LC Bead LUMI 40 - 90 RO2L000Recalls & reported problems
Boston Scientific Corporation · Embolic spheres · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060116921229), received between Dec 20, 2018 and Dec 20, 2018 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Vomiting1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT (B)(6) FROM (B)(6) TRIAL (B)(6) EXPERIENCED: HEMATEMESIS (B)(6) 2017 TO (B)(6) 2017. INVESTIGATOR REPORTED: EVENT OCCURRED AFTER M0 TREATMENT AND PATIENT HAD ADVANCED LIVER DISEASE WITH NUMEROUS PREVIOUS LOCOREGIONAL THERAPIES (Y90, TACE X 2, PERCUTANEOUS ETHANOL ABLATION, RFA). PATIENT ALSO HAD M1 TREATMENT MONTHS BEFORE ON (B)(6) 2017 AND FOLLOWED BY PERCUTANEOUS ETHANOL ABLATION. THE M0 TREATMENT (BEADS LOADED WITH DOXORUBICIN WITH 30 MIN ABSORBING TIME) WAS (B)(6) 2017 AND DATE OF EVENT WAS (B)(6) 2017 WHERE THE PATIENT RECEIVED VARICEAL BANDING ((B)(6) 2017) AND SUBSEQUENT EMBOLIZATION ((B)(6) 2017) AND WAS ULTIMATELY TRANSPLANTED (B)(6) 2018. NO FOLLOW UP AFTER TRANSPLANT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Vomiting
MAUDE report 8184355 ↗
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- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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