LAVA-34, 6 mL SLLES346Recalls & reported problems
Sirtex Medical Inc. · LAVA Liquid Embolic System (LES) Kit, LAVA-34, 6 mL · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850055697034), received between Mar 30, 2026 and Aug 7, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (2 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.
Reports received per month
Most reported problems
Device problems
- Product Quality Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50178262 ↗MalfunctionMar 30, 2026Product Quality Problem
THE PHYSICIAN WAS PERFORMING AN EVAR TYPE 2 ENDOLEAK PROCEDURE AND STATED THE LAVA 34 DID NOT HAVE ITS USUAL OPACITY AND WAS VERY HARD TO SEE. THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715188 ↗
Other Embolization Agent, Vascular devices
- LAVA-18, 2 mL SLLES182Sirtex Medical Inc. · Embolization Agent, Vascular14 reports
- LAVA-18, 6 mL SLLES186Sirtex Medical Inc. · Embolization Agent, Vascular7 reports
- LAVA-34, 2 mL SLLES342Sirtex Medical Inc. · Embolization Agent, Vascular4 reports
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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