LC Bead 100-300 VE220GSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060116920185), received between Nov 5, 2018 and Sep 6, 2019 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathSep 6, 2019Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  INFORMATION FROM LITERATURE ARTICLE REVIEW: PROSPECTIVE PHASE II TRIAL OF DRUG-ELUTING BEAD CHEMOEMBOLIZATION FOR LIVER TRANSPLANT CANDIDATES WITH HEPATOCELLULAR CARCINOMA AND MARGINAL HEPATIC RESERVE - NICHOLAS FIDELMAN ET AL. DEB-TACE WAS PERFORMED WITH UP TO TWO 2-ML VIALS OF SPHERICAL POLYVINYL ALCOHOL MICROSPHERES (LC BEAD® 100 - 300 MICRONS); IMPREGNATED PER STANDARD MANUFACTURER SUPPLIED PROTOCOL WITH A TOTAL OF 100 MG OF RECONSTITUTED DOXORUBICIN HYDROCHLORIDE POWDER (25 MG PER MILLILITRE OF BEADS). A TOTAL OF 17 PATIENTS (MEDIAN AGE 66 YEARS, RANGE 58-73 YEARS; 13 MEN) WERE TREATED WITH AT LEAST 1 DEB-TACE PROCEDURE DURING THE FIRST STAGE OF THE STUDY. HEPATITIS C VIRUS INFECTION WAS THE MOST COMMON CAUSE FOR CIRRHOSIS (8 PATIENTS, 47%). THE MAJORITY OF THE PATIENTS QUALIFIED FOR INCLUSION BASED ON PRESENCE OF SYMPTOMATIC ASCITES (14 PATIENTS, 82%), SERUM BILIRUBIN BETWEEN 3 AND 6 MG/DL (5 PATIENTS, 29%), AND/OR COAGULOPATHY (4 PATIENTS, 24%). THREE PATIENTS QUALIFIED FOR INCLUSION BASED ON PRESENCE OF MAIN PORTAL VEIN THROMBOSIS, PATENT TRANS-JUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS), OR A PATENT SURGICAL SHUNT. MEDIAN CTP SCORE WAS 10 (RANGE 6-12), AND MEDIAN MELD

  Patient problems: Anemia; Ascites; Constipation; Death; Diarrhea; Dyspnea; Edema; Fatigue; Fever; Hiccups; Hyperbilirubinemia; Liver Damage/Dysfunction; Nausea; Pain; Sleep Dysfunction; Test Result; Vomiting; Weight Changes

  MAUDE report 8969566 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PART BTG'S POST MARKET SURVEILLANCE ACTIVITIES A REVIEW OF LITERATURE ARTICLE "SINGLE-CENTRE PASE II TRIAL OF TRANSARTERIAL CHEMOEMBOLIZATION WITH DRUG-ELUTING BEADS FOR PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA" AUTHOR DIANE K REYES ET AL WAS PERFORMED. THIS IS THE PUBLISHED PAPER FROM STUDY (B)(6). TWENTY PATIENTS WITH UNRESECTABLE HCC WERE TREATED WITH LC BEADS, POLYVINYL ALCOHOL MICROSPHERES WITH DIAMETERS OF 100-300UM OR 300-500UM, WHICH ARE LOADED WITH 100MG OF DOXORUBICIN HYDROCHLORIDE AND MIXED WITH AN EQUAL VOLUME OF NONIONIC CONTRAST MEDIA. THEY WERE ASSESSED AT 1 MONTH AND 3 MONTH FOLLOW-UPS. THE PAPER DESCRIBED "AN" SERIOUS ADVERSE EVENT IN 1 PATIENT WITH POST-TACE SYNDROME WHICH REQUIRED SUPPORTIVE CARE, TWO PATIENTS WHO DIED (NOT DEVICE RELATED), AND NON-SERIOUS ADVERSE EVENTS IN 19 PATIENTS. SERIOUS ADVERSE EVENTS - RELATED: A POST-TACE SYNDROME WAS OBSERVED ONLY IN 1 PATIENT THAT REQUIRED SUPPORTIVE CARE. SERIOUS ADVERSE EVENTS - NOT RELATED: 1 PATIENT DIED OF MULTIORGAN FAILURE. THE PATIENT EXPERIENCED "DIARRHEAD" AND "DEYDRATION" AFTER DEB-TACE2, WAS TREATED AT AN OUTSIDE FACILITY WITH "DIURECTIS" FOR PERSISTENT EDEMA, BUT REMAINED "HYPOVOLEMC" AND "H

  Patient problems: Abdominal Pain; Anemia; Diarrhea; Fatigue; Fever; Gastritis; Hair Loss; Liver Damage/Dysfunction; Nausea; No Code Available; Test Result; Vomiting; Weight Changes

  MAUDE report 8037192 ↗