TRUFILL 631-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886704029151), received between Nov 15, 2017 and Jan 13, 2026 — classified as 14 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (6 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Device Ingredient or Reagent Problem; Unexpected Color

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PREPPING OF A TRUFILL N-BCA-1 GRAM KIT (PRODUCT CODE: 631500, LOT NUMBER: MD3674), THE MIXTURE OF N-BCA AND ETHIODIZED OIL APPEARED CLOUDY AND NOT STICKY AS USUAL AFTER BEING LEFT ON A SEPARATE TABLE FOR APPROXIMATELY 45 MINUTES. THE MIXTURE WAS STIRRED USING THE BACK OF A SYRINGE PLUNGER, AND UPON ATTEMPTED DRAW-UP INTO A SYRINGE, SMALL THICKER, PARTICULATE-APPEARING AREAS WERE OBSERVED. DUE TO THIS APPEARANCE, THE PRODUCT WAS NOT USED, AND A NEW BOX OF THE SAME PRODUCT WAS OPENED INSTEAD. THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCE, AND THE COMPLAINT DEVICE WAS NOT USED IN THE PROCEDURE. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-JAN-2025 INDICATED/CLARIFIED THAT THE N-BCA WAS PREPARED IN A STERILE METAL MIXING CUP, PER THE HOSPITAL¿S STANDARD PROCESS. THE MIXTURE CONSISTED OF 4ML ETHIODIZED OIL AND N-BCA. THE MIXTURE WAS STIRRED USING THE BACK OF A SYRINGE PLUNGER, NOT A METAL ROD, AS PER USUAL PROTOCOL. THE PREPARED MIXTURE WAS LEFT ON THE SEPARATE EMBOLIC TABLE FOR APPROXIMATELY 45 MINUTES BEFORE ATTEMPTED DRAW-UP VIA NEW SYRINGE. WHEN THE TECHNOLOGIST ATTEMPTED TO DRAW THE MIXTURE INTO A SYRINGE, THE MIXTURE APPEARED CLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053940 ↗
• MalfunctionNov 17, 2025Unexpected Color; Unexpected Color

  A HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO GETTING ACCESS IN MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION, THE PHYSICIAN WENT TO MIX UP TRUFILL N-BCA-1 GRAM KIT (631500, MC4030) TRUFILL NBCA FOR THE PROCEDURE. WHILE HE WAS DRAWING UP THE NBCA FROM THE TUBE, HE NOTICED THAT THE COLOR AND CONSISTENCY WAS OFF FROM NORMAL. AT THIS POINT HE DISCARDED THE ORIGINAL PRODUCT AND OPENED A NEW KIT. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING AND THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 10-NOV-2025 AND 13-NOV-2025 INDICATED THAT THE NBCA GLUE WAS DISCOLORED. THE USER NOTICED AS HE WAS DRAWING THE GLUE OUT OF THE TUBE INTO A SYRINGE. IT WAS NEVER MIXED WITH THE OTHER COMPONENTS. IT WAS CONFIRMED THAT THE LIPOIDAL WAS NOT IMPLICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571984 ↗
• MalfunctionAug 26, 2025Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT THE PHYSICIAN AND THE LAB STAFF ARE EXPERIENCED WHEN IT COMES TO THE MIXING AND USAGE OF THE TRUFILL NBCA. DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE THAT WAS USING A TRUFILL® N-BCA LIQUID EMBOLIC SYSTEM-1 GRAM KIT (631500 / M85H78), AFTER MIXING THE NBCA AND ETHIODIZED OIL, THE PHYSICIAN AND LAB NOTICED A MILKY CONSISTENCY. THIS WAS AN INDICATION THAT THE MIXTURE HAD COME INTO CONTACT WITH AN IONIC SUBSTANCE, LIKE BLOOD, SALINE OR CONTRAST MEDIA. IT WAS REPORTED THAT THE TECH ¿FEELS SURE THAT DID NOT HAPPEN.¿ THEY DISCARDED THE FIRST KIT / MIXTURE AND USED ANOTHER TRUFILL NBCA KIT WITHOUT ANY ISSUE. THE MIXTURE WITH THE REPORTED ISSUE WAS NEVER USED; THE CASE WAS COMPLETED WITH A NEW TRUFILL KIT. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT OR ANY DELAY. ON 22-AUG-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THERE WERE NO DISCREPANCIES OR ABNORMALITIES NOTED WITH ANY OF THE COMPONENTS PRIOR TO USE OR DURING MIXING. IT IS NOT KNOWN IF THE LOT NUMBER OF THE NBCA KIT USED TO COMPLETE THE PROCEDURE IS FROM THE SAME LOT NUMBER: (M85H78). THE REPORTED ISSUE DID NOT RESULT IN ANY PROCEDURE DELAY. ON 26-AUG-2025, ADDITIONAL INFORMATION WAS RECEIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900881 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE MEMBRANE STUDY, A 77-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF CARDIAC ARRHYTHMIA, HEADACHES, CONTROLLED HYPERTENSION, UNDERWENT EVACUATION OF A CHRONIC SUBDURAL HEMATOMA (SDH) VIA TWO BURR HOLES PLACEMENT FOR A LEFT FRONTAL SUBDURAL HEMATOMA WITH PARIETAL INVOLVEMENT ON (B)(6) 2023. THE PATIENT WAS RANDOMIZED INTO THE SURGICAL AND MMA EMBOLIZATION COHORT OF THE STUDY. THE PATIENT¿S BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 0 AND THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 1. THE SDH THICKNESS WAS 10.5MM. ON (B)(6) 2023, THE PATIENT UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION VIA RIGHT FEMORAL ACCESS. THE TRUFILL® N-BCA LIQUID EMBOLIC SYSTEM-1 GRAM KIT (631500 / M39Z36) (3:1 OIL: N-BCA RATIO) WAS DELIVERED WITHOUT REACHING MIDLINE VIA AN ECHELON 10 (MEDTRONIC). THE ANTERIOR BRANCH OF THE MMA WAS EMBOLIZED. NON-TARGET VESSEL EMBOLIZATION DID NOT OCCUR. IN THE OPINION OF THE TREATING PHYSICIAN, THE EMBOLIZATION WAS SUCCESSFUL. THE PATIENT WAS DISCHARGED ON (B)(6) 2023. THE MINI-MENTAL STATE EXAM (MMSE), MARKWALDER GRADING SCALE (MGS), AND MODIFIED RANKIN SCALE (MRS) ASSESSMENTS WERE NOT PERFORMED. ON (B)(6) 2023, THE PATIENT EXPERIE

  Patient problems: Convulsion/Seizure

  MAUDE report 21913314 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE MEMBRANE STUDY, A 52-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF HEADACHES AND PREVIOUS HEAD INJURY WITHIN THE PAST 12 MONTHS, UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A RIGHT PARIETAL SUBDURAL HEMATOMA (SDH) WITH FRONTAL INVOLVEMENT WITH TWO BURR HOLE PLACEMENT ON (B)(6) 2022. THE PATIENT WAS RANDOMIZED INTO THE SURGICAL AND MMA EMBOLIZATION COHORT OF THE STUDY. THE PATIENT¿S BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 1 AND THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE SDH THICKNESS WAS 9.7MM. THE MMA EMBOLIZATION STUDY PROCEDURE WAS PERFORMED ON (B)(6) 2022 VIA RIGHT FEMORAL ACCESS. TRUFILL N-BCA-1 GRAM KIT (631500 / JM3688) (2.2:1 OIL: N-BCA RATIO) WAS DELIVERED BEYOND MIDLINE VIA AN ECHELON 10 MICROCATHETER (MEDTRONIC) AND A MARATHON MICROCATHETER (MEDTRONIC). THE ANTERIOR AND POSTERIOR BRANCHES OF THE MMA WERE EMBOLIZED. IN THE OPINION OF THE TREATING PHYSICIAN, THE EMBOLIZATION WAS SUCCESSFUL. THE PATIENT WAS DISCHARGED HOME FOR SELF-CARE ON (B)(6) 2022 WITH A MINI-MENTAL STATE EXAM (MMSE) SCORE OF 30, A MARKWALDER GRADING SCALE (MGS) SCORE OF 1, AND A MODIFIED RANKIN SCALE (MRS) SCORE OF 2. ON (B)(6) 2022, 16 DAYS AFT

  Patient problems: Convulsion/Seizure; Headache

  MAUDE report 21912926 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE MEMBRANE STUDY, A 79-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF HYPERTENSION (CONTROLLED), SEIZURES, PREVIOUS SMOKER, CORONARY ARTERY DISEASE (CAD), AND VALVE DISEASE/DYSFUNCTION, UNDERWENT EVACUATION OF A CHRONIC SUBDURAL HEMATOMA (SDH) VIA ONE BURR HOLE AND EXTERNAL VENTRICULAR DRAINS (EVD) PLACEMENT FOR A LEFT FRONTAL SUBDURAL HEMATOMA ON (B)(6) 2022. THE PATIENT WAS RANDOMIZED INTO THE SURGICAL AND MMA EMBOLIZATION COHORT OF THE STUDY. THE PATIENT¿S BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 1 AND THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 2. THE SDH THICKNESS WAS 25.0MM. ON (B)(6) 2022, THE PATIENT UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION VIA RIGHT RADIAL ACCESS. THE TRUFILL® N-BCA LIQUID EMBOLIC SYSTEM-1 GRAM KIT (631500 / JM5177) (4:1 OIL: N-BCA RATIO) WAS DELIVERED WITHOUT REACHING MIDLINE VIA A HEADWAY DUO MICROCATHETER (MICROVENTION). THE ANTERIOR BRANCH OF THE MMA WAS EMBOLIZED. NON-TARGET VESSEL EMBOLIZATION DID NOT OCCUR, AND THE N-BCA WAS INJECTED INTO THE BLOOD VESSEL BEYOND THE TIP OF THE MICROCATHETER. IN THE OPINION OF THE TREATING PHYSICIAN, THE EMBOLIZATION WAS SUCCESSFUL. THE PATIENT WAS DISCHARGED ON (B)(6)

  Patient problems: Pulmonary Embolism

  MAUDE report 21912906 ↗
• MalfunctionAug 6, 2024Chemical Problem; Chemical Problem

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, THE GLUE OF A TRUFILL N-BCA-1 GRAM KIT (631500, M25F70) BECAME OCCLUDED INSIDE THE CATHETER. SURGERY WAS DELAYED DUE TO THE EVENT. THE UNSPECIFIED MICROCATHETER WAS REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917996 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE MEMBRANE STUDY, A 72-YEAR-OLD MALE SUBJECT WITH A HISTORY OF CONGESTIVE HEART FAILURE, CORONARY ARTERY DISEASE (CAD), HEADACHES, HEAD INJURY WITHIN THE PAST 12 MONTHS, CONTROLLED HYPERTENSION (10 YEARS), PREVIOUS SMOKER, TRANSIENT ISCHEMIC ATTACK (TIA), VALVE DISEASE/DYSFUNCTION WAS RANDOMIZED INTO THE NON-SURGICAL AND MMA EMBOLIZATION COHORT OF THE STUDY. THE PATIENT¿S BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 1 AND THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 2. ON (B)(6) 2023, THE PATIENT UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A RIGHT FRONTAL SUBDURAL HEMATOMA (SDH) WITH PARIETAL INVOLVEMENT. THE PROCEDURE WAS VIA RIGHT FEMORAL ACCESS. THE TRUFILL® N-BCA LIQUID EMBOLIC SYSTEM-1 GRAM KIT (631500 / M16Z21) (5:1 OIL: N-BCA RATIO) WAS DELIVERED TO MIDLINE VIA A HEADWAY DUO MICROCATHETER (MICROVENTION). THE ANTERIOR AND POSTERIOR BRANCHES OF THE MMA WERE EMBOLIZED. IN THE OPINION OF THE TREATING PHYSICIAN, THE EMBOLIZATION WAS SUCCESSFUL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023 WITH A MINI-MENTAL STATE EXAM (MMSE) SCORE OF 28, A MARKWALDER GRADING SCALE (MGS) SCORE OF 1, AND A MODIFIED RANKIN SCALE (MRS) SCORE O

  Patient problems: Convulsion/Seizure

  MAUDE report 19576281 ↗
• MalfunctionJun 18, 2024Chemical Problem; Chemical Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TARGETING THE MIDDLE MENINGEAL ARTERY, THE PHYSICIAN WAS USING THE TRUFILL N-BCA 1 GRAM KIT (631500 / M64G35). THE PHYSICIAN INJECTED A RATIO OF FOUR-TO-ONE ETHIODIZED OIL TO GLUE AND WHEN HE REMOVED THE MICROCATHETER, THE GLUE DID NOT POLYMERIZE AND IT DRIFTED DISTALLY TO A NON-TARGET AREA. THE PHYSICIAN DID ANOTHER INJECTION WITH THIS SAME MIXTURE OF GLUE AND EXPERIENCED THE SAME RESULT. HE THEN OPENED ANOTHER BOX OF TRUFILL N-BCA AND MIXED THE SAME RATION OF OIL-TO-GLUE; THIS TIME, THE GLUE POLYMERIZED APPROPRIATELY. THE PHYSICIAN STATED THAT THERE WAS ¿SOMETHING WRONG WITH THE FIRST KIT OF GLUE AND HE WOULD LIKE IT REPLACED.¿ THERE WAS NO REPORT OF ANY PATIENT HARM. ON 17-JUN-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PATIENT IS AN 8-YEAR-OLD MALE WHO WAS TREATED DUE TO A SPONTANEOUS SUB-DURAL BLEED. THERE WERE NO DISCREPANCIES NOR ABNORMALITIES NOTED WITH ANY OF THE COMPONENTS PRIOR TO USE OR DURING MIXING. THE MICROCATHETER USED WAS AN ECHELON¿ 14 MICROCATHETER (MEDTRONIC). THE PHYSICIAN USED A NEW ECHELON 14 MICROCATHETER FOR EVERY INJECTION. THE REPLACEMENT BOX WAS FROM LO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563682 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE MEMBRANE STUDY, AN 82-YEAR-OLD FEMALE (SUBJECT (B)(6)) WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE AND HYPERTENSION (CONTROLLED), UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A LEFT FRONTAL SUBDURAL HEMATOMA (SDH) WITH TEMPORAL AND PARIETAL INVOLVEMENT ON (B)(6) 2023. THE PATIENT WAS RANDOMIZED INTO THE NON-SURGICAL AND MMA EMBOLIZATION COHORT OF THE STUDY. THE PATIENT¿S BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 0 AND THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE SDH THICKNESS WAS 11. THE MMA EMBOLIZATION STUDY PROCEDURE WAS PERFORMED ON (B)(6) 2023 VIA RIGHT FEMORAL ACCESS. TRUFILL N-BCA-1 GRAM KIT (631500/M4378T) (4:1 OIL: N-BCA RATIO) WAS DELIVERED TO MIDLINE VIA A HEADWAY DUO (MICROVENTION). THE ANTERIOR AND POSTERIOR BRANCHES OF THE MMA WERE EMBOLIZED. IN THE OPINION OF THE TREATING PHYSICIAN, THE EMBOLIZATION WAS SUCCESSFUL. THE EVENT OF ¿INCREASED CONFUSION,¿ WHICH STARTED ON 10-NOV-2023, WAS ASSESSED BY THE PI AS A SERIOUS, SEVERE ADVERSE EVENT, AND AS NOT RELATED TO THE STUDY DEVICE, POSSIBLY RELATED TO THE MMA EMBOLIZATION PROCEDURE, NOT RELATED TO THE MEDICATION USED TO TREAT THE SUBDURAL HEMATOMA (SDH), AND POSSIBLY RELATE

  Patient problems: Confusion/ Disorientation; Convulsion/Seizure; Stroke/CVA

  MAUDE report 18239745 ↗
• MalfunctionNov 9, 2023Chemical Problem; Chemical Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT A TRUFILL N-BCA-1 GRAM KIT (631500/LOT # UNKNOWN) WAS USED FOR AN ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION PROCEDURE ON A 16-YEAR-OLD MALE PATIENT, DURING WHICH THE USER REPORTED ¿TRUFILL MIXED AT 4:1 RATIO WITH SOME TANTALUM POWDER¿ POLYMERIZED TOO FAST IN THE MICROCATHETER. THE USER REPORTED TO HAVE FLUSHED THE BALT MAGIC MICROCATHETER WITH DEXTROSE 5% SOLUTION, AND INJECT THE TRUFILL N-BCA LIQUID EMBOLIC AGENT, WHICH THEN ¿ALMOST IMMEDIATELY CLOGGED COMPLETELY INSIDE THE MICROCATHETER LUMEN¿. THE EVENT WAS SAID TO HAVE DELAYED THE SURGICAL PROCEDURE BY 10 MINUTES. A NEW MICROCATHETER AND A NEW TRUFILL N-BCA-1 GRAM KIT HAD TO BE USED INSTEAD TO COMPLETE THE PROCEDURE. THE TREATING PHYSICIAN FURTHER COMMENTED THAT ¿IF HE HAD USED ONYX THE PROCEDURE WOULD HAVE ALREADY BEEN FINISHED WITHOUT DELAY¿. THE EVENT DID NOT RESULT IN PATIENT INJURY, DEATH, ADDITIONAL INTERVENTION TO PRECLUDE SERIOUS INJURY OR DEATH, HOSPITALIZATION, PROLONGATION OF EXISTING HOSPITALIZATION, OR PERMANENT DISABILITY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104834 ↗
• InjurySep 8, 2023Chemical Problem; Chemical Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT VEIN OF GALEN MALFORMATION (VOGM) IN A 12-DAY OLD PATIENT, THE PHYSICIAN USED A MIXTURE OF TRUFILL¿ N-BCA 1-GRAM KIT LIQUID EMBOLIC SYSTEM (631500/LOT# UNKNOWN) AND TANTALUM POWDER WITHOUT ANY ETHIODIZED OIL. IT WAS REPORTED THAT THE PHYSICIAN WAS INFORMED THAT IT WAS CONTRAINDICATED TO USE THE N-BCA WITHOUT THE OIL. THE PHYSICIAN REPORTED THAT THE N-BCA/TANTALUM MIXTURE NEVER EXITED THE MICROCATHETER (UNSPECIFIED BRAND). THE PHYSICIAN USED DEXTROSE 5% IN WATER (DW5) TO RINSE THE HUB AND THE INNER LUMEN OF THE MICROCATHETER BEFORE INJECTION OF THE N-BCA/TANTALUM MIXTURE. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED WITH A LESS THAN DESIRABLE TREATMENT OUTCOME; NO REASON WAS REPORTED AT THE TIME OF THE COMPLAINT INITIATION. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT; NO OTHER MEDICAL INTERVENTION REQUIRED.

  Patient problems: Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions; Perforation of Vessels; Respiratory Failure

  MAUDE report 17716139 ↗
• MalfunctionAug 17, 2023Chemical Problem; Chemical Problem

  AS REPORTED BY THE FIELD, TRUFILL N-BCA-1 GRAM KIT (631500, M24X45) WAS BEING USED FOR A SUBARACHNOID HEMORRHAGE AND A PSEUDOANEURYSM OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PHYSICIAN STATED IT WAS "NOT IDEAL". THE PHYSICIAN DID NOT STATE TO MANAGER ANY RATIO HE WAS USING. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIAN TESTED THE PURE GLUE ITSELF. GLUE APPLIED TO STERILE GLOVE PRE TREATED WITH SALINE. GLUE DID NOT POLYMERIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17565423 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE MEMBRANE (B)(4) STUDY, A 64-YEAR-OLD MALE (B)(6) WITH A HISTORY OF CARDIAC ARRHYTHMIA, CONGESTIVE HEART FAILURE, CORONARY ARTERY DISEASE, CHRONIC RENAL FAILURE, A COVID 19 POSITIVE, DIABETES, HYPERTENSION (CONTROLLED) AND PREVIOUS SMOKER, UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A RIGHT FRONTO-TEMPORAL SUBDURAL HEMATOMA (SDH) ON (B)(4)2023. THE PATIENT WAS RANDOMIZED INTO THE SURGERY + MMA EMBOLIZATION COHORT OF THE STUDY. THE PATIENT¿S BASELINE GLASGOW COMA SCALE (GCS) SCORE WAS 14, MINI MENTAL STATE EXAM (MMSE) SCORE WAS 23. MARKWALDER GRADING SCALE (MGS) SCORE WAS 2 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 3. THE SDH THICKNESS WAS 20.9MM. THE MMA EMBOLIZATION STUDY PROCEDURE WAS PERFORMED VIA RIGHT FEMORAL ACCESS. TRUFILL N-BCA 1X1 GRAM GLUE (CATALOG: 631500/LOT: JP3682), (4:1 OIL: N-BCA RATIO) WAS DELIVERED VIA A HEADWAY DUO (MICROVENTION). THE ANTERIOR AND POSTERIOR BRANCHES OF THE MMA WERE EMBOLIZED. IN THE OPINION OF THE TREATING PHYSICIAN THE EMBOLIZATION WAS SUCCESSFUL. ON (B)(4) 2023 THE PATIENT EXPERIENCED AN WORSENED HEADACHE, WHICH WAS ASSESSED BY THE PRINCIPAL INVESTIGATOR AS MODERATE IN SEVERITY, NOT SERIOUS. POSSIBLY RELATED TO TH

  Patient problems: Headache

  MAUDE report 16618642 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE MEMBRANE STUDY. THE 37-YEAR-OLD MALE SUBJECT WITH A HISTORY OF DIABETES UNDERWENT A CRANIOTOMY OF THE RIGHT AND FRONTAL PARIETAL SIDE ON (B)(6) 2022. THE PATIENT WAS RANDOMIZED INTO THE SURGERY + MMA EMBOLIZATION COHORT OF THE STUDY. HIS BASELINE GLASGOW COMA SCALE (GCS) SCORE WAS 15, MINI-MENTAL STATE EXAM (MMSE) SCORE WAS 23, MARKWALDER GRADING SCALE (MGS) SCORE WAS 0 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 1. THE HEMATOMA THICKNESS WAS 14 MM ON THE BASELINE CT SCAN. THE PATIENT UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A RIGHT FRONTAL AND PARIETAL SUBDURAL HEMATOMA (SDH) ON (B)(6) 2022. ON (B)(6) 2022, THE MMA EMBOLIZATION STUDY PROCEDURE WAS PERFORMED USING RIGHT FEMORAL ACCESS. THE TRUFILL N-BCA 1X1 GRAM (631500 / M05F16) (3:1 OIL: N-BCA RATIO) WAS DELIVERED VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) MICROCATHETER. A CEREBASE GUIDE SHEATH OR ENVOY GUIDE CATHETER (DA OR GC) WAS USED DURING THE PROCEDURE. THE ANTERIOR AND POSTERIOR BRANCHES AND ORIGIN OF THE MMA WERE EMBOLIZED. PENETRATION WITHOUT REACHING THE MIDLINE WAS PERFORMED AS THE EMBOLIZATION TECHNIQUE. NO VASOSPASM OCCURRED DURING THE PROCEDURE. IN THE OPINION OF THE

  Patient problems: Nerve Damage

  MAUDE report 16107919 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE MEMBRANE STUDY. A 69-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CONTROLLED HYPERTENSION UNDERWENT MENINGEAL ARTERY (MMA) EMBOLIZATION USING THE TRUFILL N-BCA (631500 / JY1048) ON (B)(6) 2022. THE PATIENT EXPERIENCED LEFT-SIDED HEADACHE ON THE SAME DAY AS THE SURGERY, WHICH WAS REPORTED TO BE MODERATE. THE EVENT WAS EVALUATED AS POSSIBLY RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE. IT WAS REPORTED AS NOT RELATED TO THE SUBDURAL HEMATOMA (SDH) MEDICATION. THE PATIENT WAS PRESCRIBED MEDICATION FOR THE REPORTED HEADACHE AND THE EVENT RESOLVED.

  Patient problems: Headache

  MAUDE report 15615654 ↗
• MalfunctionSep 23, 2022Chemical Problem; Chemical Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TREATING A DUODENAL PERFORATION IN THE 62-YEAR-OLD FEMALE PATIENT WITH PANCREATITIS, THE TRUFILL N-BCA (631500 / M0070X) DID NOT POLYMERIZE IN THE SPEED DESIRED BY THE PHYSICIAN. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THE PATIENT IS REPORTED TO BE STABLE AND HAD RESOLUTION OF ISSUES. THE PATIENT IS CURRENTLY UNDER OBSERVATION AND IS STABLE WITHOUT KNOWN COMPLICATION. THERE WAS NO REPORT OF ANY DELAY IN THE PROCEDURE. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THE PATIENT IS A 62-YEAR-OLD FEMALE WITH RETROPERITONEAL DUODENAL PERFORATION. THE PRODUCT WAS INJECTED IN AN AREA THAT WAS DESCRIBED AS NOT HIGH FLOW NOR SLOW FLOW. THE RATIO OF NBCA TO ETHIODIZED OIL AND TANTALUM POWDER WAS 1:5:1. THE MIXTURE WAS PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU). THE INFORMATION INDICATED THAT NO TANTALUM USED AND AN APPROPRIATE MATERIAL SPECIMEN CUP WAS USED AND HOMOGENOUS MIXTURE WAS CONFIRMED. IT WAS REPORTED THAT THE POLYMERIZATION WAS NOT AT THE DESIRED SPEED; IT WAS TOO SLOW. THE GLUE SOLIDIFIED IN A BRANCH VESSEL IN THE PATIENT. THERE WAS NO INJURY TO THE PATIENT. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470831 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE MEMBRANE STUDY, A 69-YEAR-OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF TESTING POSITIVE FOR COVID 19 AND SUBARACHNOID HEMORRHAGE (SAH) UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A LEFT FRONTAL SUBDURAL HEMATOMA (SDH) ON (B)(6)2022. THE PATIENT WAS RANDOMIZED INTO THE NON-SURGICAL MEDICAL MANAGEMENT (NSMM) AND MMA EMBOLIZATION COHORT OF THE STUDY. THE PATIENT¿S BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 1 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 2. THE SDH THICKNESS WAS 21 MM AND VOLUME 64 ML. THE MMA EMBOLIZATION STUDY PROCEDURE WAS PERFORMED VIA THE RIGHT RADIAL ACCESS. TRUFILL N-BCA 1X1 GRAM GLUE (LOT # JY1048) (4:1 OIL: N-BCA RATIO) WAS DELIVERED BILATERALLY VIA A HEADWAY DUO (MICROVENTION). COILS WERE ALSO IMPLANTED DUE TO THE INABILITY TO NAVIGATE THE CATHETER TO THE APPROPRIATE N-BCA INJECTION POSITION. IN THE OPINION OF THE TREATING PHYSICIAN, THE EMBOLIZATION WAS SUCCESSFUL. ON (B)(6) 2022 THE PATIENT EXPERIENCED A FRONTAL HEADACHE, WHICH WAS ASSESSED BY THE PRINCIPAL INVESTIGATOR AS MILD IN SEVERITY, NOT SERIOUS, POSSIBLY RELATED TO THE STUDY DEVICE, POSSIBLE RELATED TO THE MMA EMBOLIZATION STUDY PROCEDURE, NOT RELATED TO THE SDH M

  Patient problems: Headache

  MAUDE report 15184369 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE MEMBRANE STUDY, AN (B)(6) MALE (SUBJECT (B)(6) WITH A HISTORY OF A HEAD INJURY WITHIN THE PAST 12 MONTHS, HYDROCEPHALUS, AND SMOKING UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A RIGHT SUBDURAL HEMATOMA (SDH) ON (B)(6) 2022. THE PATIENT WAS RANDOMIZED INTO THE SURGERY + MMA EMBOLIZATION COHORT OF THE STUDY. HIS BASELINE GLASGOW COMA SCALE (GCS) SCORE WAS 14, MINI MENTAL STATE EXAM (MMSE) SCORE WAS 12, MARKWALDER GRADING SCALE (MGS) SCORE WAS 2 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 2. THE HEMATOMA THICKNESS WAS 18.3 MM ON THE BASELINE CT SCAN. SURGERY WAS PERFORMED ON (B)(6) 2022. ONE BURR HOLE WAS DRILLED INTO THE RIGHT SIDE OF THE FRONTAL AND PARIETAL SKULL AND A SUBGALEAL DRAIN WAS PLACED. THE MMA EMBOLIZATION STUDY PROCEDURE WAS PERFORMED ON (B)(6) 2022 USING RIGHT FEMORAL ACCESS. TRUFILL N-BCA 1X1 GRAM (631500/JD4687) (4:1 OIL: N-BCA RATIO) WAS DELIVERED VIA A HEADWAY DUO MICROCATHETER (MICROVENTION). THE ANTERIOR & POSTERIOR BRANCHES OF THE MMA WERE EMBOLIZED. THERE WAS NO VASOSPASM NOTED DURING THE PROCEDURE. IN THE OPINION OF THE TREATING PHYSICIAN, THE EMBOLIZATION WAS SUCCESSFUL. ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT EXP

  Patient problems: Distress

  MAUDE report 14376255 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE MEMBRANE STUDY, A 78-YEAR-OLD MALE (SUBJECT (B)(6)) WITH A HISTORY OF CARDIAC ARRHYTHMIA, CORONARY ARTERY DISEASE (CAD), DIABETES, HEAD INJURY WITHIN THE PAST 12 MONTHS, AND CONTROLLED HYPERTENSION UNDERWENT MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION OF A LEFT FRONTAL CHRONIC SUBDURAL HEMATOMA (CSDH) ON (B)(6) 2022 AND EXPERIENCED A RIGHT POSTERIOR CEREBRAL ARTERY INFARCT ON (B)(6) 2022. COMPUTED TOMOGRAPHY (CT) SCAN OF THE BRAIN WITHOUT CONTRAST WAS PERFORMED AS DIAGNOSTIC TEST/EVALUATION. THE EVENT HAS NOT RESOLVED. PER THE PRINCIPAL INVESTIGATOR (PI), THE EVENT WAS MODERATE IN SEVERITY AND POSSIBLY RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE (I.E., MMA EMBOLIZATION). THE EVENT WAS CONSIDERED SERIOUS BY THE PI AS THE EVENT REQUIRED PROLONGED HOSPITALIZATION. THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER ON (B)(6) 2022 WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 4. THE PATIENT WAS RANDOMIZED INTO THE NON-SURGICAL MEDICAL MANAGEMENT (NSMM) AND MMA EMBOLIZATION COHORT OF THE STUDY. HIS BASELINE MARKWALDER GRADING SCALE (MGS) SCORE WAS 1 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 2. THE CSDH THICKNESS WAS 17MM AND VOLUME 58.4ML. THE MMA EMBOLIZATION STUDY

  Patient problems: Ischemia Stroke

  MAUDE report 14143238 ↗
• InjuryOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE LITERATURE CITATION IS AS FOLLOWS: BAMEZAI S, ARONBERG RM, PARK JM, GEMMETE JJ. INTRANODAL LYMPHANGIOGRAPHY AND INTERSTITIAL LYMPHATIC EMBOLIZATION TO TREAT CHYLURIA CAUSED BY A LYMPHATIC MALFORMATION IN A PEDIATRIC PATIENT. PEDIATR RADIOL. 2021 AUG;51(9):1762-1765. DOI: 10.1007/S00247-021-05007-W. EPUB 2021 FEB 27. PMID: 33638694. OBJECTIVE AND METHODS: THE PURPOSE OF THE ARTICLE WAS TO PRESENT A PEDIATRIC CASE OF PERSISTENT CHYLURIA FROM A LYMPHATIC MALFORMATION WHICH REQUIRED INTRANODAL LYMPHANGIOGRAPHY AND INTERSTITIAL LYMPHATIC EMBOLIZATION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) EMBOLIC AGENT. OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: A (B)(6) YEAR-OLD BOY PRESENTED TO THE EMERGENCY DEPARTMENT WITH ONSET OF GROSS HEMATURIA AND A 3- MONTH HISTORY OF CHYLURIA. CYSTOSCOPY DEMONSTRATED MILKY URINE ENTERING THE BLADDER THROUGH THE LEFT URETERAL ORIFICE. INTRANODAL DYNAMIC CONT

  Patient problems: Embolism/Embolus

  MAUDE report 12604857 ↗
• MalfunctionApr 14, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  THE HEALTHCARE PROFESSIONAL REPORTED THAT AN ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION PROCEDURE WAS SCHEDULED TO TAKE PLACE. IT WAS REPORTED THAT DURING THE SET UP FOR THE PROCEDURE, UPON OPENING THE TRUFILL N-BCA 1 GRAM KIT UNIT BOX (631500 / J6593F), THE STERILE PACKAGING THAT HOLDS THE VIAL CONTAINING THE N-BCA LIQUID EMBOLIC APPEARED COMPROMISED. THE STERILE PACKAGING THAT HOLDS THE GLUE TUBE, WHICH IS NORMALLY CLEAR WITH WHITE LABEL, HAD A YELLOWISH APPEARANCE AND WAS CREASED. THE INNER POUCH SEAL OF THE STERILE PACKAGING WAS NOT OPEN BUT DUE TO THE YELLOWISH COLOR AND CREASED APPEARANCE, THEY SUSPECTED THAT THE STERILITY MAY HAVE BEEN COMPROMISED EVEN THOUGH THERE WAS NO ANOMALY WITH THE TUBE THAT CONTAINS THE ACTUAL GLUE. THERE WAS NO CRACKING OR LEAKING OBSERVED ON THE TUBE THAT CONTAINS THE GLUE. THE REPORTED ISSUE WAS ONLY TO THE INNER PACKAGING; THERE WAS NO DAMAGE TO THE SHIPPING BOX OR TO THE OUTER BOX OF THE PRODUCT. THE PACK WAS DISCARDED IMMEDIATELY, AND A NEW PACK WAS OPENED. IT WAS REPORTED THAT THE PRODUCT WAS STORED IN THE LAB PRIOR TO USE. IT WAS STORED ON A SHELF IN THE ROOM WITH A PAR LEVEL OF 4 BOXES. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9960147 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A (B)(6) YEAR-OLD MALE PATIENT WITH AN UNREPORTED MEDICAL HISTORY UNDERWENT A LEFT MIDDLE CEREBRAL ARTERY EMBOLIZATION USING NBCA GLUE (631500/HR1780 OR HP6250) AND 8 HOURS LATER DEVELOPED A SUBSEQUENT ISCHEMIC STROKE FROM THE EMBOLIC MATERIAL. THE PATHOLOGY REPORT CONFIRMED THAT THE EMBOLIC MATERIAL CAPTURED IN THROMBECTOMY WAS BLACK PIGMENTED AND SUGGESTIVE OF NBCA. IT WAS REPORTED THAT THE PRODUCT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Embolism; Infarction, Cerebral

  MAUDE report 8219405 ↗
• MalfunctionNov 15, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED BY A PHYSICIAN, WHEN INJECTING GLUE WITH TANTALUM AND APROX 1/2 CC TO 1CC OF OIL, THE GLUE WAS NOT VISIBLE AS INJECTING UNDER FLURO. PRODUCT INCLUDED TRUFILL NBCA 1 GRAM KIT (631500/ HA2573 X 2, 631500/ HF2890 X 1, AND UNKNOWN CATALOG/LOT X 1). THE EMBOLIZATION PROCEDURE WAS FOR TREATMENT OF VEIN OF GALIN ON A (B)(6) INFANT. THE PHYSICIAN, WHO HAS BEEN SUCCESSFULLY BEEN USING NBCA GLUE FOR MANY YEARS, ADDED THE ENTIRE PACKET OF TANTALUM POWDER WITH OIL (APPROX. ½ CC TO 1CC OF OIL) TO THE NBCA GLUE IN A GLASS BEAKER. THE RADIOPACITY OF THE MIXTURE WAS NOT CONFIRMED VIA FLOURO PRIOR TO INJECTION BY COMPARING THE GLUE TO A SIMILAR SYRINGE CONTAINING CONTRAST AS INSTRUCTED IN THE IFU. FOUR SEPARATE INJECTIONS WERE USED AND THEY APPEARED VERY FAINT VIA FLOURO, AND IN ONE CASE, THE TANTALUM APPEARED TO BE BEADED. IT WAS REPORTED THAT THE OIL HAD BEEN PROTECTED FROM LIGHT AND THE MIXTURE WAS PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU). FORTUNATELY, THE PATIENT WAS SUCCESSFULLY TREATED WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7035073 ↗
• MalfunctionNov 15, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED BY A PHYSICIAN, WHEN INJECTING GLUE WITH TANTALUM AND APROX 1/2 CC TO 1CC OF OIL, THE GLUE WAS NOT VISIBLE AS INJECTING UNDER FLURO. PRODUCT INCLUDED TRUFILL NBCA 1 GRAM KIT (631500/ HA2573 X 2, 631500/ HF2890 X 1, AND UNKNOWN CATALOG/LOT X 1). THE EMBOLIZATION PROCEDURE WAS FOR TREATMENT OF VEIN OF GALIN ON A (B)(6) INFANT. THE PHYSICIAN, WHO HAS BEEN SUCCESSFULLY BEEN USING NBCA GLUE FOR MANY YEARS, ADDED THE ENTIRE PACKET OF TANTALUM POWDER WITH OIL (APPROX. ½ CC TO 1CC OF OIL) TO THE NBCA GLUE IN A GLASS BEAKER. THE RADIOPACITY OF THE MIXTURE WAS NOT CONFIRMED VIA FLOURO PRIOR TO INJECTION BY COMPARING THE GLUE TO A SIMILAR SYRINGE CONTAINING CONTRAST AS INSTRUCTED IN THE IFU. FOUR SEPARATE INJECTIONS WERE USED AND THEY APPEARED VERY FAINT VIA FLOURO, AND IN ONE CASE, THE TANTALUM APPEARED TO BE BEADED. IT WAS REPORTED THAT THE OIL HAD BEEN PROTECTED FROM LIGHT AND THE MIXTURE WAS PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU). FORTUNATELY, THE PATIENT WAS SUCCESSFULLY TREATED WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7035020 ↗

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-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
• 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;