LAVA-34, 2 mL SLLES342Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850055697010), received between Apr 7, 2025 and Apr 7, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Transmit Record” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Product Quality Problem

  THE VORTEX MIXER AND ATTACHMENT USED IN THIS EVENT DID NOT SECURELY HOLD THE VIAL OF LAVA CAUSING IT TO COME OFF THE MIXER AND BREAK. PROPER MIXING OF THE LAVA DEVICE IS INTEGRAL FOR ITS INTENDED USE. SIRTEX MEDICAL, INC. IS NOT THE MANUFACTURER OF THE VORTEX MIXER OR THE ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802619 ↗
• MalfunctionJul 30, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6), I ATTENDED A POTENTIAL LAVA CASE. THE PHYSICIAN STATED THEY USED LAVA-34 2ML THE WEEK PRIOR AND THE LAVA DID NOT FUNCTION AS THEY HAD HOPED. THERE WAS A LOT OF PRESSURE AND THE LAVA ACTUALLY CAME BACKWARDS OUT OF THE MICRO AND FLEW AGAINST THE WALL DURING THE CASE. WE DISCUSSED THIS AND THOUGHT IT SEEMED STRANGE. DURING THE CASE ON (B)(6), I BEGAN TO SHAKE 2 6ML VIALS OF LAVA, ONE WAS 18 AND ONE WAS 34, IN CASE THE PHYSICIAN DID DECIDE TO USE THE PRODUCT. I SHOOK FOR AT LEAST 2 CYCLES OF 20 MINUTES AND NOTICED THAT THE VIALS LOOKED VERY DIFFERENT. ONE LOOKED WELL MIXED, AND THE OTHER WAS VERY THIN AND JUST HAD CLUMPS OF THE PRODUCT STICKING TO THE TOP AND BOTTOM OF THE VIAL. I THEN LOOKED AT ALL THE VIALS ON THE SHELF AND NOTICED IT SEEMED TO BE HAPPENING WITH ANOTHER 6 ML VIAL AND POTENTIALLY 2, 2 ML VIALS. ANOTHER STRANGE THING I NOTICED WAS THAT THESE PARTICULAR VIALS HAD A DOT MARKED ON THE TOP OF THE SECURE LID WITH BLACK SHARPIE, ALMOST AS IF THEY WERE MARKED AS SOMETHING WAS WRONG. I THEN BEGAN TO WONDER IF THIS COULD HAVE BEEN THE REASON FOR SOMETHING GOING WRONG IN THE PREVIOUS CASE. DURING THE CASE ON (B)(6), THE PHYSICIAN ACTUALLY DID NOT NEED TO USE LAVA SO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668151 ↗
• MalfunctionJul 30, 2025Failure to Transmit Record; Failure to Transmit Record

  LAVA WAS NOT VISIBLE UNDER FLUORO. VIAL WAS ON THE VORTEX FOR 8 MINS THEN HAND MIXED WITH THE MIXING KIT FOR 30 PASSES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22668028 ↗
• InjuryApr 7, 2025Unintended Movement; Unintended Movement

  TWO ISSUES OBSERVED DURING THE CASE: 1. UPON ADMINISTRATION OF DMSO (0.5 ML, IN ACCORDANCE WITH DEAD SPACE OF CATHETER)), PATIENT EXPERIENCED SIGNIFICANT PAIN, BEGAN THRASHING UNCONTROLLABLY ON TABLE, AND BLOOD PRESSURE INCREASED SIGNIFICANTLY. IT TOOK MORE THAN 60 MINUTES POST PROCEDURE FOR ANESTHESIA TO ONCE AGAIN STABILIZE PATIENT AND GET BACK TO NORMAL. 2. DURING THE EMBOLIZATION OF THE GDA, PHYSICIAN PLACED ONE COIL DISTALLY AFTER MEASURING THE VESSEL AT 3.5 MM. INITIALLY, A 4MM COIL WAS USED WHICH FAILED TO DEPLOY, SO PHYSICIAN CHANGED TO A 3 MM COIL. THIS COIL DEPLOYED ABOUT 75% AND THE REMAINING TAIL WAS PROXIMAL TOWARDS THE MICROCATHETER TIP WHERE LAVA WOULD BE DEPLOYED TO FILL SPACE. AS PHYSICIAN BEGAN ADVANCING LAVA AT 0.3 ML/MIN RATE, THE LAVA BECAME VISIBLE IN GDA AND BEGAN TO FILL SPACE BETWEEN COIL AND CATHETER. THEN LAVA WAS VISUALIZED IN COLLATERAL VESSELS NOT ADJACENT TO THE GDA (NON-TARGET AREAS). PHYSICIAN STOPPED DELIVERING LAVA AT THIS POINT AND PLACED 2 COILS PROXIMALLY TO END CASE. ANESTHESIA WAS CALLED TO HELP GET PATIENT BLOOD PRESSURE AND STABILIZE, WHICH TOOK 60+ MINUTES AFTER PROCEDURE.

  Patient problems: High Blood Pressure/ Hypertension; Pain

  MAUDE report 21792644 ↗