Edison EDNTC1001 (UDI 00850006962082)Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00850006962082), received between Jun 18, 2025 and Sep 21, 2026 — classified as 4 deaths, 39 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pneumothorax

  MAUDE report 50847380 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50847376 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, a 69-year-old female with a history of multifocal hepatocellular carcinoma secondary to NASH cirrhosis underwent histotripsy of liver tumors in segments IVB and II for a total planned treatment volume (PTV) of approximately 83.1 cc. The procedure was reported as uneventful, and the patient was admitted for planned post-procedure monitoring. Immediate post-procedure CT demonstrated thrombosis of the recanalized umbilical vein. The patient developed hyperbilirubinemia, transaminitis, lethargy, and chills. Total bilirubin increased from 1.7 mg/dL to a peak of 13.1 mg/dL at approximately 12 hours post procedure, with AST and ALT of approximately 800 U/L. MRCP demonstrated edema along the left bile duct adjacent to the treatment volume.The patient was managed conservatively with laboratory monitoring every six hours; no transfusion, embolization, or biliary intervention was required. She remained hospitalized until postoperative day 7 and was discharged with bilirubin improved to 2.7 mg/dL. Antibiotics were administered for seven days, and Eliquis was continued.

  Patient problems: Chills; Hyperbilirubinemia; Lethargy; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 50819038 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, a 59-year-old female patient with a history of colorectal cancer metastatic to the liver received histotripsy treatment to a single lesion in liver segment VI which was treated with two overlapping histotripsy planned treatment volumes (PTV) for a total PTV of 67 cc. Patient had previous histotripsy to the same tumor on (b)(6) 2025. The treating physician elected to modify/adjust the histotripsy treatment parameters, including depth (e.g., mark distance from the body wall to target), and implemented manual cooling time. Post-procedure, the patient developed hemorrhagic shock and was admitted to the ICU the same day. Post-procedural CT showed subcapsular hepatic hematoma with bleeding into the peri-nephric fat. Of note, the treating physician disclosed that the tumor may have extended beyond the liver capsule. The patient received a transfusion of two (2) units of packed red blood cells, and vasopressor support. The patient was discharged in stable condition on (b)(6) 2026 and as of (b)(6) 2026, they have fully recovered with normalization of labs.

  Patient problems: Hematoma

  MAUDE report 50202094 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, a 64 year old female patient with a history of colorectal cancer metastatic to the liver received histotripsy treatment to one lesion in hepatic segment II was treated with two overlapping histotripsy planned treatment volumes (PTVs) for a total PTV of approximately 55.6 cc. Post-procedure imaging revealed left portal vein thrombus and left hepatic infarction. Anti-coagulation therapy was initiated, but no antibiotics were prescribed. On (b)(6), the patient was admitted for abscess involving the left hepatic lobe and a course of IV antibiotics was initiated. A drain was placed on (b)(6) and the patient was discharged on (b)(6). On (b)(6), the patient presented to the emergency department, ultimately resulting in admission. The patient subsequently underwent surgical resection on (b)(6) involving hepatic segments II and III to address the abscess. During surgery it was noted that the abscess extended to the abdominal wall. The patient was discharged on (b)(6) with continued home antibiotics and a new drain in place. On (b)(6), the patient had completed antibiotics, but the drain remained in place. Follow-up with Infectious Disease is scheduled for the week on (b)(6).

  Patient problems: Abscess; Thrombosis/Thrombus

  MAUDE report 50184464 ↗
• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, AN (B)(6) YEAR OLD FEMALE WITH A HISTORY OF BREAST CANCER AND HCC PREVIOUSLY TREATED WITH CHEMOTHERAPY AND EXTENSIVE RADIOEMBOLIZATION RECEIVED A SINGLE HISTOTRIPSY TREATMENT TO A TUMOR IN SEGMENT III (ALONG THE PORTAL VEIN) FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF APPROXIMATELY 14.1 CC. PER THE TREATING PHYSICIAN, HER PREVIOUS RADIOEMBOLIZATIONS WERE NOT DIRECTLY OVERLAPPING WITH THE HISTOTRIPSY PTV. HER PLATELET COUNT WAS STABLE AND SHE WAS NOT ON ANTI-COAGULATION PRIOR TO THE PROCEDURE. THE LIVER CAPSULE WAS NOT COMPROMISED, BUT THE HISTOTRIPSY PTV DID OVERLAP THE CAPSULE. PRIOR TO HISTOTRIPSY DELIVERY, THE PATIENT WAS GIVEN 3000 UNITS OF HEPARIN. WHEN SHE AWOKE FROM ANESTHESIA, SHE HAD SEVERE ABDOMINAL PAIN (MORE THAN TYPICALLY OBSERVED). ABDOMEN WAS SOFT BUT TENDER IN THE TREATED REGION AND CT SCAN SHOWED HEMOPERITONEUM. THE BLEEDING APPEARED TO EXTEND FROM THE SITE OF THE HISTOTRIPSY TREATMENT ZONE. NO PSEUDOANEURYSMS WERE OBSERVED. SHE HAD MILD HYPOXIA, REQUIRED OXYGEN AND RECEIVED A UNIT OF BLOOD RESULTING IN NORMALIZATION OF HEMOGLOBIN. SHE WAS DISCHARGED POST-PROCEDURE DAY 5 WITHOUT FURTHER INTERVENTION AND HAS FULLY RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25766113 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, AS PART OF THE BOOMBOX POST-MARKET CLINICAL STUDY, A (B)(6)-YEAR-OLD FEMALE PATIENT WITH METASTATIC BREAST CANCER TO THE LIVER, RECEIVED A HISTOTRIPSY TREATMENT TO TWO TUMORS IN LIVER SEGMENTS V AND VIII FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF APPROXIMATELY 47.6 CC. THE PATIENT WAS DISCHARGED PRIOR TO EVALUATION OF THE POST-PROCEDURE IMAGING. THE FOLLOWING MORNING, A NURSE FROM THE TREATING FACILITY CALLED THE PATIENT TO CHECK IN AND THE PATIENT REPORTED DIZZINESS, SHORTNESS OF BREATH WITH EXERTION, INTERMITTENT PALPITATIONS, CHEST DISCOMFORT, WEAKNESS, AND FATIGUE. THE PATIENT'S SPOUSE REPORTED A HOME BLOOD PRESSURE OF 98/53 MMHG WITH A HEART RATE OF 108 BPM. THE PATIENT WAS DIRECTED TO SEEK EMERGENCY EVALUATION AND UPON PRESENTATION TO THE EMERGENCY DEPARTMENT (ED), THEY WERE ADMITTED. VITAL SIGNS ON ADMISSION INCLUDED A BLOOD PRESSURE OF 88/57 MMHG AND PULSE OF 116 BPM. THE POST-PROCEDURE IMAGING INDICATED A SUBCAPSULAR HEPATIC HEMATOMA. THE PATIENT WAS PLACED ON A SEPSIS PATHWAY AND RECEIVED INTRAVENOUS FLUIDS AND 500 ML OF PACKED RED BLOOD CELLS THE PATIENT WAS DISCHARGED THE SAME DAY FROM THE ED FOLLOWING OBSERVATION. THE PATIENT CONTINUED TO EXPERIENCE

  Patient problems: Atrial Fibrillation; Hematoma

  MAUDE report 25641994 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A 76-YEAR-OLD MALE WITH A HISTORY OF METASTATIC RENAL CELL CARCINOMA, INCLUDING PANCREATIC AND LIVER METASTASES, UNDERWENT HISTOTRIPSY TREATMENT TO MULTIPLE LIVER TUMORS AND A SINGLE PANCREAS TUMOR. THE PANCREAS LESION MEASURED APPROXIMATELY FIVE (5) CM, WHICH WAS TREATED WITH AN ESTIMATED TOTAL PLANNED TREATMENT VOLUME (PTV) OF 33 CC, FOR THE PURPOSES OF DEBULKING. THE TUMOR WAS DESCRIBED BY THE TREATING PHYSICIAN AS HIGHLY VASCULAR. APPROXIMATELY ONE MONTH AFTER TREATMENT, THE PATIENT DEVELOPED ABDOMINAL PAIN AND PRESENTED TO A LOCAL HOSPITAL ON (B)(6). ABDOMINAL IMAGING INDICATED A PSEUDOANEURYSM IN THE PANCREAS, THE PATIENT UNDERWENT EMBOLIZATION ON (B)(6). PERSISTENT BLEEDING WAS SUBSEQUENTLY IDENTIFIED, AND A REPEAT EMBOLIZATION WAS PERFORMED ON (B)(6). DUE TO HEMOGLOBIN DECLINE AND CONTINUED CONCERN FOR BLEEDING, EMPIRIC SBRT WAS ALSO PERFORMED. THE PATIENT WAS MONITORED CLOSELY FOLLOWING THESE INTERVENTIONS AND WAS DISCHARGED PRIOR TO FOLLOW-UP. AT FOLLOW-UP ON (B)(6), THE PATIENT WAS REPORTED TO BE DOING WELL, WITH NO FURTHER EVIDENCE OF BLEEDING AND EXHIBITED CONTINUED CLINICAL IMPROVEMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25538685 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026 A FEMALE PATIENT WITH A HISTORY OF COLORECTAL CANCER METASTATIC TO THE LIVER, RECEIVED HISTOTRIPSY TREATMENT TO A SINGLE LESION IN SEGMENT IV CONSISTING OF FOUR OVERLAPPING MAXIMUM PLANNED TREATMENT VOLUMES (PTV) FOR A TOTAL PTV OF APPROXIMATELY 134 CC. GIVEN THE TREATMENT VOLUME, THE TREATING PHYSICIAN WAS AWARE OF THE POTENTIAL RISK FOR ACUTE KIDNEY INJURY (AKI) AND IMPLEMENTED PREVENTIVE MEASURES DURING THE PROCEDURE, INCLUDING PLACEMENT OF A FOLEY CATHETER, ADMINISTRATION OF INTRAVENOUS FLUIDS THROUGHOUT THE PROCEDURE, MONITORING OF URINE OUTPUT, AND CLOSE BLOOD PRESSURE MONITORING. DURING THE PROCEDURE, THE PATIENT EXPERIENCED LOW URINE OUTPUT BUT WAS OTHERWISE CLINICALLY STABLE ACCORDING TO THE TREATING PHYSICIAN. FOLLOWING TREATMENT, THE PATIENT WAS ADMITTED FOR OBSERVATION DUE TO ELEVATED CREATININE LEVELS. NEITHER THE BASELINE NOR POST-PROCEDURE CREATININE VALUES WERE AVAILABLE AT THE TIME OF FILING, SO IT IS UNCLEAR IF THIS EVENT WAS AN AKI. THE PATIENT REMAINED HOSPITALIZED FOR OBSERVATION AND SUPPORTIVE CARE; RENAL FUNCTION REMAINED STABLE WITHOUT THE NEED FOR DIALYSIS OR OTHER INTERVENTION. THE PATIENT WAS DISCHARGED ON (B)(6).

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 25538684 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2026, A 55-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF NEUROENDOCRINE CANCER METASTATIC TO THE LIVER RECEIVED HISTOTRIPSY TREATMENT TO A SINGLE LESION IN SEGMENT VII FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF APPROXIMATELY 22.4 CC. POST-PROCEDURE CT IMAGING DEMONSTRATED CONTRAST POOLING CONTAINED WITHIN THE TREATMENT ZONE, INDICATING POTENTIAL INTRAPARENCHYMAL HEMORRHAGE AND THE PATIENT WAS ADMITTED FOR OBSERVATION. FOLLOWING THE PROCEDURE, THE PATIENT'S HEMOGLOBIN DECREASED TO 6.7 G/DL AND THE PATIENT RECEIVED TWO UNITS OF PACKED RED BLOOD CELLS (PRBCS) SHORTLY AFTER MIDNIGHT ON MAY 14TH, FOLLOWED BY AN ADDITIONAL UNIT OF PRBCS ON MAY 15TH. HEMOGLOBIN IMPROVED TO 10.1 G/DL, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION ON MAY 16TH. THE PATIENT HAD A HISTORY OF PRIOR PEPTIDE RECEPTOR RADIONUCLIDE THERAPY (PRRT) WHICH THE TREATING PHYSICIAN BELIEVED MAY HAVE CONTRIBUTED TO THE EVENT.

  Patient problems: Intra-Abdominal Hemorrhage

  MAUDE report 25488427 ↗
• DeathMay 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, AS PART OF THE BOOMBOX POST-MARKET CLINICAL STUDY, A 65-YEAR-OLD MALE PATIENT WITH METASTATIC PANCREATIC ADENOCARCINOMA UNDERWENT HISTOTRIPSY TREATMENT TO FOUR LIVER LESIONS LOCATED IN SEGMENTS II, III, VI, AND VII, FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF APPROXIMATELY 102.5 CC. THE CLINICAL STUDY SITE RECEIVED POST-MORTEM NOTIFICATION THROUGH THE EMR NOTING THAT THE PATIENT PASSED AWAY AT HOME ON (B)(6). THE DEATH NOTIFICATION DOCUMENTED THAT THE PATIENT HAD A 15-MONTH HISTORY OF METASTATIC PANCREATIC CANCER AND PASSED AWAY AT HOME WITH FAMILY PRESENT. PER THE TREATING PHYSICIAN, THE PATIENT WAS IN A CLINICALLY DIFFICULT SITUATION WITH PROGRESSIVE MALIGNANCY AND POSSIBLE CHRONIC LIVER FAILURE. THE PHYSICIAN NOTED THAT THE PATIENT'S DEATH MAY HAVE BEEN CAUSED BY PROGRESSION OF DISEASE AND/OR UNDERLYING LIVER DISEASE. HOWEVER, BECAUSE THE DEATH OCCURRED WITHIN 30 DAYS OF THE INTERVENTION, THE PHYSICIAN WAS UNABLE TO DEFINITIVELY ATTRIBUTE THE DEATH SOLELY TO THE PATIENT'S CHRONIC DISEASE OR TO THE INTERVENTION. THEREFORE, THE EVENT WAS ASSESSED AS "POSSIBLY RELATED" TO THE HISTOTRIPSY TREATMENT PROCEDURE AND "POSSIBLY RELATED" TO THE HISTOSONICS HISTOTRIPSY DEV

  Patient problems: Insufficient Information

  MAUDE report 25322385 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  AS PART OF THE BOOMBOX CLINICAL STUDY, A 54-YEAR-OLD MALE PATIENT WITH A HISTORY OF METASTATIC COLON CANCER RECEIVED HISTOTRIPSY TREATMENT TO THREE TUMORS IN SEGMENTS 3, 4, AND 6, WITH A TOTAL PLANNED TREATMENT VOLUME (PTV) OF APPROXIMATELY 53.7 CC ON (B)(6) 2026. IV CONTRAST CT SCAN FOLLOWING HISTOTRIPSY SHOWED ADEQUATE TUMOR COVERAGE WITH HISTOTRIPSY WITH NO OTHER FINDINGS. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AROUND MIDNIGHT THE SAME DAY WITH PAIN, NAUSEA, AND EMESIS. A SECOND CT SCAN WITH CONTRAST WAS ORDERED (APPROXIMATELY SIX HOURS AFTER THE PRIOR CONTRAST STUDY). THE PATIENT'S CREATININE WAS ELEVATED TO 2.4 MG/DL JUST PRIOR TO THE CT SCAN. FOLLOWING THE SECOND CT WITH IV CONTRAST, THE PATIENT'S CREATININE INCREASED TO 5.29 MG/DL. THE PATIENT WAS HOSPITALIZED FOR SIX DAYS AND WAS MEDICALLY MANAGED AND MONITORED. RENAL FUNCTION SUBSEQUENTLY IMPROVED WITHOUT THE NEED FOR DIALYSIS. AT DISCHARGE, CREATININE DECREASED TO 2.7 MG/DL.

  Patient problems: Renal Impairment

  MAUDE report 25306554 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A 44-YEAR-OLD MALE PATIENT WITH A HISTORY OF UVEAL MELANOMA METASTATIC TO THE LIVER RECEIVED HISTOTRIPSY TREATMENT TO TWO RIGHT HEPATIC TUMORS IN SEGMENT 6, WITH THE LARGER TUMOR REQUIRING AN OVERLAPPING TREATMENT. NO IMMEDIATE PROCEDURAL COMPLICATIONS WERE REPORTED. IMMEDIATE POST-HISTOTRIPSY ULTRASOUND DEMONSTRATED A HETEROGENEOUS APPEARANCE OF THE TREATED LESIONS, AND THE MAIN PORTAL VEIN WAS DOCUMENTED AS PATENT. ON (B)(6), THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER A SYNCOPAL EPISODE, WITH WORSENING RIGHT-SIDED ABDOMINAL PAIN, LIGHTHEADEDNESS, NAUSEA, AND URINARY RETENTION FOLLOWING THE HISTOTRIPSY PROCEDURE, RESULTING IN ADMISSION. INITIAL EVALUATION DOCUMENTED SYMPTOMATIC ANEMIA AND CONCERN FOR LIVER HEMORRHAGE. CT ABDOMEN/PELVIS WITH IV CONTRAST DEMONSTRATED A LARGE HEPATIC AND PERIHEPATIC HEMATOMA, BELIEVED TO BE LIKELY FROM A HYPERATTENUATING LESION IN THE RIGHT HEPATIC LOBE, WITH MODERATE-VOLUME BLOOD PRODUCTS ALONG THE RIGHT PARACOLIC GUTTER AND EXTENDING INTO THE PELVIS. IMAGING ALSO NOTED TWO SCATTERED FOCI OF HYPERDENSE CONTRAST CONSISTENT WITH ACTIVE HEMORRHAGE, THOUGH NO LARGE BRANCH-VESSEL EXTRAVASATION WAS IDENTIFIED. DURING ADMISSION

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25306386 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A 53-YEAR-OLD FEMALE WITH METASTATIC RENAL CELL CARCINOMA UNDERWENT HISTOTRIPSY TO ONE LESION IN LIVER SEGMENT VI (5.6 X 5.8 CM TUMOR DIMENSION; THREE OVERLAPPING TREATMENT VOLUMES). ON (B)(6 2026), THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH WORSENING RIGHT-SIDED ABDOMINAL AND BACK PAIN, ALONG WITH NAUSEA, VOMITING, AND CONSTIPATION AND WAS ADMITTED. LABORATORY RESULTS SHOWED MILDLY ELEVATED LIVER ENZYMES (ALT 123, AST 74), WITH NORMAL WHITE BLOOD CELL COUNT (6.0), LOW PROCALCITONIN (0.1), AND NORMAL LACTATE (0.7). HEMOGLOBIN DECREASED TO 11.4 G/DL FROM THE BASELINE VALUE OF 12.2 G/DL. CT IMAGING SHOWED A LARGE NECROTIC MASS IN THE RIGHT LIVER (SEGMENTS VI/VII), MEASURING APPROXIMATELY 10 X 7.7 X 14 CM, WITH INTERNAL GAS AND SMALL AREAS THAT COULD REPRESENT MINOR BLEEDING. FINDINGS WERE CONSIDERED LIKELY RELATED TO POST-TREATMENT CHANGES. THE PATIENT WAS DISCHARGED ON (B)(6) 2026. MRI ON (B)(6) 2026 SHOWED A LARGE FLUID-FILLED AREA AT THE TREATMENT SITE. ON (B)(6) 2026, A PERCUTANEOUS DRAIN WAS PLACED, WITH OUTPUT CONSISTENT WITH LIQUEFIED HEMATOMA. NO BLOOD TRANSFUSIONS WERE REQUIRED, AND NO HEMODYNAMIC INSTABILITY OCCURRED. PER THE TREATING PHYSICIAN,

  Patient problems: Abdominal Pain; Constipation; Hematoma; Nausea; Vomiting

  MAUDE report 24984612 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A 60-YEAR-OLD MALE PATIENT, ENROLLED INTO THE BOOMBOX STUDY WITH A HISTORY OF METASTATIC COLORECTAL CANCER TO THE LIVER, UNDERWENT HISTOTRIPSY TREATMENT. A SINGLE HEPATIC LESION WAS TREATED IN SEGMENT VIII. THE TREATMENT COMPRISED TWO OVERLAPPING PLANNED TREATMENT VOLUMES (PTVS) FOR A TOTAL TREATMENT VOLUME OF APPROXIMATELY 67CC. THE PATIENT HAD PRIOR CHEMOTHERAPY, Y90 RADIOEMBOLIZATION THERAPY TO BOTH HEPATIC LOBES IN 2023, AND HISTOTRIPSY TO SEGMENT V/VIII ON (B)(6) 2026. IN THE INTERVAL BETWEEN HISTOTRIPSY TREATMENTS (B)(6), THE PATIENT UNDERWENT HEPATIC ARTERY INFUSION (HAI) PUMP TREATMENT WITH FLOXURIDINE (FUDR) THERAPY. THE PATIENT HAD CONTINUED DISEASE PROGRESSION WITH SIGNIFICANT TUMOR BURDEN AND COMPROMISED LIVER FUNCTION PRIOR TO THE SECOND HISTOTRIPSY PROCEDURE. POST-PROCEDURALLY, THE PATIENT DEVELOPED FEVER AND WAS ADMITTED ON (B)(6) FOR FURTHER EVALUATION. BLOOD CULTURES WERE POSITIVE FOR CLOSTRIDIUM SPECIES, AND THE CLINICAL PRESENTATION WAS CONSISTENT WITH CHOLANGITIS WITH ASSOCIATED BACTEREMIA. CT IMAGING ON THE DAY OF ADMISSION SHOWED A LESION WITH GAS IN THE RIGHT SIDE OF THE LIVER, LIKELY RELATED TO THE HISTOTRIPSY TREATMENT. IT ALSO SHOWED THICKE

  Patient problems: Bacteremia; Cholangitis; Fatigue; Fever; Hyperphosphatemia

  MAUDE report 24958724 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A 51-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF COLORECTAL CANCER WITH LIVER METASTASES UNDERWENT HISTOTRIPSY TREATMENT TO A SINGLE HEPATIC LESION IN SEGMENT V FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 33.5 CC. PATIENT WAS ON NSAIDS PRIOR TO TREATMENT AND HAD A CT SCAN WITH CONTRAST IMMEDIATELY POST PROCEDURE. THE PATIENT DEVELOPED ACUTE RENAL FAILURE, PRESENTED WITH LOWER EXTREMITY EDEMA AND WAS HYPERTENSIVE (NO PRIOR HISTORY) WHEN ADMITTED ON (B)(6). LABORATORY EVALUATION DEMONSTRATED A PEAK CREATININE OF 11 MG/DL. THE PATIENT DID NOT REQUIRE DIALYSIS. A KIDNEY BIOPSY WAS PERFORMED, WITH PATHOLOGY FINDINGS CONSISTENT WITH ACUTE INTERSTITIAL NEPHRITIS (AIN), WHICH WAS ASSESSED AS LIKELY MEDICATION-(NSAIDS) INDUCED. THE PATIENT WAS DISCHARGED ON (B)(6) AND RENAL FUNCTION SUBSEQUENTLY IMPROVED, WITH THE MOST RECENT CREATININE REPORTED AT 1.38 MG/DL ON (B)(6), AND NORMALIZED TO 0.9 AS OF (B)(6).

  Patient problems: High Blood Pressure/ Hypertension; Renal Impairment; Swelling/ Edema

  MAUDE report 24957481 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2026, A 52-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF METASTATIC GRANULOSA CELL TUMOR INVOLVING THE LIVER RECEIVED HISTOTRIPSY TO MULTIPLE HEPATIC LESIONS IN SEGMENTS II, III, AND VI, FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 52.48 CC. ONE OF THE TUMORS TARGETED WAS ADJACENT TO THE STOMACH. THE PATIENT HAD AN EXTENSIVE ONCOLOGIC AND SURGICAL HISTORY, INCLUDING PRIOR TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (TAH/BSO), MULTIPLE HEPATIC RESECTIONS, PERITONEAL DEBULKING PROCEDURES, AND MULTIPLE LINES OF SYSTEMIC THERAPY. RADIOLOGY REVIEW OF IMMEDIATE POST-TREATMENT IMAGING INDICATED "POST-TREATMENT CHANGES IN THE LIVER [WITH] INFLAMMATORY CHANGES EXTEND[ING] FROM SEGMENT II/III TO THE GASTRIC WALL AND OBLITERATION THE FAT PLANE [BETWEEN THE LIVER AND STOMACH]", WHICH WAS BELIEVED TO BE A SUPERFICIAL INJURY TO THE STOMACH. FOLLOWING DISCHARGE FROM THE POST-ANESTHESIA CARE UNIT, THE PATIENT DEVELOPED PERSISTENT BACK AND UPPER ABDOMINAL PAIN AND SHORTNESS OF BREATH, PROMPTING PRESENTATION TO AN OUTSIDE EMERGENCY DEPARTMENT ON POD0. IMAGING AT THAT TIME DEMONSTRATED A FOCAL DISRUPTION OF THE LATERAL WALL OF THE STOMACH WITH ADJACENT EXTRALUMINAL AIR A

  Patient problems: Abdominal Pain; Back pain; Dyspnea; Perforation

  MAUDE report 24905557 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A 70-YEAR-OLD MALE WITH A HISTORY OF GASTROINTESTINAL STROMAL TUMOR (GIST) UNDERWENT A SECOND HISTOTRIPSY PROCEDURE TARGETING A HEPATIC LESION IN SEGMENT V, CONSISTING OF THREE OVERLAPPING TREATMENTS FOR DEBULKING OF A 10 CM LESION (TOTAL ESTIMATED PLANNED TREATMENT VOLUME (PTV) OF 100.5 CC). THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR CONGESTIVE HEART FAILURE (CHF), DIABETES MELLITUS, AND END-STAGE RENAL DISEASE ON DIALYSIS. POST-PROCEDURALLY, THE PATIENT EXPERIENCED OXYGEN DESATURATION IN THE POST-ANESTHESIA CARE UNIT, AND IMAGING DEMONSTRATED PULMONARY EDEMA. THE PATIENT WAS ADMITTED TO THE ICU, KEPT OVERNIGHT FOR OBSERVATION, SUBSEQUENTLY STABILIZED AND WAS DISCHARGED. THE TREATING PHYSICIAN ATTRIBUTED THE EDEMA TO A COMBINATION OF POTENTIAL OVERLOAD OF PERI-OPERATIVE FLUIDS, ANESTHESIA PROTOCOL (INCLUDING POSSIBLE HYPERCAPNIA OR NARCOTIC EFFECT) AND PREMATURE REMOVAL FROM INTUBATION. ACCORDING TO THE TREATING PHYSICIAN, THE EVENT WAS NOT RELATED TO THE DEVICE OR SITE OF HISTOTRIPSY.

  Patient problems: Pulmonary Edema

  MAUDE report 24834918 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A 41 YEAR OLD FEMALE PATIENT WITH A HISTORY OF COLORECTAL CANCER WITH HEPATIC METASTASES RECEIVED HISTOTRIPSY TREATMENT TO ONE HEPATIC LESION IN SEGMENT VII FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 33.5 CC. THE PATIENT ALSO RECEIVED INTRAVENOUS FLUID RESUSCITATION, INCLUDING APPROXIMATELY 1 L OF LACTATED RINGER'S SOLUTION PRE-OPERATIVELY AND AN ESTIMATED 1.5 L INTRA-OPERATIVELY. ON POST-OPERATIVE DAY 1, THE PATIENT DEVELOPED ACUTE KIDNEY INJURY (AKI) AND WAS SUBSEQUENTLY ADMITTED FOR INPATIENT MANAGEMENT AND WAS DISCHARGED ON (B)(6).

  Patient problems: Renal Impairment

  MAUDE report 24778090 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A PATIENT WITH A HISTORY OF NEUROENDOCRINE TUMOR (NET) RECEIVED HISTOTRIPSY TREATMENT TO TWO HEPATIC TUMORS IN SEGMENTS II AND III FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 43.3 CC. NO HEMATURIA WAS OBSERVED DURING THE PROCEDURE. THE PATIENT HAD NO REPORTED PRIOR HISTORY OF RENAL DISEASE OR KNOWN RENAL RISK FACTORS. ON THE DAY OF THE PROCEDURE, THE PATIENT WAS FOUND TO HAVE ACUTE KIDNEY INJURY (AKI) AND WAS ADMITTED FOR INPATIENT MANAGEMENT. THE PATIENT REMAINED HOSPITALIZED FOR APPROXIMATELY ONE WEEK. DURING HOSPITALIZATION, THE PATIENT REQUIRED TWO SESSIONS OF DIALYSIS, AFTER WHICH RENAL FUNCTION IMPROVED, AND THE AKI RESOLVED.

  Patient problems: Renal Impairment

  MAUDE report 24714804 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A 61-YEAR-OLD MALE WITH A HISTORY OF STAGE IV LEFT-SIDED COLON CANCER WITH METACHRONOUS LIVER METASTASES RECEIVED HISTOTRIPSY TREATMENT TO A SINGLE TUMOR IN LIVER SEGMENT 5 FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 17.3 CC. ON (B)(6), THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AND WAS SUBSEQUENTLY ADMITTED FOR EVALUATION OF ELEVATED SERUM CREATININE GREATER THAN 3.5 MG/DL AND SUSPECTED ACUTE KIDNEY INJURY (AKI). THE PATIENT RECEIVED INTRAVENOUS HYDRATION AND RENAL FUNCTION IMPROVED. THE CONDITION RESOLVED WITHOUT ADDITIONAL INTERVENTIONS, AND THE PATIENT WAS DISCHARGED ON (B)(6).

  Patient problems: Renal Impairment

  MAUDE report 24702591 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2026, A MALE PATIENT WITH A HISTORY OF HEPATOCELLULAR CARCINOMA (HCC) RECEIVED HISTOTRIPSY TREATMENT TO A PORTAL VEIN TUMOR THROMBUS IN LIVER SEGMENT 6 FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 73.9 CC. THE PROCEDURE INVOLVED OVERLAPPING HISTOTRIPSY TREATMENTS OF THE PORTAL VEIN THROMBUS. THE TREATING PHYSICIAN REPORTED THAT FOLLOWING TREATMENT, IMAGING DEMONSTRATED RESOLUTION OF THE TUMOR THROMBUS, AND THE PATIENT'S BILIRUBIN LEVELS IMPROVED, CONSISTENT WITH A FAVORABLE LOCAL TREATMENT RESPONSE. ON (B)(6), THE PATIENT PRESENTED TO THE HOSPITAL REPORTING THAT THEY WERE NOT FEELING WELL. LABORATORY EVALUATION DEMONSTRATED ELEVATED SERUM CREATININE OF 4.6 MG/DL, AND THE PATIENT WAS ADMITTED FOR EVALUATION OF ACUTE KIDNEY INJURY. THE PATIENT WAS MANAGED CONSERVATIVELY, DIALYSIS WAS NOT REQUIRED, AND SERUM CREATININE BEGAN TO DECLINE DURING HOSPITALIZATION WITH NO FURTHER SEQUELAE RESULTING IN DISCHARGE ON (B)(6).

  Patient problems: Renal Impairment

  MAUDE report 24690564 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A (B)(6) YEAR OLD MALE PATIENT WITH A HISTORY OF CHOLANGIOCARCINOMA RECEIVED HISTOTRIPSY TREATMENT TO FIVE (5) LESIONS IN LIVER SEGMENT 6 FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 149.5 CC. DARKENING OF THE PATIENT'S URINE WAS OBSERVED INTRA-/POST-PROCEDURALLY, PROMPTING CONSIDERATION OF INCREASED INTRAVENOUS FLUIDS AND DIURETICS. HOWEVER, THE ANESTHESIA TEAM EXPRESSED CONCERN REGARDING FLUID MANAGEMENT DUE TO THE PATIENT'S UNDERLYING CHRONIC CARDIAC CONDITION. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED ON (B)(6) AND REQUIRED TWO SESSIONS OF DIALYSIS. THE PATIENT WAS DISCHARGED ON (B)(6), WITH LABORATORY VALUES HAVING RETURNED TO BASELINE.

  Patient problems: Renal Impairment

  MAUDE report 24622062 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A 79-YEAR-OLD MALE PATIENT WITH A HISTORY OF UVEAL MELANOMA RECEIVED HISTOTRIPSY TREATMENT TO A SINGLE SEGMENT 8 LIVER TUMOR FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 9.6 CC. THE PATIENT HAD SIGNIFICANT COMORBIDITIES INCLUDING CAROTID ARTERY STENOSIS WITH PRIOR STENT PLACEMENT AND AUTOIMMUNE DISEASE, WHICH LIMITED SYSTEMIC TREATMENT OPTIONS. THE TUMOR WAS CAPSULAR IN LOCATION AND MEASURED APPROXIMATELY 1.7 CM AT THE TIME OF TREATMENT. EIGHT DAYS AFTER THE HISTOTRIPSY PROCEDURE, THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND WAS ADMITTED. IMAGING DEMONSTRATED A LARGE PERIHEPATIC HEMATOMA WITHOUT EVIDENCE OF ACTIVE BLEEDING. THE PATIENT WAS MANAGED CONSERVATIVELY AND DISCHARGED THREE DAYS LATER. UPON FOLLOW-UP, THE TREATING PHYSCIAN INDICATED THAT THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: Hematoma

  MAUDE report 24622061 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A 70-YEAR-OLD MALE WITH A HISTORY OF GASTROINTESTINAL STROMAL TUMOR (GIST) RECEIVED HISTOTRIPSY TREATMENT TO ONE HEPATIC LESION IN SEGMENT III OF THE LIVER WITH TWO OVERLAPPING TREATMENTS FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 49 CC. IMMEDIATELY FOLLOWING THE PROCEDURE, POST-PROCEDURE IMAGING DEMONSTRATED A SMALL HEPATIC HEMORRHAGE. DUE TO THE BLEEDING EVENT, THE PATIENT REQUIRED INTERVENTIONAL RADIOLOGY EMBOLIZATION OF TWO BRANCHES OF THE HEPATIC ARTERY TO CONTROL THE HEMORRHAGE. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR MONITORING AND MANAGEMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24622060 ↗