TRUFILL 632500NARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704085317), received between Mar 26, 2024 and Jun 16, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (P990040); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Unexpected Color

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE START OF AN ENDOVASCULAR EMBOLIZATION TARGETING THE MIDDLE MENINGEAL ARTERY (MMA), THE PHYSICIAN WAS GOING TO USE THE TRUFILL. HE OPENED THE BOX FOR THE TRUFILL¿ N-BCA 1-GRAM KIT LIQUID EMBOLIC SYSTEM (632500NA / MG3053), AND EVERYTHING WAS INTACT. THE PHYSICIAN WENT THROUGH THE PROCEDURAL STEPS TO PREP THE GLUE AND WHEN HE FILLED THE SYRINGE WITH DEXTROSE 5% IN WATER (D5W), HE LET IT SIT FOR A BIT WHILE CHECKING THE CATHETER POSITION. IT WAS THEN THE PHYSICIAN NOTICED THAT THE D5W IN THE SYRINGE BECAME CLOUDY AND FOAMY. THE ISSUE WAS NOTICED BEFORE USING THE SYRINGE IN THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT. ON 08-JUN-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE REPLACEMENT WAS ANOTHER TRUFILL¿ N-BCA 1-GRAM KIT LIQUID EMBOLIC SYSTEM (632500NA). THERE WERE NO DISCREPANCIES OR ABNORMALITIES NOTED WITH ANY OF THE COMPONENTS PRIOR TO USE OR DURING MIXING. THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT. THERE WAS A SLIGHT DELAY IN GETTING [THEIR OWN] SYRINGE KIT BUT NOT ANYTHING PROLONGED. ON 16-JUN-2026, ADDITIONAL INFORMATION WAS OBTAINED. PER THE INFORMATION, THE SYRING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521781 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE LUER LOCK ON THE SYRINGE OF THE TRUFILL¿ N-BCA 1-GRAM KIT LIQUID EMBOLIC SYSTEM (632500NA / MF7746) WAS FAULTY AND AS A RESULT THE GLUE LEAKED OUT OF THE SYRINGE WITH THE SELF-PIERCING LUER LOCK. THE PROCEDURE WAS REPORTED TO HAVE SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THERE WAS NO DELAY IN THE PROCEDURE. ON 15-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE MIDDLE MENINGEAL ARTERY (MMA). THE REPORTED ISSUE OCCURRED DURING THE MIXING OF THE GLUE; NO PATIENT WAS INVOLVED. THE PROCEDURE WAS COMPLETED WITH THE USE OF A NEW TRUFILL¿ N-BCA 1-GRAM KIT. THERE WAS ZERO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945506 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE SYRINGE IN THE TRUFILL¿ N-BCA 1-GRAM KIT LIQUID EMBOLIC SYSTEM (632500NA / MF5012) WAS FAULTY AND THE GLUE CAME OUT OF THE SYRINGE. THE ISSUE WAS DISCOVERED BEFORE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562294 ↗
• MalfunctionSep 2, 2025Chemical Problem; Chemical Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN WAS USING A 156CM HEADWAY® DUO MICROCATHETER (TERUMO NEURO) TO DELIVER THE TRUFILL¿ N-BCA 1-GRAM KIT LIQUID EMBOLIC SYSTEM (632500NA / M9571J). THE TECH AT THE TABLE NOTICED SIGNIFICANT REFLUX BACK ALONG THE LENGTH OF THE CATHETER AND POINTED IT OUT TO THE PHYSICIAN. HE SUGGESTED THAT SHE PULL BACK ON HER CATHETER TO MAKE SURE IT WAS STILL MOVING FREELY. PHYSICIAN SAID IT WAS FINE AND CONTINUED HER INJECTION. ONCE THE PHYSICIAN COMPLETED THE INJECTION, SHE TRIED TO REMOVE THE HEADWAY DUO MICROCATHETER, AND IT WAS STUCK. THE PHYSICIAN CONTINUED TO PULL, THE MICROCATHETER WAS REMOVED, BUT IT WAS NOTED THAT THE TIP OF THE MICROCATHETER HAD DETACHED AND WAS IN THE PATIENT. THE PORTION OF THE MICROCATHETER THAT REMAINED IN THE PATIENT WAS NOT INTRACRANIAL, SO NO ATTEMPT WAS MADE TO REMOVE IT SURGICALLY. THE REPORTER STATED THAT THE PHYSICIAN WAS ¿CERTAIN THAT THE [MICROCATHETER] WAS THE PROBLEM.¿ THE PATIENT IS REPORTED TO BE DOING ¿FINE.¿ THE PROCEDURE WAS COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939548 ↗
• MalfunctionMar 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, RELATING TO 1 NBCA, TA, OIL, & ACCESSORIES (632500NA, UNKNOWN LOT), THE 1CC SYRINGE IN PARTICULAR BOTH FOR INJECTION AND MIXING, "THE PLUNGER IS WEAK AND IT'S NOT A TIGHT FIT SO THE TRUFILL CASE LEAK OUT THE BACK OF THE SYRINGE". NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977626 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990040. One submission often covers many models, so check the product and lot details in each record.

• Z-0788-2014 · Oct 11, 2013 · Terminated
  TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400;
• Z-0789-2014 · Oct 11, 2013 · Terminated
  TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 Th