LC Bead LUMI 70 - 150 RO2L001Recalls & reported problems
Boston Scientific Corporation · Embolic spheres · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05060116921151), received between Nov 3, 2021 and Nov 3, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (4 reports).
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
- Device Contaminated During Manufacture or Shipping4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT CONTAMINATE WAS FOUND IN THE VIAL. CONTAMINATE WAS FOUND IN THE VIAL PRIOR TO LOADING THE RADIOPAQUE EMBOLIC BEAD 70-150 MIC WITH CHEMOTHERAPY AGENT. THE VIAL/BEADS WERE NOT USED IN A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12746760 ↗MalfunctionNov 3, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT CONTAMINATE WAS FOUND IN THE VIAL CONTAMINATE WAS FOUND IN THE VIAL PRIOR TO LOADING THE RADIOPAQUE EMBOLIC BEAD 70-150 MIC WITH CHEMOTHERAPY AGENT. THE VIAL/BEADS WERE NOT USED IN A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12746756 ↗MalfunctionNov 3, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT CONTAMINATE WAS FOUND IN THE VIAL. CONTAMINATE WAS FOUND IN THE VIAL PRIOR TO LOADING THE RADIOPAQUE EMBOLIC BEAD 70-150 MIC WITH CHEMOTHERAPY AGENT. THE VIAL/BEADS WERE NOT USED IN A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12746754 ↗MalfunctionNov 3, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT CONTAMINATE WAS FOUND IN THE VIAL. CONTAMINATE WAS FOUND IN THE VIAL PRIOR TO LOADING THE RADIOPAQUE EMBOLIC BEAD 70-150 MIC WITH CHEMOTHERAPY AGENT. THE VIAL/BEADS WERE NOT USED IN A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12746583 ↗
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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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