LAVA-18, 6 mL SLLES186Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850055697027), received between Feb 27, 2024 and May 4, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Transmit Record” (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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Product Quality Problem

  THE COMPLAINT STATED THE SYRINGE PLUNGER COMES ALL THE WAY OUT OF THE SYRINGE AND HAS CAUSED LAVA TO SPILL OUT MULTIPLE TIMES. THERE WAS NO PATIENT HARM AND PROCEDURE WAS COMPLETED. IT WAS SUGGESTED TO HAVE BETTER SYRINGES AND TO HAVE DIFFERENT COLOR LABELS FOR LAVA-18 AND LAVA-34 AS CURRENTLY BOTH ARE ORANGE AND ARE HARD TO DIFFERENTIATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074213 ↗
• MalfunctionMay 4, 2026Product Quality Problem

  THE PHYSICIAN STATED THEY HAD DIFFICULTY SEEING THE LAVA DURING ADMINISTRATION BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073699 ↗
• InjuryMay 4, 2026Material Puncture/Hole; Pressure Problem; Poor Visibility

  A PHYSICIAN EXPERIENCED PRESSURE IN THE SYRINGE WHILE DELIVERING LAVA-18 FOR A T2 ENDOLEAK USING A TERUMO PROGREAT LAMBDA CATHETER (175CM). THE PHYSICIAN STATED THE PRESSURE WAS NOT ALLOWING THEM TO DELIVER THE LAVA BUT CONTINUED WITH THE PROCEDURE WHEN THE PRESSURE RESOLVED. UPON VIEWING THE ANGIO SCREEN, THE LAVA WAS SEEN LOWER/INFERIOR TO WHERE THE CATHETER TIP WAS LOCATED NEAR THE ENDOLEAK. THE DECISION WAS MADE TO STOP ADMINISTRATION, AND TO REMOVE THE CATHETER. A HOLE ON THE CATHETER WAS DISCOVERED. IT WAS UNKNOWN IF THE HOLE WAS PRESENT BEFORE THE PROCEDURE. THE PHYSICIAN PERFORMED A PERCUTANEOUS STICK USING LAVA-18 WHICH SUCCESSFULLY TREATED THE ENDOLEAK. IT WAS STATED THAT THERE WAS A POTENTIAL FOR ISCHEMIA IN THE BOWEL AND THE PATIENT WAS BEING MONITORED.

  Patient problems: Hematoma

  MAUDE report 25073322 ↗
• InjuryJul 30, 2025Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  DURING EMBOLIZATION PROCEDURE, LAVA 18 APPEARED IN THE IMA AFTER THE ENDOLEAK WAS FILLED. PATIENT ADMITTED FOR RISK OF SMALL BOWEL ISCHEMIA. THE PATIENT WAS ADMITTED FOR OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669055 ↗
• MalfunctionJul 30, 2025Failure to Transmit Record; Failure to Transmit Record

  HOSPITAL STAFF FOLLOWED DIRECTIONS BY SHAKING LAVA FOR OVER 20 MINS. THE TECH PULLED UP 2 ONE ML SYRINGES OF LAVA. THE PHYSICIAN SLOWLY INJECTED DMSO THROUGH A NEEDLE, AS HE WAS PERFORMING AN ENDOLEAK PROCEDURE. THE PHYSICIAN THEN INJECTED ONE SYRINGE OF LAVA AND COULD NOT VISUALIZE THE LAVA UNDER FLUOROSCOPY. HE THEN REACHED FOR A SECOND SYRINGE AND SLOWLY INJECTED THE LAVA. HE STOPPED AT ABOUT 0.5 ML SINCE AGAIN HE STILL COULD NOT VISUALIZE THE LAVA. HE FINISHED THE PROCEDURE BY USING A NON SIRTEX/BLACKSWAN PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668020 ↗
• MalfunctionJul 30, 2025Failure to Transmit Record; Failure to Transmit Record

  WHILE INJECTING FIRST TWO SYRINGES OF LAVA, IT WAS NOT SEEN ON FLUORO. THE PHYSICIAN PUT THE SYRINGES UNDER FLUORO AND THEY WERE NOT RADIOPAQUE. ANOTHER VIAL WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667976 ↗
• MalfunctionFeb 27, 2024Infusion or Flow Problem; Infusion or Flow Problem

  PHYSICIAN WAS USING A 6 ML LAVA VIAL FOR AN OFF LABEL USE AND COULD ONLY GET 5.0 ML OUT OF THE VIAL. DIFFERENT ANGLES AND NEEDLES WERE TRIED TO GET THE LAVA OUT, BUT PHYSICIAN COULD NOT GET ANY MORE PRODUCT OUT OF THE VIAL. PHYSICIAN COMPLETED PROCEDURE BY USING COILS SINCE NO ADDITIONAL LAVA PRODUCT WAS AVAILABLE ON SITE. PATIENT WAS NOT AFFECTED. THE REPORT STATES, "PATIENT DID FINE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793552 ↗