NEUWAVE PR15Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00853719006395), received between Jun 21, 2017 and Jun 9, 2026 — classified as 3 deaths, 46 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (24 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. 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 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Break

  IT WAS REPORTED, THAT WHILE IN AN ABLATION PROCEDURE, WHEN PULLING OUT THE PROBE IT HAD BROKEN DURING THE PROCEDURE INSIDE THE PATIENT. THE PROBE WAS REMOVED IN FULL, NO PIECES LEFT BEHIND. THE ABLATION WAS COMPLETED PRIOR TO BREAK, BUT DURING CAUTERY IT MALFUNCTIONED AND THAT IS WHERE THE BREAK IS SUSPECTED TO HAVE HAPPENED. POST ABLATION CT SCAN SHOWED GAS IN THE PATIENT'S ABDOMEN. PROBE WAS NOT KEPT FOR RETURN DUE TO PATIENT BE HEP B POSITIVE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444563 ↗
• InjuryNov 19, 2025Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A LUNG ABLATION PROCEDURE THAT THE DEVICE DISPLAYED, "SYSTEM ERROR ON CHANNEL," AFTER THE PROBE HAD BEEN PLACED IN THE PATIENT. THE PROBE WAS REINSTALLED IN CHANNEL 2 AND 3 AND THE ISSUE PERSISTED. THE PROBE WAS REPLACED AND THE ISSUE WAS RESOLVED.

  Patient problems: Pneumothorax

  MAUDE report 23596805 ↗
• InjuryNov 4, 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 A LUNG ABLATION PROCEDURE THE DEVICE STOPPED WORKING AFTER APPROXIMATELY 90 SECONDS OF ABLATION AND CEASED FUNCTIONING ON ITS OWN. A SMALL PNEUMOTHORAX OCCURRED DURING REMOVAL OF THE PROBE.

  Patient problems: Pneumothorax

  MAUDE report 23464895 ↗
• InjuryNov 7, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ABLATION WHEN THEY WERE USING THE PROBES SIMULTANEOUSLY WHILE USING THE SECOND PROBE IN CHANNEL A THE ABLATION SYSTEM HAD SHUT DOWN WHEN THE PHYSICIAN DIDN'T DO ANYTHING TO MAKE IT DO SO. WHEN THEY WENT TO TAKE THE PROBE OUT OF THE PATIENT, THE TIP OF IT HAD BROKEN OFF. THE TIP IS STILL IN THE PATIENT.

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

  MAUDE report 20630729 ↗
• MalfunctionNov 7, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ABLATION THE PROBE TIP BROKE OFF WHEN THEY REMOVED IT FROM THE BOX UPON USAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630511 ↗
• InjurySep 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A MICROWAVE ABLATION OF THE BONE, THEY FINISHED THE ABLATION, AS THEY PULLED THE PROBE OUT, THE PROBE TIP BROKE OFF AND GOT STUCK IN THE PATIENTS LEFT ARM, THE CORTEX. CALLED ORTHO IN TO OPEN UP AND GET THE NEEDLE OUT OF THE BONE. CASE WAS DELAYED AN EXTRA HOUR. CASE WAS ABLE TO BE COMPLETED. NO ADDITIONAL PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 20321182 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE LIVER ABLATION AND THE PATIENT EXPERIENCED ABDOMINAL WALL PAIN/BURN. THEY ARE CURRENTLY SURVEYING THE PATIENT FOR ANY FURTHER COMPLICATIONS. SURGEON BELIEVED IT COULD BE TIED TO THE ANGLE THAT THE PROBES WERE PLACED AT WITHIN THE PATIENT THAT LED TO THE POST-OP REACTION.

  Patient problems: Burn(s); Pain

  MAUDE report 20318605 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE LIVER ABLATION AND THE PATIENT EXPERIENCED ABDOMINAL WALL PAIN/BURN. THEY ARE CURRENTLY SURVEYING THE PATIENT FOR ANY FURTHER COMPLICATIONS. SURGEON BELIEVED IT COULD BE TIED TO THE ANGLE THAT THE PROBES WERE PLACED AT WITHIN THE PATIENT THAT LED TO THE POST-OP REACTION.

  Patient problems: Burn(s); Pain

  MAUDE report 20318045 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A PTC LIVER PROCEDURE THAT THE TWO PROBES WERE TESTED AND PASSED. THE PROBES WERE INSERTED INTO THE PATIENT. THE PROBE IN CHANNEL TWO WOULD NOT START AND KEPT SHUTTING OFF. WHEN THE PROBE WAS REMOVED IT WAS FOUND THAT THE TIP HAD BROKEN OFF. THE TIP WAS FOUND AND RECOVERED FROM THE LIVER. 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 19959824 ↗
• MalfunctionMar 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN ABLATION THE PROBE WAS PERFORMING BUT AFTER AWHILE IT TURNED OFF AND STOPPED WORKING. THEY GOT ANOTHER ONE TO COMPLETE THE CASE WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18964782 ↗
• MalfunctionJul 24, 2023Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Gas/Air Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL (B)(4) DURING A MICROWAVE ABLATION OF SOFT TISSUE LIVER LESIONS THE PATIENT EXPERIENCED A SUBCUTANEOUS EMPHYSEMA. THE RELATIONSHIP TO STUDY DEVICE IS PROBABLE. THE RELATIONSHIP TO THE STUDY PROCEDURE IS POSSIBLE. NO TREATMENT WAS NECESSARY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17379937 ↗
• MalfunctionJul 14, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED WHO WAS IN THE CASE THAT DURING A LIVER ABLATION PROCEDURE THAT BUBBLES APPEARED WHILE TESTING THE PROBE IN SALINE. ANOTHER PROBE 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 17327947 ↗
• MalfunctionJul 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE LIVER ABLATION PROCEDURE THAT THE DOCTOR REPORTED THAT THE ABLATIONS ZONE WAS SMALLER THAN USUAL. THEY HAD TO DO A COUPLE OF ADDITIONAL BURNS TO GET PROPER ABLATION ZONE. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317250 ↗
• InjuryMar 29, 2023Break; Temperature Problem; Break; Temperature Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WERE NUMEROUS TISSUE LOCK AND ACTIVE THERMOCOUPLE FAILING ERROR MESSAGES THAT APPEARED. THE PROBE WAS REMOVED TO ASSESS PROBLEM AND THE PROBE WAS COMPLETELY DAMAGED. BITS OF THE WIRE HAD ACTUALLY DETACHED FROM THE PROBE AND MOST WAS RETRIEVED BUT SOME ELEMENTS STILL IN PATIENT PLURAL CAVITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16638220 ↗
• MalfunctionJan 4, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE NEEDLE BROKE AT THE HUB INSIDE OF THE PATIENT. THE NEEDLE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094452 ↗
• MalfunctionSep 14, 2022Break; Break

  IT WAS REPORTED THAT DURING THE ABLATION SURGERY THAT A PROBE BROKE DURING A CASE AS PART OF THE IIS ALLUME STUDY (NW-2017-01). A PR15 NEEDLE WAS USED TO TARGET A RIGHT UPPER LOBE LESION. THE NEEDLE TESTED NORMALLY BEFORE USE AND ADVANCED EASILY INTO THE TARGET LESION. ONCE IT WAS IN POSITION, HOWEVER, IT WAS FELT THAT THE CONNECTION BETWEEN THE HUB AND THE NEEDLE HAD BECOME LOOSE, AND THE HUB HAD BECOME SEPARATED FROM THE NEEDLE . THERE WAS NO UNUSUAL TENSION OR TORQUING OF THE HUB OR ON THE CABLES. ONLY ONE PERSON WAS MANIPULATING THE NEEDLE. GIVEN THIS, THE NEEDLE WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY AND A NEW PR15 PROBE WAS USED FOR THE PROCEDURE. NO HARM CAME TO THE PATIENT, AND THE PROCEDURE OTHERWISE WENT SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417588 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE NEEDLE PORTION BROKE OFF DURING PROBE PLACEMENT WHILE ¿PORQUING¿. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415325 ↗
• InjurySep 12, 2022Manufacturing, Packaging or Shipping Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Manufacturing, Packaging or Shipping Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE WHEN THE DOCTOR OPENED THE PROBE, IT WAS PACKAGED WITH AN UPWARDS ANGEL. THERE WAS A PATIENT CONSEQUENCES OF PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 15402136 ↗
• InjuryApr 21, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TITLE: NEEDLE TRACT RECURRENCE OF RENAL CELL CARCINOMA AFTER MICROWAVE ABLATION. AUTHORS: TELLA DAVID, LAMBERT DREW, SCHENKMAN, NOAH S. CITATION: J CLIN MED IMG CASE REP. 2022; 2(1): 1091. THIS STUDY REPORTS A PATIENT THAT UNDERWENT TRANSHEPATIC MICROWAVE ABLATION OF A RIGHT RENAL CANCER AND DEVELOPED A TUMOR ALONG THE ABLATION TRACT. THE PATIENT IS A (B)(6) MALE WITH COMPLEX MEDICAL HISTORY INCLUDING HEART DISEASE, HYPERTENSION, CHRONIC KIDNEY DISEASE, AND SLEEP APNEA WHO PRESENTED WITH A 4 CM RIGHT RENAL MASS DISCOVERED INCIDENTALLY FOLLOWING CT IMAGING FOR UNRELATED ABDOMINAL PAIN. A BIOPSY OF THE MASS REVEALED A FUHRMAN GRADE 2 CLEAR CELL RENAL CELL CARCINOMA (RCC). TREATMENT OPTIONS WERE DISCUSSED, AND THE PATIENT ELECTED MICROWAVE ABLATION THERAPY. THREE PR-15 NEUWAVE MEDICAL MICROWAVE PROBE (ETHICON) WERE INSERTED TRANSHEPATICALLY INTO THE UPPER POLE RENAL TUMOR. CORRECT POSITIONING OF THE PROBES WITHIN THE MASS WAS CONFIRMED WITH ULTRASOUND AND ABDOMINAL CT SCAN. IMMEDIATE POST PROCEDURE FILMS SHOWED COMPLETE ABLATION OF THE TUMOR AND THE ADJACENT CYST. SIGNIFICANTLY, THE ENTIRE TRANS-HEPATIC TRACT WAS ABLATED DURING REMOVAL OF THE MICROWAVE PROBES, AS PART OF THE PROTOCOL.

  Patient problems: Cancer; Hematuria; Pain

  MAUDE report 14166467 ↗
• InjuryApr 11, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING CLINICAL TRIAL (B)(6), DURING A MICROWAVE ABLATION OF SOFT TISSUE LIVER LESIONS, THE PATIENT EXPERIENCED INFARCTION. THERE IS NO RELATIONSHIP TO THE STUDY PROCEDURE BUT THERE IS A PROBABLE RELATIONSHIP TO THE STUDY DEVICE. NO TREATMENT WAS PROVIDED. THE PATIENT HAS RECOVERED/INCIDENT WAS RESOLVED.

  Patient problems: Ischemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073687 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CT TECH ALERTED ME THAT THEY HAD A CASE IN LATE 2021, EXACT DATE UNKNOWN RIGHT NOW BUT SHE IS INVESTIGATING, WHERE THE CERTUS 140 CAUSED THEIR SIEMENS SCANNER TO SHUTDOWN COMPLETELY. CERTUS 140 WAS SET UP WITHIN A FEW FEET OF THE SCANNER. THE PDM WAS CLAMPED TO BED PLATE ON THE CT SCANNER. THIS INCIDENT RESULTED IN PATIENT INJURY. AS THIS HAS JUST BEEN REPORTED TO ME, THE PROBE LOT IS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS PATIENT CONSEQUENCES. PATIENT HAD A 3RD DEGREE BURN AND WAS TREATED FOR IT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 14054646 ↗
• MalfunctionMar 30, 2022Break; Break

  IT WAS REPORTED THAT DURING A LIVER RESECTION PROCEDURE THE TIP BROKE OFF OF THE PROBE. UNKNOWN IF THE FRAGMENT WAS RETRIEVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. SURFACE OF SPECIMEN WAS EXAMINED BUT NOT FRAGMENT WAS FOUND. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13953348 ↗
• MalfunctionMar 1, 2022Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT AT THE END OF THE ABLATION, THE TEMPERATURE DROPPED TO 0 DEGREES, AND IT WAS NOT CLEAR WHETHER THE ABLATION WAS COMPLETELY ACHIEVED WITH THE PROBE. A NEW PROBE WAS OPENED TO COMPLETE THE ABLATION WITH THE DESIRED RESULT. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635781 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED THAT DURING A MICROWAVE ABLATION FOR A RENAL TUMOR THAT DURING PLACEMENT OF THE PROBE, THE NEEDLE BENT VERY BADLY AND CRACKED LOUDLY, BUT WITHOUT BREAKING OFF. NEEDLE WAS COMPLETELY REMOVED AND IT WAS SEEN THAT THE NEEDLE WAS BROKEN. NO PATIENT HARM. INTERVENTION WAS CONTINUED WITH A NEW NEEDLE AND FINISHED WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13209417 ↗
• InjuryNov 10, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL TRIAL (B)(6) THE PATIENT EXPERIENCED A PERIHEPATIC HEMATOMA THAT REQUIRED BEING TRACT RE-CAUTERIZED. THE RELATIONSHIP TO THE STUDY DEVICE AND STUDY PROCEDURE IS PROBABLE RELATION TO THE AE. THE PATIENT HAS RECOVERED.

  Patient problems: Hematoma

  MAUDE report 12786581 ↗