NEUWAVE PR20Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00853719006418), received between Jun 23, 2017 and Oct 9, 2025 — classified as 11 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF PROBE BROKE IN CIRRHOTIC LIVER POST ABLATION. PATIENT WAS SENT TO SURGERY TO REMOVE FRAGMENTS. NO DELAY WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23255375 ↗
• InjuryJun 6, 2024Break; Failure to Read Input Signal; Gas/Air Leak; Appropriate Device Problem Term/Code Not Available; Break; Failure to Read Input Signal; Gas/Air Leak; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN ABLATION THEY TESTED THE PROBE AND IT TESTED FINE. THEY POSITIONED IT. RAN FOR 10 MINUTES AT 65 WATTS. DURING THE NEXT ABLATION THERE WAS AN ERROR MESSAGE AND THEY REMOVED IT AND FOUND THE TIP HAD STAYED INSIDE THE PATIENT. PATIENT HAD TO HAVE SURGERY TO HAVE IT REMOVED. THEY REPORTED THAT WHILE EXPECTING THE DEVICE THAT THEY NOTICED AN EXTERNAL LEAK FROM IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19478171 ↗
• InjuryMar 21, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A KIDNEY ABLATION THEY WANTED TO ABLATE THE HYPERVASCULARIZED TUMOR. AFTER THE SECOND ABLATION (BECAUSE OF REPOSITIONING) THE SYSTEM BLOCKED AND SAID THE PROBE CAN NOT BE USED IN A SECOND PATIENT. THE ERROR COULD NOT BE SKIPPED. SO THEY HAD TO REMOVE THE PROBE WITHOUT TRACK ABLATION. BLEEDING HAPPENED AND TUMOR SEEDING IS POSSIBLE. THEY OPENED A NEW PROBE AND FINISHED THE PROCEDURE. POSSIBLE PATIENT HARM BLEEDING AND POSSIBLE TUMOR SEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 18949312 ↗
• MalfunctionSep 13, 2023Break; Break

  IT WAS REPORTED THAT DURING ABLATION THE PROBE WAS OPENED AND THE TIP WAS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17738748 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL TRIAL (B)(6), THE PATIENT EXPERIENCED, NONOCCLUSIVE LEFT PORTAL VEIN THROMBUS, LEFT PORTAL VEIN THROMBUS, INCREASED LFTS, TOTAL BILIRUBIN INCREASED, AND HEMORRHAGE. THE RELATIONSHIP OF THE STUDY DEVICE TO THE NONOCCLUSIVE LEFT PORTAL VEIN THROMBUS AND LEFT PORTAL VEIN THROMBUS IS UNLIKELY. THE RELATIONSHIP OF THE STUDY DEVICE TO INCREASED LFTS AND TOTAL BILIRUBIN INCREASED IS POSSIBLE. THE RELATIONSHIP OF THE STUDY DEVICE TO THE HEMORRHAGE IS CAUSAL. THE RELATIONSHIP OF THE STUDY PROCEDURE TO ALL 5 AES IS CAUSAL. THERE WAS NO TREATMENT FOR THE HEMORRHAGE, NONOCCLUSIVE LEFT PORTAL VEIN THROMBUS AND LEFT PORTAL VEIN THROMBUS. THE ONLY TREATMENT FOR INCREASED LFTS AND TOTAL BILIRUBIN INCREASED WAS OBSERVATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 17558105 ↗
• MalfunctionMar 1, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ABLATION THE NEEDLE BREAKS FROM ITS BASE DURING POSITIONING IN THE OPERATIVE AREA. THE EVENT IS ATTRIBUTED BY THE SURGEON TO SCAR TISSUE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16463700 ↗
• MalfunctionJan 9, 2023Break; Break

  IT WAS REPORTED THAT DURING AN MICROWAVE LIVER ABLATION PROCEDURE THAT THE DOCTOR OPENED THE PROBE AND WENT TO PLACE IT IN THE LIVER. HE STATED THE LIVER WAS VERY DENSE AND COULD BARELY PUSH IN AND WHEN HE DID, THE DEVICE JUST BENT AND BROKE IN HALF. THE PROBES HE SWITCHED TO COMPLETE THE PROCEDURE, HAD A THICKER NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16125055 ↗
• MalfunctionJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY USED AN ABLATION AND STATED THERE WAS SOFT TISSUE DAMAGE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16115017 ↗
• InjuryNov 2, 2022Adverse 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 LIVER ABLATION PROCEDURE THAT IT WAS NOTICED THAT THE PROBES WERE BURNING THE PATIENT¿S SKIN. WHEN ATTEMPTING TO ABLATE IN ANOTHER AREA ONE OF THE TWO PROBES WOULD NOT COME UP TO TEMP. ALSO, THROUGHOUT THE PROCEDURE THE SYSTEM WOULD POP UP AN UNKNOWN PURPLE ICON AT WHICH TIME THEY WOULD HAVE TO CLICK CONTINUE TO ABLATE. SYSTEM WOULD NOT ABLATE FOR THE ENTIRE TEN MINUTES AT A TIME. THIRD DEGREE BURN WAS BEING EXCISED AND DEBRIDED. PATIENT DOING FINE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 15715997 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LIVER ABLATION PROCEDURE THAT IT WAS NOTICED THAT THE PROBES WERE BURNING THE PATIENT¿S SKIN. WHEN ATTEMPTING TO ABLATE IN ANOTHER AREA ONE OF THE TWO PROBES WOULD NOT COME UP TO TEMP. ALSO, THROUGHOUT THE PROCEDURE THE SYSTEM WOULD POP UP AN UNKNOWN PURPLE ICON AT WHICH TIME THEY WOULD HAVE TO CLICK CONTINUE TO ABLATE. SYSTEM WOULD NOT ABLATE FOR THE ENTIRE TEN MINUTES AT A TIME. THIRD DEGREE BURN WAS BEING EXCISED AND DEBRIDED. PATIENT DOING FINE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 15715918 ↗
• MalfunctionMay 18, 2022Break; Break

  IT WAS REPORTED THAT DURING A LIVER ABLATION WHILE APPLYING CONSTANT PRESSURE AGAINST THE RIB THE PROBE BROKE AND FRAGMENTED 3-4 CM DISTAL TO THE GREEN HUB. THE FRAGMENT WAS RETRIEVED AND THE CASE RESCHEDULED FOR ANOTHER DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432274 ↗
• MalfunctionMar 20, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN LAPAROSCOPIC ABLATION THE PROBE BROKE RIGHT BY THE HANDLE. THE CASE WAS COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13829644 ↗
• InjuryMar 2, 2022Break; Break

  IT WAS REPORTED THAT DURING A BONE ABLATION CASE A SMALL PORTION OF THE PR20 ABLATION PROBE APPEARED TO BREAK OFF INTO THE PATIENT¿S BONE WHICH WAS VISUALIZED THROUGH CT. THE PROCEDURE WAS COMPLETED USING THE PROBE PREVIOUSLY MENTIONED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13654490 ↗
• MalfunctionOct 29, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE PR20 BROKE THREE QUARTERS OF THE WAY DOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720371 ↗
• MalfunctionMay 21, 2021Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE DISTAL END OF THE PROBE TIP BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867216 ↗
• MalfunctionMay 14, 2021Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHILE CLEANING CHARRED TISSUE FROM THE PROBE THE TIP BROKE OFF. THE CASE WAS COMPLETED WITH A SINGLE PROBE AND NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826806 ↗
• InjuryAug 1, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ABLATION ON AN OSTEOID OSTEOMA, THE DOCTOR'S PARTNER WAS DRILLING INTO THE BONE, MANUALLY. IN ORDER TO GET TO THE LESION MORE ACCURATELY, THE DOCTOR'S PARTNER TORQUED THE DRILL/CANNULA. WHEN PLACING THE PROBE, THE SAME TECHNIQUE WAS APPLIED TO THE PROBE AFTER THE DRILL WAS REMOVED. DUE TO THE STRAIN ON THE PROBE, IT BROKE. THE PROBE WAS NOT RETRIEVABLE BY THE STAFF. THE DOCTOR CONTACTED AN ORTHOPEDIC SURGEON BY PHONE FOR ADVICE ABOUT HOW TO REMOVE THE PROBE. THE DOCTOR DECIDED TO REMOVE THE PROBE IN THE OR WITH THE ORTHOPEDIC SURGEON THE FOLLOWING DAY. AN ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THE BROKEN PROBE PIECE BEING LEFT IN THE PATIENT'S BODY.

  Patient problems: No Code Available

  MAUDE report 8852125 ↗
• InjuryMar 18, 2019Fracture

  IT WAS REPORTED VIA LITERATURE ENTITLED: MICROWAVE ABLATION OF OSTEOID OSTEOMA: SAFETY AND EFFICACY. AUTHOR(S): V. GIOIOSO, S. REIS, S. BREJT, S. TULIN-SILVER, D. SPERLING, J. SUSMAN, J. WEINTRAUB, D. MOBLEY. CITATION: JVIR SCIENTIFIC E-POSTERS; S243. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF CT-GUIDED MICROWAVE ABLATION (MWA) OF OSTEOID OSTEOMAS. FROM 2014 TO 2017, 24 PATIENTS UNDERWENT MWA FOR OSTEOD OSTEOMAS. A SINGLE PR MICROWAVE ANTENNA ABLATION PROBE (NEUWAVE MEDICAL) WAS PLACED IN A COAXIAL MANNER INTO THE NIDUS. SERIAL MICROWAVE ABLATIONS WERE PERFORMED, PER PROTOCOL. COMPLICATION INCLUDED PROBE FRACTURING IN THE LESION DURING POSITIONING REQUIRED SURGICAL REMOVAL OF THE PROBE TIP AS WELL AS THE OSTEOID OSTEOMA DUE TO CONTINUED PAIN. THERE WERE NO DOCUMENTED POSTPROCEDURAL COMPLICATIONS OF POST BIOPSY OR POST-MWA HEMATOMA OR INFECTION CT-GUIDED MICROWAVE ABLATION IS A WELL-TOLERATED, SAFE AND EFFECTIVE TREATMENT OF OSTEOID OSTEOMA.

  Patient problems: No Code Available; Pain

  MAUDE report 8428998 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: MICROWAVE ABLATION OF OSTEOID OSTEOMA: INITIAL EXPERIENCE AND EFFICACY. AUTHOR(S): ELLIOT S. RINZLER, GIRIDHAR M. SHIVARAM, DENNIS W. SHAW, ERIC J. MONROE, KEVIN S. H. KOO. CITATION: HTTPS://DOI.ORG/10.1007/S00247-018-4327-1. THE PURPOSE OF THIS STUDY WAS TO RETROSPECTIVELY EVALUATE THE TECHNICAL FEASIBILITY AND CLINICAL EFFICACY OF MICROWAVE ABLATION IN THE TREATMENT OF PEDIATRIC OSTEOID OSTEOMAS. BETWEEN JANUARY 1, 2015, AND MAY 31, 2018, 24 PEDIATRIC PATIENTS, AGE RANGE: 3-18; MALE: 15, FEMALE: 9 WERE EVALUATED AND INCLUDED IN THIS STUDY. DURING THE PROCEDURE, THE CORING NEEDLE WAS THEN REMOVED AND THE 17-GAUGE NEUWAVE PR ANTENNA (ETHICON US, LLC, SOMERVILLE, NJ) WAS ADVANCED JUST BEYOND THE DISTAL EDGE OF THE LESION TO COVER THE ENTIRE NIDUS WITHIN THE ANTENNA¿S ABLATION ZONE. A MINIMUM OF THREE ABLATION CYCLES WERE PERFORMED AT A POWER SETTING OF 30 WATTS, WITH A TARGET TEMPERATURE OF 90 DEGREES CELSIUS AND A 30-S COOLING PERIOD BETWEEN CYCLES. EACH ABLATION CYCLE LASTED 30 S. MINOR COMPLICATIONS WERE SEEN IN 4/24 (17%) PATIENTS. THESE INCLUDED 3 PATIENTS WITH LOCAL SKIN NUMBNESS IN THE REGION OF THE ACCESS SITE (CLASS A COMPLICATION, T

  Patient problems: Hypoesthesia; Tissue Damage; Unspecified Infection

  MAUDE report 8428659 ↗
• MalfunctionJun 22, 2018Leak/Splash

  IT WAS REPORTED BY THE THAT DURING AN UNKNOWN ABLATION PROCEDURE, THE DOCTOR HAD A 20 CM 17G PROBE WITH A LEAK. HE DID TEST IT FIRST. THE LEAK WAS DISCOVERED WHILE IN THE PATIENT. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7629960 ↗
• InjuryJun 23, 2017Device Displays Incorrect Message; Temperature Problem

  THE PHYSICIAN WAS USING A 20CM PR PROBE TO PERFORM AN ABLATION. DURING THE CASE, THE PHYSICIAN INDICATED THAT SEVERAL TEMPERATURE ERRORS OCCURRED ON THE PROBE. THE PROBE WAS RETESTED AND PASSED THE TESTS. AFTER THE COMPLETION OF THE PROCEDURE, A BURN WAS NOTICED ON THE PATIENT'S SKIN. NO INFORMATION WAS PROVIDED REGARDING THE SIZE, DEGREE OR REQUIRED TREATMENT OF THE SKIN BURN.

  Patient problems: Burn, Thermal

  MAUDE report 6664709 ↗