DuraSeal® 202050 (UDI 10381780000020)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10381780000020), received between Mar 8, 2019 and Mar 9, 2026 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Improper Chemical Reaction

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546659 ↗
• MalfunctionFeb 6, 2026Coagulation in Device or Device Ingredient

  A FACILITY REPORTED THAT FOLLOWING THE POWDER MIXING AND INSTALLATION OF DURASEAL DURAL SEALANT SYSTEM 5ML (202050), AN UNEVEN DISTRIBUTION OF THE SOLUTION WAS OBSERVED. COAGULATION IS SUSPECTED; HOWEVER, THE EXACT CAUSE REMAINS UNIDENTIFIED AS THE APPLICATION OCCURRED WITHIN 20 MINUTES OF PREPARATION. NO ERRORS WERE NOTED DURING THE MIXING PROCEDURE, AND DESPITE ALIGNING THE SYRINGE LEVELS, THE UNEVEN SPRAY PATTERN CONTINUED TO OCCUR. THERE WAS A DELAY OF 10 MINUTES; HOWEVER, NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279478 ↗
• InjuryOct 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23213151 ↗
• MalfunctionAug 14, 2025Improper Chemical Reaction; Improper Chemical Reaction

  A FACILITY REPORTED THAT DURASEAL DURAL SEALANT SYSTEM (202050) WAS IN CONTACT WITH A PATIENT DURING A TUMOR DURA PROCEDURE, AND WHEN INJECTING DILUENT SYRINGE (BLUE LABEL) INTO THE POWDER VIAL, THE POWDER WOULD NOT DISSOLVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805538 ↗
• MalfunctionJul 25, 2025Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612519 ↗
• MalfunctionJul 22, 2025Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572165 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 1 OF 2 AND LINKED TO MFG REPORT NUMBER: 1121308-2025-00022: A FACILITY REPORTED THAT A PATIENT DIAGNOSED WITH SUBDURAL HEMATOMA UNDERWENT SURGERY ON (B)(6) 2025. HOWEVER, IN THE FOLLOWING DAYS, HE DEVELOPED A FISTULA THAT REQUIRED REOPERATION. THE REOPERATION WAS PERFORMED TO TREAT THE AFOREMENTIONED COMPLICATION. THE SAME PRODUCT REFERENCES WERE USED IN THE SECOND SURGERY, AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Fistula

  MAUDE report 22385700 ↗
• MalfunctionJun 17, 2025Improper Chemical Reaction; Improper Chemical Reaction

  A FACILITY REPORTED THAT DURING A PROCEDURE (TUMOR DURA), THE DILUENT SYRINGE OF THE DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) BECAME JELLIED FORMATION. THERE WAS NO PATIENT INJURY AND SURGICAL DELAY IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235248 ↗
• MalfunctionJun 11, 2025Failure to Seal; Failure to Seal

  A FACILITY REPORTED THAT DURING A SURGICAL PROCEDURE TO RESECTION A SKULL BASE TUMOR, THE DURASEAL DURAL SEALANT SYSTEM 5ML (202050) WAS PREPARED AS DIRECTED, AND WHEN APPLIED TO THE PATIENT, IT DID NOT SEAL. THERE WAS A 15 MINUTE DELAY IN SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185326 ↗
• MalfunctionMay 22, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  A FACILITY REPORTED THAT DURING A PROCEDURE, AND WHILE DURASEAL SEALANT (202050) WAS IN CONTACT WITH A PATIENT, "INJECTING DILUENT SYRINGE <BLUE LABEL> INTO POWDER VIAL AND THE POWDER WOULDN'T DISSOLVE." THERE WAS NO PATIENT INJURY AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070670 ↗
• MalfunctionMay 15, 2025Improper Chemical Reaction; Improper Chemical Reaction

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027158 ↗
• MalfunctionMay 8, 2025Improper Chemical Reaction; Improper Chemical Reaction

  A FACILITY REPORTED THAT DURING "LEFT PARIETAL METASTATIC LESION, POSTOPERATIVE RESECTION OF LEFT PARIETAL LESION BY NEURO-NAVIGATION-GUIDED CRANIOTOMY" PROCEDURE, A PATCH WAS PLACED AND WHEN DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) WAS APPLIED IT CAME OUT LIQUID AND DID NOT ADHERE. ANOTHER PRODUCT FROM ANOTHER COMMERCIAL BRAND WAS USED TO COMPLETE THE SURGICAL PROCEDURE. THERE WAS A DELAY IN SURGERY, HOWEVER, NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS DISCHARGED STABLE WITH RECOMMENDATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986618 ↗
• MalfunctionMay 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY REPORTED THAT DURING "POSTERIOR LUMBAR INTERBODY FUSION" PROCEDURE, THE DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) SOLUTION LEAKED OUT AND COULD NOT BE USED WHILE BEING INJECTED INTO THE POWDER VIAL. THE PROBLEM OCCURRED DURING THE PROCESS OF DILUTING THE POWDER AND SOLUTION AND DID NOT COME IN CONTACT WITH THE PATIENT. SURGERY WAS DELAYED FOR THE MOMENT, BUT IT WAS SUCCESSFULLY COMPLETED DUE TO THE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942454 ↗
• MalfunctionMay 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY REPORTED THAT THE DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) SOLUTION LEAKED OUT AND COULD NOT BE USED WHILE BEING INJECTED INTO THE POWDER VIAL. THE PROBLEM OCCURRED DURING THE PROCESS OF DILUTING THE POWDER AND SOLUTION AND WAS NOT IN CONTACT WITH A PATIENT. SURGERY WAS DELAYED FOR THE MOMENT, BUT IT WAS SUCCESSFULLY COMPLETED DUE TO THE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941864 ↗
• MalfunctionApr 28, 2025Improper Chemical Reaction; Improper Chemical Reaction

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918562 ↗
• MalfunctionJan 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY REPORTED THAT WHEN THEY PRESSED THE THREADED FITTING OF THE POWDER BOTTLE AND CONNECTED IT TO THE BLUE SYRINGE, LIQUID LEAKAGE OCCURRED WHEN INJECTING THE BLUE SOLUTION INTO THE POWDER BOTTLE OF THE DURASEAL DURAL SEALANT SYSTEM (202050). THERE WAS A DELAY OF 10 MINUTES; HOWEVER, NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169799 ↗
• MalfunctionJan 16, 2025Improper Chemical Reaction; Improper Chemical Reaction

  A FACILITY REPORTED THAT THE NURSE MIXED THE LIQUID AND POWDER FROM THE DURASEAL DURAL SEALANT SYSTEM (202050) AND DELIVERED IT TO THE DOCTOR, BUT THE SOLUTION DID NOT SPRAY PROPERLY AND DID NOT HARDEN, SO IT WAS EVENTUALLY DISCARDED, AND A NEW PRODUCT WAS USED. AFTER COMBINING ALL THE INGREDIENTS, IT WAS APPLIED TO THE AFFECTED AREA, BUT IT DID NOT HARDEN INTO A GEL AND REMAINED IN A LIQUID STATE. THEY REPORTED THAT WHEN PREPARING THE BLUE PRECURSOR, THEY PRESSED DOWN FIRMLY UNTIL THE RED LINE ON THE POWDER BOTTLE WAS NO LONGER VISIBLE AND USED A DILUTING SYRINGE (BLUE) TO DILUTE THE SOLUTION IN THE VIAL, AND THEN PLACED THE SOLUTION BACK INTO THE SYRINGE. HOWEVER, THE AMOUNT OF SOLUTION COLLECTED WAS LESS THAN THE EXPECTED 2.5 ML AND ONLY ABOUT 1.2 ML WAS OBTAINED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE AND THERE WAS MINIMAL DELAY OF 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169429 ↗
• MalfunctionFeb 12, 2024Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18692364 ↗
• MalfunctionJan 19, 2024Leak/Splash; Leak/Splash

  A DISTRIBUTOR REPORTED THAT DURING AN UNSPECIFIED SURGERY, DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) WAS RETRIEVED FROM COLD SHELTER FOR USE AT THE COMPLETION OF THE SURGERY. THE SURGICAL CONSULTANT WHO ATTENDED THE SURGERY REPORTED THAT WHEN HE PUT THE SYRINGE IN THE VIAL, IT BEGAN TO SPILL OVER THE SIDES AND THE PRODUCT COULD NOT BE USED - "IT WAS LIKE IT DIDN'T FIT RIGHT." IT WAS NECESSARY TO OPEN A NEW ONE SINCE IT WAS REQUIRED FOR THE SURGERY. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545115 ↗
• InjuryMar 8, 2019Therapeutic or Diagnostic Output Failure

  PRODUCT PLACED DURING SPINE SURGERY PROCEDURE. UPON FOLLOW UP APPOINTMENT PATIENT HAD IMAGING STUDIES WHICH DEMONSTRATED DURASEAL PRODUCT HAD EXPANDED AND CAUSED CAUDA EQUINA.

  Patient problems: Nerve Damage

  MAUDE report 8403132 ↗