRD DEGREE BURNS AT THE INCISION SITE. THE PATIENT WAS TREATED FOR A THERMAL INJURY. CALL HOME DATA REVEALED MULTIPLE REFLECTIVE POWER ERRORS DURING THE CASE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 12585088 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMMEDIATELY FOLLOWING A LAPAROSCOPIC PTC PROCEDURE THE PHYSICIAN NOTICED THIRD DEGREE BURNS AT THE INCISION SITE. THE PATIENT WAS TREATED FOR A THERMAL INJURY. CALL HOME DATA REVEALED MULTIPLE REFLECTIVE POWER ERRORS DURING THE CASE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 12585058 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A CLINICAL TRIAL (B)(6) ABLATION THE PATIENT EXPERIENCED PAIN. THE PATIENT REQUIRED PROLONGED IN-PATIENT HOSPITALIZATION WITH DRUG THERAPY. THE DEVICE RELATIONSHIP WITH THE PAIN IS UNLIKELY AND THE PROCEDURE RELATIONSHIP WITH THE PAIN IS PROBABLE. THE PATIENT'S OUTCOME IS RECOVERED/RESOLVED.

  Patient problems: Pain

  MAUDE report 12459555 ↗
• InjuryAug 12, 2021Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ABLATION WITH 2PR XT PROBES (20CM) FOR 10 MINUTES 65WATT EACH. AFTER THE PROCEDURE THE PROBES WHERE REPOSITIONED. STARTED A SECOND CYCLE FOR 5 MINUTES AND AN ERROR MESSAGE APPEARED AFTER TWO +/- 2 MINUTES ON ONE OF THE PROBES (NO CONTACT ERROR).THE SECOND PROBE COULD STILL ABLATE BUT GAVE AN ERROR MESSAGE ONE MINUTE LATER. AFTER REMOVAL OF THE PROBES ONE PROBES WAS FOUND TO BE BROKEN AND THE TIP WAS LEFT BEHIND IN THE PATIENT (SEEN AFTERWARDS ON THE CT). DISTANCE BETWEEN PROBE EMITTING POINTS WAS BETWEEN 1,7 AND 1,5 CM. A DATA CALL HOME DATE TRANSFER HAS BEEN MADE AND IS RECEIVED. (HOSPITAL HAS A SIGNED CALL HOME AGREEMENT). TRIED TO RECONNECT THE PROBES AFTER ERROR MESSAGE. COULD NOT ABLATE ANYMORE WITH ONE PROBE AND LATER THE SECOND PROBE STOPPED AS WELL. THE REFLECTIVE POWER MESSAGE WAS THERE. AFTER REMOVING THE PROBES WE¿VE NOTICED ONE WAS IN A 90 DEGREE ANGLE AND THE OTHER ONE WAS FULLY BROKEN. ON THE CT YOU CAN SEE A SMALL PIECE (7MM LONG?) OF PROBE LEFT BEHIND IN THE LIVER. ACCORDING TO THE USER IT LOOKED DEEPER THAN WHERE THE PROBE INITIALLY WAS LOCATED. SPACING BETWEEN THE PROBES WAS 1,5 ¿ 1,6 CM.

  Patient problems: Foreign Body In Patient

  MAUDE report 12316330 ↗