Embosphere® 00884450402948Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00884450402948), received between Dec 19, 2025 and Jul 15, 2026 — classified as 1 death, 31 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K181300); they may or may not involve this specific model.

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 32 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  THIS LITERATURE ARTICLE DESCRIBES MULTIPLE PATIENT EVENTS. SEPARATE COMPLAINT RECORDS AND ASSOCIATED MDRS WERE INITIATED FOR THE ADDITIONAL PATIENTS DESCRIBED IN THE PUBLICATION TO ENSURE ALL POTENTIALLY REPORTABLE EVENTS WERE EVALUATED AND DOCUMENTED APPROPRIATELY. STUDY: BIRN, J., WILLIAMS, T. R., CROTEAU, D., SCHWARTZ, S., STURZA, S., & GETZEN, T. (2013). TRANSARTERIAL EMBOLIZATION OF SYMPTOMATIC FOCAL NODULAR HYPERPLASIA. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 24(11), 1647-1655. HTTPS://DOI.ORG/10.1016/J.JVIR.2013.07.012 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES FOCAL NODULAR HYPERPLASIA (FNH) PROCEDURES THAT HAVE BEEN ASSOCIATED WITH ASYMPTOMATIC DISSECTION OF THE CELIAC ARTERY, POSTEMBOLIZATION SYNDROME, AND CHEST PAIN. THE 3 PATIENTS WITH PES ARE NOT REPORTABLE. "CLINICALLY, 7 OF THE 12 PATIENTS (58%) HAD COMPLETE RESOLUTION OF SYMPTOMS BY THE TIME OF THE FIRST CLINICAL FOLLOW-UP VISIT AFTER EMBOLIZATION, AND 5 PATIENTS (42%) HAD A REDUCTION IN SYMPTOMS AT THE INITIAL OFFICE VISIT AFTER THE PROCEDURE. FOUR PATIENTS HAD CESSATION OF PAIN MEDICATION USE AFTER EMBOLIZATION, AND ONE PATIENT WHO REQUIRED TRANSDERMAL FENTANYL REQU

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Back pain; Fatigue; Fever; Hyperplasia; Ischemic Heart Disease; Pain; Vascular Dissection; Weight Changes

  MAUDE report 25828403 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: ZAITOUN, M. M., BASHA, M. A., ELSAYED, S. B., EL DEEN, D. S., ZAITOUN, N. A., ALTURKISTANI, H., FARAG, A. A., ABDELSALAM, H., EL-KENAWY, H. A., MAHMOUD, N. E., ALAYOUTY, N. A., ELADL, I. M., SHAHIN, S., ALMARZOOQI, M.-K., HENDI, A. M., EL-MORSY, A., & ELMOKADEM, A. H. (2021). COMPARISON OF THREE EMBOLIC MATERIALS AT PARTIAL SPLENIC ARTERY EMBOLIZATION FOR HYPERSPLENISM: CLINICAL, LABORATORY, AND RADIOLOGICAL OUTCOMES. INSIGHTS INTO IMAGING, 12(1). HTTPS://DOI.ORG/10.1186/S13244-021-01030-5 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES THE MICROSPHERES USED IN PARTIAL SPLENIC ARTERY EMBOLIZATION (PSAE) PROCEDURES HAVE BEEN ASSOCIATED WITH PAIN, FEVER, VOMITING, ASCITES, PLEURAL EFFUSION, SPLENIC ABSCESS, HEMATEMESIS, AND PORTAL VEIN THROMBOSIS. GROUP TWO: PATIENTS EXPERIENCED PAIN (49), FEVER (50), VOMITING (22), ASCITES (7), PLEURAL EFFUSION (7), SPLENIC ABSCESS (1), HEMATEMESIS (1), PORTAL VEIN THROMBOSIS (1). SPECIFIC PATIENT DEMOGRAPHICS WERE NOT INCLUDED IN THIS ARTICLE. ONE PATIENT DEVELOPED A SPLENIC ABSCESS MANAGED BY PIGTAIL CATHETER DRAINAGE AND STRONG ANTIBIOTIC COVERAGE. FIVE PATIENTS HAD HEMATEMESIS CONTROLLED BY CONSERVATIVE T

  Patient problems: Abscess; Ascites; Fever; Hematemesis; Hemorrhage/Blood Loss/Bleeding; Pain; Peritonitis; Pleural Effusion; Thrombosis/Thrombus; Vomiting

  MAUDE report 25827203 ↗
• DeathJul 15, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: TENG, Y., DING, X., LI, W., SUN, W., & CHEN, J. (2022). A RETROSPECTIVE STUDY ON THERAPEUTIC EFFICACY OF TRANSARTERIAL CHEMOEMBOLIZATION COMBINED WITH IMMUNE CHECKPOINT INHIBITORS PLUS LENVATINIB IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA. TECHNOLOGY IN CANCER RESEARCH & TREATMENT, 21, 153303382210751. HTTPS://DOI.ORG/10.1177/15330338221075174 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION STATED THAT DURING THE STUDY 2 PATIENTS DIED OF UPPER GASTROINTESTINAL BLEEDING, WHICH WAS OF UNCERTAIN RELATIONSHIP TO THE STUDY TREATMENT.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 25827002 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: TENG, Y., DING, X., LI, W., SUN, W., & CHEN, J. (2022). A RETROSPECTIVE STUDY ON THERAPEUTIC EFFICACY OF TRANSARTERIAL CHEMOEMBOLIZATION COMBINED WITH IMMUNE CHECKPOINT INHIBITORS PLUS LENVATINIB IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA. TECHNOLOGY IN CANCER RESEARCH & TREATMENT, 21, 153303382210751. HTTPS://DOI.ORG/10.1177/15330338221075174, WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES THE MICROSPHERES USED IN TRANSARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURES HAVE BEEN ASSOCIATED WITH HYPERTENSION, PROTEINURIA, PYREXIA, ALT INCREASE, AST INCREASE, CK-MB INCREASE, TBIL INCREASE, HYPOTHYROIDISM, DIARRHEA, PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME, WEIGHT LOSS, DECREASED APPETITE, AND LIPASE INCREASE. ADDITIONALLY, DURING THE STUDY 2 PATIENTS DIED OF UPPER GASTROINTESTINAL BLEEDING, WHICH WAS OF UNCERTAIN RELATIONSHIP TO THE STUDY TREATMENT.

  Patient problems: Decreased Appetite; Diarrhea; Fever; High Blood Pressure/ Hypertension; Hypothyroidism; Unspecified Kidney or Urinary Problem; Weight Changes

  MAUDE report 25825630 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: SALET, E., CROMBÉ, A., GRENIER, N., MARCELIN, C., LEBRAS, Y., JAMBON, E., COUSSY, A., CORNELIS, F. H., & PETITPIERRE, F. (2022). PROSTATIC ARTERY EMBOLIZATION FOR BENIGN PROSTATIC OBSTRUCTION: SINGLE-CENTRE RETROSPECTIVE STUDY COMPARING MICROSPHERES VERSUS N-BUTYL CYANOACRYLATE. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 45(6), 814-823. HTTPS://DOI.ORG/10.1007/S00270-022-03069-3 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES; 1 PATIENT WITH PENIS GLANS NECROSIS "WHICH WAS A TROPHIC DISORDER THAT RESOLVED WITH LOCAL TREATMENTS". 1 PATIENT WITH ERECTILE DYSFUNCTION THAT RESOLVED SPONTANEOUSLY WITHIN MONTHS.

  Patient problems: Erectile Dysfunction; Necrosis

  MAUDE report 25824594 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: SAKUHARA, Y., NISHIO, S., HATTANDA, F., SOYAMA, T., TAKAHASHI, B., ABO, D., & MIMURA, H. (2019). INITIAL EXPERIENCE WITH THE USE OF TRIS-ACRYL GELATIN MICROSPHERES FOR TRANSCATHETER ARTERIAL EMBOLIZATION FOR ENLARGED POLYCYSTIC LIVER. CLINICAL AND EXPERIMENTAL NEPHROLOGY, 23(6), 825-833. HTTPS://DOI.ORG/10.1007/S10157-019-01714-9 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES THAT THE MICROSPHERES USED IN TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) PROCEDURES HAVE BEEN ASSOCIATED WITH BRADYCARDIA AND IT IMPROVED AFTER AN INTRAVENOUS ADMINISTRATION OF ATROPINE. "FROM MARCH 2013 TO MAY 2013, FIVE PATIENTS (FOUR FEMALES, ONE MALE; MEAN AGE 52.6 YEARS, AGE RANGE 35-61 YEARS) WERE ENROLLED. THEIR CHIEF COMPLAINTS WERE MARKEDLY DISTENDED ABDOMEN AND GASTROINTESTINAL OBSTRUCTION CAUSED BY THE ENLARGED POLYCYSTIC LIVER. THE ESTIMATED VOLUME OF THE WHOLE LIVER BEFORE AND AFTER TAE WAS MEASURED USING MRI DATA IN THREE OF THE FIVE PATIENTS. IN THE OTHER TWO PATIENTS, NONCONTRAST-ENHANCED CT IMAGE DATA WERE USED FOR THE MEASUREMENT, BECAUSE THEIR LIVER VOLUMES WERE SO LARGE THAT THE IMAGE QUALITY WAS DETERIORATED BY A MAGNETIC FIELD DISTORTION AND NOT SU

  Patient problems: Bradycardia

  MAUDE report 25824551 ↗
• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: PISCO, J., BILHIM, T., COSTA, N. V., RIBEIRO, M. P., FERNANDES, L., & OLIVEIRA, A. G. (2018). SAFETY AND EFFICACY OF PROSTATIC ARTERY CHEMOEMBOLIZATION FOR PROSTATE CANCER[?]INITIAL EXPERIENCE. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 29(3), 298-305. HTTPS://DOI.ORG/10.1016/J.JVIR.2017.10.013 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES A PATIENT WITH A SMALL AREA OF BLADDER WALL ISCHEMIA THAT WAS REMOVED BY SURGERY IN 1 PATIENT 6 MONTHS AFTER CHEMOEMBOLIZATION. THERE WAS 2 CM2 OF INTRALUMINAL NECROTIC TISSUE ATTACHED TO THE BLADDER WALL BASE, WITHOUT INVOLVEMENT OF THE URETHRA OR URETERS. AMONG THE 4 PATIENTS WITH TECHNICAL FAILURE, 2 PATIENTS UNDERWENT UNILATERAL CHEMOEMBOLIZATION. TWO PATIENTS WITH TECHNICAL FAILURE UNDERWENT RP, 1 OPTED FOR BRACHYTHERAPY, AND THE FOURTH PATIENT REFUSED ANY OTHER TREATMENT. THE TECHNICAL CHANGES WERE FROM " ATHEROSCLEROTIC CHANGES OF BOTH THE ILIAC AND THE PROSTATIC ARTERIES."

  Patient problems: Arteriosclerosis/ Atherosclerosis; Ischemia

  MAUDE report 25813942 ↗
• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: PARIKH, N., KESHISHIAN, E., MANLEY, B., GRASS, G. D., TORRES-ROCA, J., BOULWARE, D., FEUERLEIN, S., POW-SANG, J. M., BAGLA, S., YAMOAH, K., & BHATIA, S. (2021). EFFECTIVENESS AND SAFETY OF PROSTATIC ARTERY EMBOLIZATION FOR THE TREATMENT OF LOWER URINARY TRACT SYMPTOMS FROM BENIGN PROSTATIC HYPERPLASIA IN MEN WITH CONCURRENT LOCALIZED PROSTATE CANCER. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 32(7), 1053-1061. HTTPS://DOI.ORG/10.1016/J.JVIR.2021.03.534 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES AND DESCRIBES 2 PATIENTS EXPERIENCING BLADDER SPASM AND 1 PATIENT EXPERIENCING URINARY RETENTION SUCCESSFULLY TREATED WITH ALPHA-BLOCKERS. ONE CASE RESULTED IN PENILE MEATAL NECROSIS FROM NONTARGET EMBOLIZATION WHICH MET THE CRITERIA FOR SIR GRADE C COMPLICATION. THIS PATIENT WAS SUCCESSFULLY MANAGED WITH SUPPORTIVE CARE AND HEALED 6 WEEKS AFTER PAE. THE PATIENT WAS ALSO ABLE TO SUCCESSFULLY UNDERGO RADIATION THERAPY WITHOUT ACUTE OR CHRONIC GU TOXICITY.

  Patient problems: Bladder Dysfunction; Necrosis; Urinary Retention

  MAUDE report 25813889 ↗
• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: PARIKH, N., KESHISHIAN, E., SHARMA, A., ROCA, M., MANLEY, B., POCH, M., GRASS, G. D., TORRES-ROCA, J., BOULWARE, D., JOHNSTONE, P., MONTEJO, M., SMITH, J., POW-SANG, J., & YAMOAH, K. (2020). PROSTATIC ARTERY EMBOLIZATION IS SAFE AND EFFECTIVE FOR MEDICALLY RECALCITRANT RADIATION-INDUCED PROSTATITIS. ADVANCES IN RADIATION ONCOLOGY, 5(5), 905-909. HTTPS://DOI.ORG/10.1016/J.ADRO.2020.03.015 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES THE MICROSPHERES USED IN PROSTATIC ARTERY EMBOLIZATION (PAE) PROCEDURES HAVE BEEN ASSOCIATED WITH BLADDER SPASMS THAT WERE RELIEVED WITH MEDICATION AND RESOLVED AT 1 WEEK FOR THE 2 (TWO) PATIENTS.

  Patient problems: Bladder Dysfunction

  MAUDE report 25813773 ↗
• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: MALLING, B., RØDER, M. A., LINDH, M., FREVERT, S., BRASSO, K., & LÖNN, L. (2019). PALLIATIVE PROSTATE ARTERY EMBOLIZATION FOR PROSTATE CANCER: A CASE SERIES. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 42(10), 1405-1412. HTTPS://DOI.ORG/10.1007/S00270-019-02227-4 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES THE MICROSPHERES USED IN PALLIATIVE PROSTATE ARTERY EMBOLIZATION (PPAE) PROCEDURES HAVE BEEN ASSOCIATED WITH POST EMBOLIZATION SYNDROME, GROIN HEMATOMA, SELF-LIMITING BALANITIS, UTI, AND PELVIC PAIN. A PATIENT EXPERIENCED A URINARY TRACT INFECTION MANAGED WITH ORAL ANTIBIOTICS FOR 7 DAYS, AND PROLONGED (5 DAYS) PELVIC PAIN TREATED WITH PARACETAMOL MADE UP THE TWO GRADE 3 COMPLICATIONS OBSERVED.

  Patient problems: Pelvic Pain; Urinary Tract Infection

  MAUDE report 25810613 ↗
• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  THE PUBLICATION DESCRIBES MULTIPLE SERIOUS INJURY EVENTS SUMMARIZED IN AGGREGATE FORM WITHOUT COMPLETE PATIENT-LEVEL DETAIL. THEREFORE, THE MANUFACTURER IS SUBMITTING A CONSOLIDATED LITERATURE-BASED MDR REPRESENTING THE SERIOUS INJURY EVENT TYPE DESCRIBED IN THE ARTICLE. STUDY: IMAMURA, A., TAGUCHI, H., TAKANO, H., FUNATSU, H., NAKAMURA, K., ARIMITSU, H., & CHIBA, S. (2021). WHOLE-LIVER TRANSCATHETER ARTERIAL CHEMOINFUSION AND BLAND EMBOLIZATION WITH FINE-POWDER CISPLATIN AND TRISACRYL GELATIN MICROSPHERES FOR TREATING UNRESECTABLE MULTIPLE HEPATOCELLULAR CARCINOMA. JAPANESE JOURNAL OF RADIOLOGY, 39(5), 494-502. HTTPS://DOI.ORG/10.1007/S11604-020-01078-1 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES THAT THE MICROSPHERES USED IN ARTERIAL CHEMOINFUSION AND BLAND EMBOLIZATION (TACBE) PROCEDURES HAVE BEEN ASSOCIATED WITH ANOREXIA, NAUSEA, FATIGUE, FEVER WITHOUT NEUTROPENIA, VOMITING, ABDOMINAL PAIN, VASOVAGAL EPISODE, HYPOTENSION, AND HICCUPS. IT IS UNKNOWN WHICH PATIENTS RECEIVED SPECIFIC EMBOLICS, THUS MAKING IT DIFFICULT TO DETERMINE IF THE MERIT MEDICAL DEVICE WAS ASSOCIATED WITH ANY OF THE DOCUMENTED EVENTS. ANTIEMETIC AGENTS, INCLUDING A 5-HT3

  Patient problems: Abdominal Pain; Fatigue; Fever; Hiccups; Low Blood Pressure/ Hypotension; Syncope/Fainting; Vomiting

  MAUDE report 25810539 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  THE PUBLICATION DESCRIBES MULTIPLE SERIOUS INJURY EVENTS SUMMARIZED IN AGGREGATE FORM WITHOUT COMPLETE PATIENT-LEVEL DETAIL. THEREFORE, THE MANUFACTURER IS SUBMITTING A CONSOLIDATED LITERATURE-BASED MDR REPRESENTING THE SERIOUS INJURY EVENT TYPE DESCRIBED IN THE ARTICLE. STUDY: STUDY: CAPOCASALE, E., LARINI, P., MAZZONI, M. P., MARCATO, C., VALLE, R. D., BUSI, N., MONACO, D., BENOZZI, L., & SIANESI, M. (2005). PERCUTANEOUS RENAL ARTERY EMBOLIZATION OF NONFUNCTIONING ALLOGRAFT: PRELIMINARY EXPERIENCE. TRANSPLANTATION PROCEEDINGS, 37(6), 2523-2524. HTTPS://DOI.ORG/10.1016/J.TRANSPROCEED.2005.06.016 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES THAT THE MICROSPHERES USED IN PERCUTANEOUS RENAL ARTERY EMBOLIZATION (PRAE) PROCEDURES HAVE BEEN ASSOCIATED WITH HEMATURIA, AND SEPTIC FEVER. ECHOCOLOR DOPPLER AND CLINICAL EVALUATION WAS SCHEDULED AT DISCHARGE AND REPEATED AT THE 1, 3, 6, AND 12 MONTHS FOLLOW-UP. IMMEDIATE TECHNICAL SUCCESS WAS ACHIEVED IN ALL CASES; NO COMPLICATIONS OCCURRED. IN 3 CASES, COMPLETE RESOLUTION OF THE SYNDROME WAS OBTAINED. ONE PATIENT WITH PERSISTING HEMATURIA UNDERWENT ANGIOGRAPHY THAT DISCLOSED A PERIRENAL COLLATERAL CIRCULA

  Patient problems: Fever; Hematuria; Implant Pain; Sepsis

  MAUDE report 25803133 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  THE PUBLICATION DESCRIBES MULTIPLE SERIOUS INJURY EVENTS SUMMARIZED IN AGGREGATE FORM WITHOUT COMPLETE PATIENT-LEVEL DETAIL. THEREFORE, THE MANUFACTURER IS SUBMITTING A CONSOLIDATED LITERATURE-BASED MDR REPRESENTING THE SERIOUS INJURY EVENT TYPE DESCRIBED IN THE ARTICLE. STUDY: STUDY: FRANDON, J., BEY, E., HAMARD, A., MOHAMMAD, H., GONZALEZ, S., GREFFIER, J., CHEVALLIER, T., DE FORGES, H., BEREGI, J.-P., & DROUPY, S. (2021). EARLY RESULTS OF UNILATERAL PROSTATIC ARTERY EMBOLIZATION AS A FOCAL THERAPY IN PATIENTS WITH PROSTATE CANCER UNDER ACTIVE SURVEILLANCE: CANCER PROSTATE EMBOLISATION, A PILOT STUDY. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 32(2), 247-255. HTTPS://DOI.ORG/10.1016/J.JVIR.2020.10.002 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES THE MICROSPHERES USED IN PROSTATIC ARTERY EMBOLIZATION (PAE) PROCEDURES THAT HAVE BEEN ASSOCIATED WITH URINARY INFECTION, PAIN, AND ACCESS SITE HEMATOMA. EMBOLIZATION WAS SUCCESSFULLY ACHIEVED IN ALL PATIENTS; PROSTATE ISCHEMIA WAS CONFIRMED ON MULTIPARAMETRIC MR IMAGING, AND NO OFF-TARGET ISCHEMIA WAS REPORTED. NO MAJOR COMPLICATIONS WERE REPORTED. TWO PATIENTS THAT EXPERIENCED ADVERSE EVENTS.

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 25802108 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: CHENG, K.-L., LIANG, K.-W., LEE, H.-L., WANG, H.-Y., & SHEN, C.-Y. (2023). THYROID ARTERY EMBOLIZATION OF LARGE SOLITARY SYMPTOMATIC BENIGN THYROID NODULES THROUGH TRANSRADIAL APPROACH. QUANTITATIVE IMAGING IN MEDICINE AND SURGERY, 13(8), 5355-5361. HTTPS://DOI.ORG/10.21037/QIMS-22-1385 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES THE EFFICACY AND SAFETY OF TRANSRADIAL ACCESS (TRA) THYROID ARTERY EMBOLIZATION (TAE) FOR PATIENTS WITH LARGE SOLITARY SYMPTOMATIC BENIGN THYROID NODULES. THIS LITERATURE ARTICLE DESCRIBES MULTIPLE PATIENT EVENTS. THE STUDY ALLEGES THE MICROSPHERES USED IN THYROID ARTERY EMBOLIZATION (TAE) PROCEDURES HAVE BEEN ASSOCIATED WITH RADIAL ARTERY SPASM, PAIN, VOMITING, VOICE CHANGE, AND NECK PAIN. 30 F RADIAL ARTERY SPASM, PAIN. INTRAPROCEDURAL COMPLICATION WITH RADIAL ARTERY SPASM WAS OBSERVED DURING CATHETERIZATION, WHICH RESOLVED WITH ADMINISTRATION OF INTRA-ARTERIAL CALCIUM CHANNEL BLOCKER. 42 M RECEIVED OMA FOR NECK PAIN RESOLVED AFTER ORAL MEFENAMIC ACID TREATMENT. NO OVERT OR SUBCLINICAL HYPERTHYROIDISM AND NO MAJOR COMPLICATIONS WERE NOTED. 23 M NECK PAIN AND STEROIDS FOR HOARSENESS OCCURRED WITHIN 1 WEEK AFTER

  Patient problems: Dyskinesia; Neck Pain; Voice alteration; Vomiting

  MAUDE report 25798652 ↗
• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: SHIMOHIRA, M., NAGAI, K., OHTA, K., SAWADA, Y., NAIKI, T., NAGAI, T., YASUI, T., & SHIBAMOTO, Y. (2021). USE OF MICROSPHERES IN EMBOLIZATION FOR UNRUPTURED RENAL ANGIOMYOLIPOMAS. OPEN MEDICINE, 16(1), 655-659. HTTPS://DOI.ORG/10.1515/MED-2021-0280 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES THE USE OF MICROSPHERES IN EMBOLIZATION FOR UNRUPTURED RENAL ANGIOMYOLIPOMAS WAS REVIEWED AND ALLEGES THE MICROSPHERES FOR UNRUPTURED RENAL ANGIOMYOLIPOMAS HAVE BEEN ASSOCIATED WITH PAIN AND FOCAL RENAL INFARCTION. THREE PATIENTS EXHIBITED SLIGHT PAIN, TWO FEMALES, AGED 56 AND 39, AND ONE MALE, AGED 45, BUT IT IMPROVED WITH ONLY OBSERVATION. IN NO PATIENT, EXTENDED HOSPITALIZATION OR AN ADVANCED LEVEL OF CARE WAS NECESSARY, AND NO PERMANENT ADVERSE SEQUELAE OR DEATH OCCURRED.

  Patient problems: Kidney injury; Necrosis; Pain

  MAUDE report 25748728 ↗
• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: SAPOVAL, M., THIOUNN, N., DESCAZEAUD, A., DÉAN, C., RUFFION, A., PAGNOUX, G., DUARTE, R. C., ROBERT, G., PETITPIERRE, F., KARSENTY, G., VIDAL, V., MUREZ, T., VERNHET-KOVACSIK, H., DE LA TAILLE, A., KOBEITER, H., MATHIEU, R., HEAUTOT, J.-F., DROUPY, S., FRANDON, J., VAPPEREAU, A. (2023). PROSTATIC ARTERY EMBOLISATION VERSUS MEDICAL TREATMENT IN PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA (PARTEM): A RANDOMISED, MULTICENTRE, OPEN-LABEL, PHASE 3, SUPERIORITY TRIAL. THE LANCET REGIONAL HEALTH - EUROPE, 31, 100672. HTTPS://DOI.ORG/10.1016/J.LANEPE.2023.100672 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES THAT AT THE 9 MONTHS FOLLOW-UP, THERE WERE A TOTAL OF 31 PATIENTS IN THE PAE GROUP AND 21 PATIENTS IN THE CT GROUP PRESENTED AT LEAST ONE SERIOUS INJURY (TABLE 3). NO HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION INDUCED BY A SERIOUS INJURY RELATED TO THE TREATMENT WAS OBSERVED. SEE TABLE 3 ON PAGE 9 OF THE ATTACHED ARTICLE FOR ALL SIDE EFFECTS OF THE PROCEDURE. THE PUBLICATION DESCRIBES MULTIPLE SERIOUS INJURY EVENTS SUMMARIZED IN AGGREGATE FORM WITHOUT COMPLETE PATIENT-LEVEL DETAIL. THEREFORE, THE MANUFACTURER IS SUBMITTING A CONSOLIDATED

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arrhythmia; Cancer; Dizziness; Dyspnea; Dysuria; Hematoma; Hyperplasia; Limb Pain; Localized Skin Lesion; Loss of Range of Motion; Low Blood Pressure/ Hypotension; Myalgia; Pain; Pelvic Pain; Perforation of Vessels; Reaction to Medicinal Component of Device; Renal Impairment; Rhinitis; Skin Infection; Swelling/ Edema; Transient Ischemic Attack; Unintended Radiation Exposure; Unspecified Kidney or Urinary Problem; Unspecified Skin and Subcutaneous Tissue Problem; Urinary Frequency / Polyuria; Urinary Retention; Urinary Tract Infection; Vascular Dissection

  MAUDE report 25745643 ↗
• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: CAPPELLI, A., MOSCONI, C., COCOZZA, M. A., BRANDI, N., BARTALENA, L., MODESTINO, F., GALAVERNI, M. C., VARA, G., PACCAPELO, A., PIZZOLI, G., VILLA, G., SERACCHIOLI, R., & RENZULLI, M. (2023). UTERINE ARTERY EMBOLIZATION FOR THE TREATMENT OF SYMPTOMATIC UTERINE FIBROIDS OF DIFFERENT SIZES: A SINGLE CENTER EXPERIENCE. JOURNAL OF PERSONALIZED MEDICINE, 13(6), 906. HTTPS://DOI.ORG/10.3390/JPM13060906. THE STUDY ALLEGES THE EMBOSPHERE MICROSPHERES USED IN UTERINE ARTERY EMBOLIZATION (UAE) PROCEDURES HAVE BEEN ASSOCIATED WITH MILD POSTOPERATIVE PAIN AND HYPERPYREXIA. "FOLLOWING THE PROCEDURE, ALMOST ALL OF THE PATIENTS (96.8%, 61/63) MANIFESTED MILD PAIN, WHICH WAS PROMPTLY CONTROLLED WITH NSAIDS OR MINOR OPIOIDS, LEAVING JUST A SLIGHT ABDOMINAL DISCOMFORT LASTING < 7 DAYS. NO PATIENTS SHOWED MAJOR COMPLICATIONS RELATED TO THE PROCEDURE, AND ONLY 2 (3.2%) OF THEM HAD HYPERPYREXIA (T> 38C) DURING THE HOSPITAL STAY, WHICH WAS TREATED WITH THE ADMINISTRATION OF ANTIPYRETICS." "12 PATIENTS HAD PERSISTENCE OF SYMPTOMS AFTER THE UAE AND 4 SUBSEQUENTLY UNDERWENT HYSTERECTOMIES LATER DUE TO INADEQUATE SYMPTOM CONTROL."

  Patient problems: Discomfort; Fever; Pain

  MAUDE report 25745582 ↗
• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  STUDY: BAI, J., SONG, J., ZHANG, Y., LI, X., YAN, L., HU, P., & TANG, Q. (2023). TRANSCATHETER ARTERIAL EMBOLIZATION IN PATIENTS WITH NEUROENDOCRINE NEOPLASMS RELATED TO LIVER METASTASIS WITH DIFFERENT BLOOD SUPPLIES. CANCER MEDICINE, 12(18), 18578-18587. HTTPS://DOI.ORG/10.1002/CAM4.6464 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES THE MICROSPHERES USED IN TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) PROCEDURES HAVE BEEN ASSOCIATED WITH ABDOMINAL PAIN, ALANINE AMINOTRANSFERASE ELEVATION (LIVER DAMAGE), VOMITING, FEVER, AND THROMBOCYTOPENIA. ONE PATIENT DEVELOPED A LIVER ABSCESS THAT PROLONGED THE HOSPITALIZATION PERIOD. ALL PATIENTS WITH ADVERSE EVENTS IMPROVED AND WERE DISCHARGED AFTER SYMPTOMATIC TREATMENT.

  Patient problems: Abdominal Pain; Abscess; Fever; Liver Damage/Dysfunction; Thrombocytopenia; Vomiting

  MAUDE report 25745478 ↗
• InjuryJun 16, 2026Patient Device Interaction Problem

  CASE REPORT: MRI DETECTION OF UTERINE NECROSIS AFTER UTERINE ARTERY EMBOLIZATION FOR FIBROIDS REPORTED THAT TWO HOURS AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF A SMALL AMOUNT OF VAGINAL BLEEDING AND TYPICAL POSTEMBOLIZATION PAIN THAT WAS CONTROLLED WITH NARCOTIC MEDICATION. SHE HAD PERSISTENT COMPLAINTS OF PELVIC PAIN, AND AN MRI WAS PERFORMED AFTER THE PROCEDURE. AFTER MRI, HER PAIN WAS CONTROLLED WITH ORAL MEDICATION, AND SHE WAS DISCHARGED THE FOLLOWING DAY WITH NO INTRAPROCEDURAL COMPLICATIONS BEING NOTED. FOUR DAYS AFTER UTERINE ARTERY EMBOLIZATION, THE PATIENT RETURNED TO HER GYNECOLOGIST FOR EVALUATION. SHE REPORTED SEVERE PAIN. THE PATIENT WAS AFEBRILE WITH STABLE VITAL SIGNS. BECAUSE OF THE MRI FINDINGS SUGGESTING MINIMAL UTERINE PERFUSION, ALONG WITH THE CLINICAL SYMPTOMS, A TOTAL ABDOMINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY WERE PERFORMED 4 DAYS AFTER UTERINE ARTERY EMBOLIZATION. THE PATIENT TOLERATED THIS PROCEDURE WELL AND WAS DISCHARGED ON DAY 3 AFTER THE OPERATION. ON GROSS INSPECTION, THE BIVALVED UTERUS WAS THE SIZE OF A UTERUS IN THE 14TH WEEK OF PREGNANCY AND HAD A MYOMETRIAL WALL THICKNESS OF 5.5 CM. IT CONTAINED A 5.5 × 5.5 × 4 CM SUBMUCOSAL

  Patient problems: Necrosis

  MAUDE report 25521684 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE REPORTED GI BLEEDING AS A SIGNIFICANT COMPLICATION, REQUIRING CLINICAL MANAGEMENT AND ADDITIONAL INTERVENTION. NO DEVICE MALFUNCTION IDENTIFIED.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 23854840 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE REPORTED SPLENIC ABSCESS OCCURRED FOLLOWING PSE. PATIENTS DEVELOPED INFECTIOUS COMPLICATIONS IN THE INFARCTED SPLENIC TISSUE, AND ABSCESS FORMATION REQUIRED FURTHER MEDICAL AND/OR INTERVENTIONAL MANAGEMENT. NO DEVICE MALFUNCTION IDENTIFIED.

  Patient problems: Abscess; Tissue Breakdown

  MAUDE report 23854822 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE REPORTED A THROMBOTIC EVENT THAT OCCURRED IN THE PORTAL VENOUS SYSTEM FOLLOWING PSE AND REQUIRED FURTHER EVALUATION AND MANAGEMENT. NO DEVICE MALFUNCTION IDENTIFIED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23851881 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE REPORTED THROMBOSIS OF THE SPLENIC VEIN AFTER EMBOLIZATION, REQUIRING CLINICAL MANAGEMENT NO DEVICE MALFUNCTION IDENTIFIED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23851880 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE REPORTED A CTCAE GRADE 3 PULMONARY EMBOLISM OCCURRED AFTER THE PROCEDURE. THE PULMONARY EMBOLISM REQUIRED MEDICAL MANAGEMENT. NO DEVICE MALFUNCTION IDENTIFIED.

  Patient problems: Pulmonary Embolism

  MAUDE report 23851856 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE REPORTED POST-EMBOLIZATION SYNDROME, ACUTE TUBULAR NECROSIS, PROSTATITIS, AND URINARY TRACT INFECTION POST EMBOLIZATION USE. NO DEVICE MALFUNCTION IDENTIFIED.

  Patient problems: Inflammation; Necrosis; Urinary Tract Infection

  MAUDE report 23851855 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181300. One submission often covers many models, so check the product and lot details in each record.

• Z-3305-2026 · Aug 10, 2026 · Open, Classified
  Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB; Embosphere 900-