NEUWAVE PR15XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00853719006401), received between May 2, 2017 and Sep 21, 2026 — classified as 63 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (35 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 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848060 ↗
• InjuryAug 20, 2025Break; Break

  IT WAS REPORTED DURING AN ABLATION PROCEDURE THE TIP OF THE PROBE BROKE OFF. HE WAS NOT OPERATING UNDER A BONE OR ANYTHING SIMILAR. THERE WERE NO PATIENT ADVERSE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22852317 ↗
• InjuryJun 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A CT GUIDED LIVER ABLATION THAT THE PROBE WAS BEING GUIDED BETWEEN THE RIBS AND THE PROBE TIP BROKE OFF AND IS LODGED IN THE CARTILAGE BETWEEN THE RIBS. A NEW PROBE WAS USED TO CONTINUE WITH THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22197434 ↗
• InjuryMar 21, 2025Adverse 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 AN ABLATION PROCEDURE, WHEN USING AN ABLATION PROBE, IT DOES NOT STORE THE "BUBBLES" TEST IN ITS MEMORY AND REQUESTED IT WHILE THE PROCEDURE WAS IN PROGRESS ON THE PATIENT, FORCING ITS REMOVAL AND RE-TESTING. THIS NECESSITATED THREE PASSAGES INSTEAD OF THE USUAL ONE. THE BUBBLE TEST WAS PERFORMED TWICE MORE, THEN THE PROBE WAS CHANGED FOR ANOTHER MODEL OF THE SAME REFERENCE AND LOT, THIS TIME SUCCESSFULLY. A WEEK LATER, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND CONSULTED US. A CT SCAN WAS PERFORMED AND AIR WAS VISUALIZED IN THE LIVER LESIONS. THE CT SCAN IS USUALLY DONE 1 MONTH AFTER THE OPERATION, SO NO COMPARISON IS POSSIBLE AT THIS STAGE, BUT THERE IS A POTENTIAL EFFECT DUE TO THE PROBE PROBLEM. AT PRESENT, THE PATIENT IS DOING WELL, BUT IS EXPERIENCING ABDOMINAL PAIN, WHICH IS NOT FREQUENT FOLLOWING THIS TYPE OF OPERATION.

  Patient problems: Abdominal Pain; Abscess; Unspecified Infection

  MAUDE report 21663447 ↗
• InjuryFeb 21, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING AN ABLATION, THEY HAD A THREE PROBE ABLATION GOING. CHANNEL THREE PROBE, UNDER ULTRASOUND THE GAS WAS EMITTING BACK WAY UP THE SHAFT NOT JUST ON THE EMITTING ZONE. THE GAS WAS SEEN OUTSIDE THE EMITTING ZONE, WITHIN THE FIRST THIRTY SECONDS AND THEN CONTINUOUS. THEY STOPPED ABLATION WITH CHANNEL THREE. THEY CONTINUED ABLATION WITH CHANNEL ONE AND TWO. THEY SHUT OFF CHANNEL THREE. AND PRECEDED WITH CHANNEL ONE AND TWO FOR AN ADDITIONAL THIRTY SECONDS. AND THEN PAUSED ALL CHANNELS AND DID A CT SCAN. CASE WAS COMPLETED WITH TANK A. WHILE RUNNING ON TANK A THERE WAS AN ABNORMAL CLICKING SOUND. NO PATIENT HARM WAS REPORTED.

  Patient problems: Abscess; Hematoma; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 21433356 ↗
• InjuryDec 20, 2024Break; Break

  IT WAS REPORTED THAT WHEN THEY STARTED ABLATING, ONE OF THE TWO PROBES BEGAN TO FAIL AFTER THE FIRST MINUTE. SURGEON CONTINUED THE CASE WITH JUST ONE PROBE. AFTER COMPLETING THE CASE, THEY WENT TO REMOVE THE FAILED PROBE BUT THE TIP OF IT STARTED TO DANGLE. A SMALL FRAGMENT WAS SEEN IN THE KIDNEY ON X-RAY. NO PLANS MADE TO REMOVE IT DUE TO IT NOT BEING SET TO CAUSE ANY FURTHER HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20988155 ↗
• InjuryDec 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE THAT THE PROBE BROKE IN THE PATIENT DUE TO THE CORD BEING PULLED OUT WHILE THE PATIENT WAS BEING SCANNED. 1 CM OF THE PROBE WAS LEFT IN THE PROBE. IT¿S UNKNOWN IF A FUTURE PROCEDURE WILL BE MADE TO REMOVE THE REMAINDER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20907071 ↗
• MalfunctionDec 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LIVER MICROWAVE ABLATION THAT THE ABLATION TEMPERATURE IS CONSTANTLY AROUND 92 DEGREE C (S7, 2.5 CM LESION) FOR THE FIRST CYCLE 7 MINUTES. THE ABLATION ZONE IS NOT LARGE ENOUGH AS EXPECTED WHICH BELOW 100 DEGREE C, THUS HE HAS TO ADD ANOTHER CYCLE 2:50MINS. NO PARTS OF THE INSTRUMENT LEFT INSIDE PATIENT'S CAVITY. THE PROCEDURE WAS DELAYED 2:50MINS BUT COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905892 ↗
• InjuryOct 11, 2024Break; Excessive Heating; Break; Excessive Heating

  IT WAS REPORTED THAT DURING A LIVER ABLATION PROCEDURE THAT WHILE USING TWO PROBES THE TEMPERATURE WAS GETTING PRETTY HIGH AND WOULD SHUT OFF AND ON. WHEN PROBES WERE REMOVED IT WAS FOUND THAT THE TIPS HAD "BURNT" OFF AND WERE LEFT IN THE PATIENT. A THIRD PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES OTHER THAN THE TIPS OF THE FIRST TWO PROBES BEING LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20426467 ↗
• InjuryOct 11, 2024Break; Excessive Heating; Break; Excessive Heating

  IT WAS REPORTED THAT DURING A LIVER ABLATION PROCEDURE THAT WHILE USING TWO PROBES THE TEMPERATURE WAS GETTING PRETTY HIGH AND WOULD SHUT OFF AND ON. WHEN PROBES WERE REMOVED IT WAS FOUND THAT THE TIPS HAD "BURNT" OFF AND WERE LEFT IN THE PATIENT. A THIRD PROBE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES OTHER THAN THE TIPS OF THE FIRST TWO PROBES BEING LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20426455 ↗
• MalfunctionAug 22, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LIVER ABLATION PROCEDURE THAT PRIOR TO INTRODUCTION INTO THE PATIENT THE TIP OF THE PROBE BROKE BUT DID NOT DID NOT DETACH. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20029563 ↗
• MalfunctionAug 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN ABLATION THE DEVICE'S ABLATION ZONES ARE A LOT SMALLER THAN WHAT THEY ARE SUPPOSED TO BE ACCORDING TO THE PHYSICIAN THAT HAS HAD AN ISSUE WITH IT FOR A GOOD BIT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19914376 ↗
• MalfunctionJun 11, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED ONE MANUFACTURERS BOX THAT HAD NO PRODUCT CODE, LOT NUMBER, OR EXPIRATION DATE REFERENCED AND THERE WAS A LABEL THAT SAYS, ¿NOT FOR HUMAN USE¿. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509871 ↗
• MalfunctionApr 16, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE THE PROBE TIP WAS BROKEN WHILE TRYING TO REACH DEEP LESION. NO PROBE COMPONENTS WERE LEFT INSIDE PATIENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115449 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA AN ABLATION CLINICAL TRIAL (B)(6) THE PATIENT EXPERIENCES SMALL RIGHT PNEUMOTHORAX AND SUBCAPSULAR HEMATOMA. THE RELATIONSHIP TO THE STUDY DEVICE FOR BOTH EVENTS IS POSSIBLE AND THE RELATIONSHIP TO THE STUDY PROCEDURE FOR BOTH EVENTS IS CAUSAL. BOTH EVENTS REQUIRED IN-PATIENT OR PROLONGATION OF EXISTING HOSPITALIZATION. THE SMALL RIGHT PNEUMOTHORAX WAS TREATED WITH NEEDLE EXUFFLATION. THERE WAS NO TREATMENT FOR THE SUBCAPSULAR HEMATOMA.

  Patient problems: Hematoma; Pneumothorax

  MAUDE report 19070079 ↗
• MalfunctionMar 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A LIVER ABLATION PROCEDURE THAT THE TIP OF THE PROBE BROKE OFF IN THE LIVER. FRAGMENT WAS FOUND AND REMOVED. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847027 ↗
• MalfunctionFeb 23, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED DAMAGED PRODUCT. THE PACKAGING HAD HOLES AND THE STERILE PACKAGING HAS A HOLE IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769304 ↗
• MalfunctionDec 15, 2023Adverse Event Without Identified Device or Use Problem; Excessive Heating; Adverse Event Without Identified Device or Use Problem; Excessive Heating

  IT WAS REPORTED THAT DURING THE ABLATION, 2 PROBES WERE 1 CM APART, BUT AFTER PROCEDURE THEY NOTICED HIGHER TEMPERATURE ON ONE OF THEM AROUND 165 DEGREES CELSIUS. WHEN THEY PULLED OUT PROBE, THEY NOTICED SKIN BURN/FROST BITE ON THE PATIENT. NO ERROR CODES FOR THE DEVICES WERE SHOWN. ONCE PULLED OUT, AN ENGINEER TESTED THE PROBE WITH HIGH TEMPERATURE IN WATER AND IT SEEMED TO WORK FINE.

  Patient problems: Burn(s)

  MAUDE report 18340166 ↗
• InjuryNov 20, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, PR15XT PROBE TIP BROKE OFF IN PATIENT AND HAD TO BE RETRIEVED VIA INCISION OF SKIN AND STITCHED BACK UP. THE PHYSICIAN BARELY ATTEMPTED TO INSERT THE PROBE AND IT BROKE OFF. TIP PARTS HAD TO BE EXTRACTED VIA EXTRA SCANS AND CUTTING INTO SKIN SITE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18169385 ↗
• InjuryNov 20, 2023Break; Break

  IT WAS REPORTED THAT DURING AN INTERVENTIONAL IMAGING, IT WAS OBSERVED THAT AFTER 7 MINUTES OF TREATMENT TO ABLATE A LIVER TUMOR, THE DEVICE WAS FOUND TO BE IN ERROR ON ONE OF THE TWO NEEDLES, WITH AN ERROR MESSAGE BEING DISPLAYED. AFTER SEVERAL ATTEMPTS TO RESTART THE ABLATION, AND AN ATTEMPT TO CHANGE THE CHANNEL, THE NEEDLE WAS WITHDRAWN. IT WAS FOUND THAT THE TIP OF THE NEEDLE HAD BEEN DAMAGED AND THAT A PIECE HAD REMAINED IN THE PATIENT'S LIVER. IMAGING WAS PERFORMED AND CONFIRMED THE PRESENCE OF THE FRAGMENT. NO REMOVAL OF THE FRAGMENT IS PLANNED. THIS INCIDENT ALSO EXPOSED THE PATIENT TO THE RISK OF PARTIAL REMOVAL OF THE LIVER TUMOUR.

  Patient problems: Foreign Body In Patient

  MAUDE report 18169311 ↗
• MalfunctionNov 3, 2023Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING THE LEFT ADRENAL ABLATIONS PROCEDURE THAT WHILE USING UP TO THREE PROBES. ONE PROBE STOPPED WORKING AND WOULD NOT ALLOW THEM TO RETEST. THE PROBLEM WITH THE PROBE DID NOT CAUSE ANY DAMAGE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064420 ↗
• InjuryOct 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ABLATION THE PROBE STOPPED WORKING. IT STOPPED AFTER 7 MINUTES OF TREATMENT. THE RADIOLOGIST RESTARTED THE ABLATION MODE BUT THE PROBE WAS NOT WORKING. HE PLUGGED THE PROBE BACK INTO ANOTHER CHANNEL BUT IT STILL DIDN'T WORK. THEY USED A SECOND PROBE AND THE TREATMENT WENT WELL AFTERWARDS. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17878358 ↗
• MalfunctionSep 25, 2023Break; Break

  IT WAS REPORTED THAT DURING ABLATION THE PROBE TIP MELTED OFF IN THE PATIENT WHILE ON THE TABLE. IT WAS RETRIEVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807028 ↗
• MalfunctionSep 22, 2023Break; Material Integrity Problem; Excessive Heating; Break; Material Integrity Problem; Excessive Heating

  IT WAS REPORTED THAT DURING AN ABLATION THEY HAD A PATIENT INCIDENT WITH A PROBE TIP BREAKING OFF INSIDE THE PATIENT. BURNED FOR 4 TO 4.5 MINUTES. TEMPERATURE JUMPED UP SIGNIFICANTLY AND THEN STOPPED, REFLECTED POWER ERROR. THEY TRIED TO TURN IT ON AGAIN AND IT BURNED FOR A SECOND BEFORE THEY REALIZED THE TIP BURNED OFF. NO PATIENT CONSEQUENCE SINCE THE PROBE TIP WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17803128 ↗
• InjurySep 22, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT TWO MINUTES IN THE SURGERY THEY RECEIVED AN ERROR "REFLECTIVE POWER." THEY ATTEMPTED TO TROUBLE SHOOT THEY DECIDED THEY NEEDED TO CHANGE PROBE AND UPON REMOVING PROBE, THEY NOTICED THE PROBE WAS NOT THERE AND THAT IT HAD BROKEN OFF INSIDE OF PATIENT. THEY FINISHED THE PROCEDURE AND CALLED REP. THE TIP IS CURRENTLY IN THE BACK MUSCLE OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17801043 ↗