NEUWAVE LK15Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00853719006357), received between Mar 12, 2019 and Jul 13, 2022 — classified as 2 deaths, 4 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CLINICAL TRIAL ABLATION, NEU_2017_04, THE PATIENT EXPERIENCED MUSCLE BURN AND PLEURAL EFFUSION. THE DEVICE AND PROCEDURE RELATIONSHIP WITH THE MUSCLE BURN IS CAUSAL. THE DEVICE RELATIONSHIP WITH THE PLEURAL EFFUSION IS NOT RELATED AND THE STUDY PROCEDURE RELATIONSHIP WAS CAUSAL. THE PATIENT RECEIVED DIAGNOSTIC IMAGING AND WAS OBSERVED FOR BOTH CONDITIONS. HE IS FULLY RECOVERED FROM BOTH.

  Patient problems: Burn(s); Pleural Effusion

  MAUDE report 15006158 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LIVER ABLATION, THE PATIENT EXPERIENCED A SKIN BURN. THE BURN WAS BETWEEN A DIME TO THE SIZE OF A NICKEL. THE MIDDLE OF THE BURN WAS A WHITE AND THEN ON THE OUTSIDE IT WAS A PINK REDDISH COLOR. IT WAS PLANNED TO BE A TEN MINUTE BURN. THEY SCANNED INTERMITTENTLY EVERY TWO MINUTES. THEY ENDED UP SEEING SUBCUTANEOUS FAT LEAKAGE. THEY KNEW THAT THEY WERE GETTING CLOSER TO THE SKIN. THEY SHUT OFF THE UNIT AT FIVE MINUTES IN. THEY DID NOT COMPLETE THE TEN MINUTE BURN. AT THE TIME OF THE CALL PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 12778533 ↗
• DeathApr 6, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, A CT SCAN SHOWED PATIENT HAD SUFFERED AN AIR EMBOLISM AND COULD NOT BE REVIVED. THE PATIENT UNDERWENT A LUNG ABLATION FOR 2 LESIONS IN THE LUNG, ONE ABLATION LASTED 7 MIN AND THE SECOND ABLATION LASTED 4 MIN, USING AN LK PROBE. ABLATIONS COMPLETED AS NORMAL, WHEN THE PROCEDURE FINISHED THE PROBE WAS REMOVED FROM THE PATIENT AND DISPOSED OF, THEN A CT SCAN WAS CARRIED OUT. IT WAS NOTED THAT THE PATIENT HAD AN AIR EMBOLISM. THE TEAM THEN TRIED TO RESUSCITATE THE PATIENT, BUT COULD NOT AND THE PATIENT PASSED AWAY.

  Patient problems: Air Embolism; Death

  MAUDE report 9928964 ↗
• DeathNov 22, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A LIVER ABLATION PROCEDURE PERFORMED ON (B)(6) 2019, THE PATIENT REQUIRED TREATMENT FOR A FISTULA BETWEEN THE LUNG AND LIVER. THE PATIENT HAS SINCE DIED. THE PROBE PLACEMENT WAS DESIGNED PRIOR TO THE PROCEDURE SUCH THAT TWO PROBES WOULD BE PLACED PERCUTANEOUSLY TO ABLATE THE LIVER LESION WITHOUT GOING THROUGH LUNG. TWO LK PROBES WERE USED TO ABLATE FOR 10 MINUTES AT 90 WATTS. THERE WERE NO ISSUES WITH PROBES OR THE SYSTEM REPORTED DURING THE CASE. ABLATION CONFIRMATION IMAGING CONFIRMED THAT THE MARGINS WERE SUFFICIENT. THE CAUTERIZE FUNCTION WAS NOT USED DURING PROBE REMOVAL. DAYS AFTER THE PROCEDURE IT WAS FOUND THAT THE PATIENT HAD A FISTULA BETWEEN THE LUNG AND LIVER. DRAINAGE OF THE FLUID COLLECTION AT THE FISTULA WAS PERFORMED FIVE TIMES SUBSEQUENTLY. THE PATIENT PASSED AWAY THREE WEEKS AGO (EXACT DATE WAS NOT KNOWN). THE SURGEON BELIEVES THE ABLATION ZONE WAS LARGER THAN EXPECTED WHICH LED THE PATIENT CONSEQUENCE. THE REP STATED THAT ALTHOUGH THE PLACEMENT OF THE PROBES WAS DESIGNED WITH NO CONTACT WITH THE LUNGS, HE BELIEVES THAT THE PROBE MADE CONTACT DURING PATIENT INSPIRATION. AS THE DIAPHRAGM FLATTENED, THE COSTO-PHRENIC ANGLE MOVED AND TH

  Patient problems: Abscess; Death; Fistula

  MAUDE report 9364257 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: "MICROWAVE ABLATION OF MALIGNANT HEPATIC TUMOURS: INTRAPERITONEAL FLUID INSTILLATION PREVENTS COLLATERAL DAMAGE AND ALLOWS MORE AGGRESSIVE CASE SELECTION." AUTHOR(S): DOUGLAS KITCHIN, MEGHAN LUBNER, TIM ZIEMLEWICZ, J. LOUIS HINSHAW, MARCI ALEXANDER, CHRISTOPHER L. BRACE & FRED LEE. CITATION: INT J HYPERTHERMIA, 2014; 30 (5): 299¿305; DOI: 10.3109/02656736.2014.936050. THIS RETROSPECTIVE STUDY AIMED TO REVIEW OUR EXPERIENCE UTILIZING PROTECTIVE FLUID INSTILLATION TECHNIQUES DURING PERCUTANEOUS MICROWAVE (MW) ABLATION OF LIVER TUMOURS TO DETERMINE IF FLUID INSTILLATION PREVENTS NON-TARGET INJURIES AND ALLOWS A MORE AGGRESSIVE CASE SELECTION. BETWEEN 2008 AND 2012, 151 HEPATIC TUMOURS IN 87 PATIENTS (N=70 MEN AND N=17 WOMEN) UNDERWENT PERCUTANEOUS MW ABLATION PROCEDURES FOR MALIGNANT HEPATIC LESIONS. ONE TO THREE HIGH-POWERED GAS-COOLED ANTENNAS (LK OR PR ANTENNAS, CERTUS 140, NEUWAVE MEDICAL, MADISON, WI) WERE UTILIZED IN EACH PROCEDURE. TWENTY NINE OF 151 UTILIZED FLUID ADMINISTRATION IN WHICH 122 WERE CONSIDERED AS CONTROL GROUP. COMPLICATIONS INCLUDED POSTPROCEDURAL PORTAL VENOUS THROMBUS (N=1), THERMAL INJURY OF THE DIAPHRAGM RESULTING IN

  Patient problems: Injury; Nausea; No Code Available; No Consequences Or Impact To Patient; Pain; Pleural Effusion

  MAUDE report 8444509 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE ENTITLED: EFFECT OF TUMOR COMPLEXITY AND TECHNIQUE ON EFFICACY AND COMPLICATIONS AFTER PERCUTANEOUS MICROWAVE ABLATION OF STAGE T1A RENAL CELL CARCINOMA: A SINGLE-CENTER, RETROSPECTIVE STUDY. AUTHORS: MARKI E. KLAPPERICH, BS, E. JASON ABEL, MD, TIMOTHY J. ZIEMLEWICZ, MD, SARA BEST, MD, MEGHAN G., LUBNER, MD, STEPHEN Y. NAKADA, MD, J. LOUIS HINSHAW, MD, CHRISTOPHER L. BRACE, PHD, FRED T. LEE, JR, MD AND SHANE A. WELLS, MD. CITATION: RADIOLOGY: VOLUME 284: 272¿280, NUMBER 1¿JULY 2017; HTTPS://DOI.ORG/10.1148/RADIOL.2016160592. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE EFFECTS OF TUMOR COMPLEXITY AND TECHNIQUE ON EARLY AND MIDTERM ONCOLOGIC EFFICACY AND THE RATE OF COMPLICATIONS FOR 100 CONSECUTIVE BIOPSY-PROVED STAGE T1A RENAL CELL CARCINOMA (RCC) TUMORS TREATED WITH PERCUTANEOUS MICROWAVE ABLATION. RCC WHO UNDERWENT MICROWAVE ABLATION FROM MARCH 2011, THE INCEPTION OF OUR MICROWAVE ABLATION PROGRAM, TO JUNE 2015 WAS IDENTIFIED FROM AN INSTITUTIONAL DATABASE. MEAN AGE: 66 +/- 9.4 (44¿87); M 68/96 (70.8). F 28/96 (29.2). DURING THE PROCEDURE, A 2.45-GHZ, GAS-COOLED MICROWAVE ABLATION SYSTEM WITH 17-GAUGE ANTENNAS THAT CAN BE POWERED SIM

  Patient problems: Blood Loss; Hematoma; Hematuria

  MAUDE report 8411893 ↗