EmbosphereRecalls & reported problems across all models

We found 18 models of Embosphere by Biosphere Medical in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2020 and Jul 16, 2026 — classified as 3 deaths, 40 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (21 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Embosphere recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 10, 2026Open, Classified

   Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.

   Z-3305-2026 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

Most reported Embosphere problems

Embosphere models

18 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Embosphere® 00884450116715

  AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
  1 recall8 reports
• Embosphere® 00884450403136

  Device, Vascular, for Promoting Embolization
  1 recall1 report
• Embosphere® 00884450109519

  AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
  1 recall0 reports
• Embosphere® 00884450402948

  Device, Vascular, for Promoting Embolization
  1 death32 reports
• Embosphere® 00884450403440

  Device, Vascular, for Promoting Embolization
  1 death13 reports
• Embosphere® 00884450098424

  AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
  8 reports
• Embosphere® 00884450098561

  AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
  8 reports
• Embosphere® 00884450403464

  Device, Vascular, for Promoting Embolization
  1 death6 reports
• Embosphere® 00884450403204

  Device, Vascular, for Promoting Embolization
  5 reports
• Embosphere® 00884450403426

  Device, Vascular, for Promoting Embolization
  4 reports
• Embosphere® 00884450106051

  AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
  3 reports
• Embosphere® 00884450403174

  Device, Vascular, for Promoting Embolization
  3 reports
• Embosphere® 00884450104750

  AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
  1 report
• Embosphere® 00884450110621

  AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
  1 report
• Embosphere® 00884450114223

  AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
  1 report
• Embosphere® 00884450116296

  AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
  1 report
• Embosphere® 00884450403150

  Device, Vascular, for Promoting Embolization
  1 report
• Embosphere® 00884450403402

  Device, Vascular, for Promoting Embolization
  1 report

Recent Embosphere adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Fluid/Blood Leak; Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25841917 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  LITTLE, M. W., O'GRADY, A., BRIGGS, J., GIBSON, M., SPEIRS, A., AL-REKABI, A., YOONG, P., ARIYANAYAGAM, T., DAVIES, N., TAYTON, E., TAVARES, S., MACGILL, S., MCLAREN, C., & HARRISON, R. (2024). GENICULAR ARTERY EMBOLISATION IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE (GENESIS) USING PERMANENT MICROSPHERES: LONG-TERM RESULTS. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 47(12), 1750-1762. HTTPS://DOI.ORG/10.1007/S00270-024-03752-7 WAS REVIEWED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. THE PUBLICATION DESCRIBES ONE PATIENT UNDERGOING GAE THAT DEVELOPED A POPLITEAL DEEP VEIN THROMBOSIS (DVT) 15-DAYS POST-INTERVENTION. THE VENOUS THROMBUS WAS NOT DIRECTLY RELATED TO GAE. MOREOVER, IT WAS RELATED TO IMMOBILITY IN THE POST-OPERATIVE PERIOD. THIS COMPLICATION HIGHLIGHTS THE IMPORTANCE OF EARLY MOBILIZATION POST GAE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25829662 ↗
• 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 ↗
• MalfunctionJul 14, 2026Fluid/Blood Leak

  CUSTOMER REPORTED THAT THERE WAS NO LIQUID IN THE SYRINGE IN THE ORIGINAL PACKAGING. THE MICROSPHERE WAS FOUND TO BE IN A DRY STATE, AND THE LIQUID LEAK WAS OBSERVED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812269 ↗
• 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 ↗