LAVA-18, 2 mL SLLES182Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00850055697003), received between May 7, 2024 and Jun 17, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Component Missing

  WHILE PREPARING FOR A PROCEDURE, THE SITE FOUND THE LAVA-34, 2 ML PACKAGE ONLY CONTAINED SYRINGES AND WAS MISSING THE LAVA AND THE DMSO. THE SITE STATED IT WAS NOT USED FOR ANY PRIOR CASES NOR WAS IT SCANNED INTO THEIR SYSTEM FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25533461 ↗
• MalfunctionJun 4, 2026Product Quality Problem; Improper or Incorrect Procedure or Method

  LAVA WORKED BUT THE PHYSICIAN EXPERIENCED DIFFICULTY IN VISUALIZING THE LAVA UNDER THE FLUOROSCOPE. THEY STATED IT WAS LESS OPAQUE THAN OTHER EMBOLIC PRODUCTS THEY HAVE PREVIOUSLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394335 ↗
• MalfunctionMar 10, 2026Product Quality Problem; Improper or Incorrect Procedure or Method

  A PHYSICIAN REPORTED DIFFICULTY VISUALIZING LAVA DURING DELIVERY WHILE PERFORMING A GASTRODUODENAL ARTERY (GDA) EMBOLIZATION. THE PHYSICIAN STATED THAT THE EMBOLIC AGENT WAS VERY DIFFICULT TO SEE UNDER FLUOROSCOPY DURING INJECTION, WHICH MADE HIM HESITANT AND UNCOMFORTABLE DURING DELIVERY. THE PHYSICIAN EXPRESSED CONCERN THAT LIMITED VISUALIZATION INCREASED PROCEDURAL UNCERTAINTY DURING EMBOLIZATION. NO DEVICE MALFUNCTION OR USER ERROR WAS IDENTIFIED OR REPORTED AT THE TIME OF THE PROCEDURE. THE PHYSICIAN SUGGESTED EVALUATING INCREASED RADIOPAQUE CONTENT (E.G., HIGHER TANTALUM CONCENTRATION) OR THE POTENTIAL AVAILABILITY OF AN OPTIONAL KIT THAT WOULD ALLOW ADDITIONAL TANTALUM POWDER TO BE ADDED TO LAVA TO IMPROVE VISUALIZATION DURING DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561487 ↗
• MalfunctionMar 10, 2026Product Quality Problem

  DURING A PERIPHERAL EMBOLIZATION PROCEDURE, THE PHYSICIAN AND IR STAFF WERE UNABLE TO FULLY EXTRACT THE LABELED 2.0 ML VOLUME FROM A LAVA 2 ML VIAL. DESPITE FOLLOWING STANDARD PREPARATION STEPS AND EMPLOYING COMMONLY USED TECHNIQUES TO MAXIMIZE VIAL EXTRACTION, ONLY APPROXIMATELY 1.5 ML OF PRODUCT COULD BE WITHDRAWN. THE PHYSICIAN REQUIRED THE FULL 2.0 ML TO COMPLETE THE PLANNED EMBOLIZATION. DUE TO THE INSUFFICIENT RETRIEVABLE VOLUME, THE PHYSICIAN WAS REQUIRED TO TRANSITION TO AN ALTERNATIVE EMBOLIC AGENT TO COMPLETE THE PROCEDURE. THIS RESULTED IN: ADDITIONAL PROCEDURAL TIME, USE OF AN ADDITIONAL EMBOLIC DEVICE, AND INCREASED PROCEDURAL COST TO THE FACILITY. NO USER ERROR WAS IDENTIFIED BY THE PHYSICIAN OR STAFF DURING PREPARATION OR EXTRACTION. THE PHYSICIAN SUGGESTED CONSIDERING FILLING THE VIAL WITH THE FULL LABELED 2.0 ML OR A SLIGHT OVERFILL TO ENSURE THAT THE FULL 2.0 ML CAN BE CONSISTENTLY WITHDRAWN INTO SYRINGES FOR DELIVERY DURING PROCEDURES. THERE WAS NO NEGATIVE OUTCOME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561313 ↗
• MalfunctionFeb 12, 2026Product Quality Problem; Improper or Incorrect Procedure or Method

  THE CUSTOMER WAS UNABLE TO VISUALIZE THE LAVA UNDER THE FLUOROSCOPE. THE LAVA WAS MIXED USING A VORTEX MIXER FOR 5 MINUTES AND THEN USING THE MIXING KIT FOR 16 PASSES. THE CUSTOMER KNEW THE EMBOLIZATION WORKED AS THEY PUT SOME CONTRAST THROUGH THE BASE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323464 ↗
• MalfunctionFeb 12, 2026Ambient Temperature Problem

  UPON DELIVERY, LAVA WAS NEEDED RIGHT AWAY. THE DMSO WAS FROZEN SOLID AND NEEDED TO BE THAWED, THEREFORE DELAYING THE CASE. EXTRA DMSO WAS AVAILABLE AND USED WHILE THE FROZEN DMSO THAWED. AN IMPROVEMENT SUGGESTION WAS OFFERED TO CHANGE THE SHIPPING CONTENTS TO GUARANTEE THAT NO PRODUCT IS FROZEN UPON ARRIVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323106 ↗
• MalfunctionDec 9, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE PHYSICIAN NOTIFIED SIRTEX MEDICAL THAT ONE OF THE LAVA VIALS THEY HAD IN STOCK SEEMED VERY DILUTED AND APPEARED TO HAVE LITTLE TO NO TANTALUM IN IT. THE DEVICE WAS NOT USED ON THE PATIENT BUT THE PHYSICIAN MIXED THE DEVICE ON THE VORTEX MIXER FOR 20 MINUTES AND NOTED THE VIAL APPEARED "WATERED DOWN" AS THEY PREPARED TO ASPIRATE. ADDITIONALLY, THE PHYSICIAN PERFORMED THE MIXING USING THE MIXING KIT. THE PHYSICIAN PLACED THE DEVICE UNDER FLUOROSCOPY AND NOTED THAT IT WAS NOT RADIOPAQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757203 ↗
• MalfunctionNov 3, 2025Product Quality Problem; Short Fill; Product Quality Problem; Short Fill

  THE CUSTOMER WAS ONLY ABLE TO DRAW 1.6 ML OF THE LAVA-18, 2 ML VIAL. AN ADDITIONAL LAVA VIAL WAS NEEDED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457450 ↗
• MalfunctionSep 19, 2025Product Quality Problem; Product Quality Problem

  WHILE REMOVING AIR FROM THE SYRINGE FILLED WITH LAVA, THE SYRINGE PLUNGER FELL OUT AND APPROXIMATELY 1 ML OF LAVA WAS LOST ON THE TABLE. THERE WAS NO PATIENT CONTACT AND A PROCEDURAL DELAY OCCURRED WHILE A NEW VIAL OF LAVA/SYRINGE KIT WAS PREPARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097726 ↗
• MalfunctionAug 27, 2025Product Quality Problem; Product Quality Problem

  THE PHYSICIAN STATED HE LIKES THE LAVA PRODUCT BUT WOULD PREFER A DIFFERENT SYRINGE TO DELIVER THE PRODUCT. THE PHYSICIAN STATED THAT THE RUBBER FLANGE ON STOPPER OF SYRINGE STICKS WHEN TRYING TO ADMINISTER LAVA AND CAUSES A SMALL JUMP OF PLUNGER WHEN TRYING TO DELIVER PRODUCT. IT IS NOT AS SMOOTH AS OTHER PRODUCTS AND THE PHYSICIAN WORRIES ABOUT HIS CONTROL WITH THE LAVA SYRINGE AS THE STICKING OF PLUNGER CAUSES A JUMP ON SYRINGE WHEN TRYING TO DELIVER THE LAVA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907570 ↗
• MalfunctionJul 30, 2025Failure to Transmit Record; Device Dislodged or Dislocated; Failure to Transmit Record; Device Dislodged or Dislocated

  COULD NOT VISUAL THE LAVA UNDER FLUOROSCOPY. INCIDENT OCCURRED WHEN THE LAVA WAS INJECTED INTO THE TARGET VASCULATURE THAT WAS TO BE EMBOLIZED. THERE WAS A BRANCH THAT SHOWED SOME LAVA ON ANGIO WHERE THE PHYSICIAN DID NOT INTEND IT TO GO. PATIENT WAS FINE AFTER THE PROCEDURE BUT WAS GOING TO BE MONITORED FOR ANY COMPLICATIONS AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667933 ↗
• MalfunctionJul 30, 2025No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER WAS ONLY ABLE TO GET 1.2 ML OUT OF THE 2ML-18 VIAL DURING CASE. PHYSICIAN WAS UPSET AND UNABLE TO USE LAVA ON ADDITIONAL VESSEL AND STATED THE PATIENT MIGHT HAVE TO COME BACK IN AND GET RE-TREATED WITH LAVA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667860 ↗
• MalfunctionJul 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  TWO VIALS (ONE - 2 ML VIAL OF LAVA-18 AND ONE-2 ML VIAL OF LAVA 34) WERE PLACED ON THE SMALL VORTEX ADAPTER AND THE VORTEX MIXER WAS TURNED ON AT THE APPROPRIATE SPEED. ABOUT 12 MINUTES AFTER THE VIALS WERE PLACED ON THE MIXER, IT MADE A LOUD NOISE AND THE LAVA-18 VIAL CAME OFF OF THE VORTEX. THE STERILE BLUE CAP WAS KNOCKED OFF AND WAS NOT USED AND THE OTHER VIAL WAS FOR ADMINISTRATION. BEFORE PLACING THE VIAL ON THE VORTEX TO COMPLETE THE MIXING, THE UNAFFECTED VIAL WAS TAPED TO THE ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667845 ↗
• InjuryMay 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  DOCTOR WAS ADMINISTERING DMSO/LAVA TO PATIENT. PATIENT WAS ON ANESTHESIA. DURING THE ADMINISTRATION PROCESS, ABOUT 20 MINUTES AFTER THE LAVA PRODUCT WAS ADMINISTERED, THE PATIENT EXPERIENCED A DROP IN HR AND BECAME STEMI. THE IR MD DOES NOT THINK THAT THE DMSO OR THE LAVA WERE CONTRIBUTORY TO THE DROP IN HR AND THE DROP SEEMED TO COINCIDE WITH THE ADMINISTRATION OF SOME HEPARIN TO THE PATIENT. HOWEVER, SINCE LAVA WAS BEING USED IN PROXIMITY TO THE DROP IN HR, THE DOCTOR COULD NOT RULE IT OUT.

  Patient problems: Myocardial Infarction

  MAUDE report 19259542 ↗