DuraSealRecalls & reported problems across all models
Integra Lifesciences Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 3 models of DuraSeal by Integra Lifesciences Corporation in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2019 and Sep 29, 2026 — classified as 3 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Improper Chemical Reaction” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DuraSeal problems
Device problems
- Improper Chemical Reaction11
- Fluid/Blood Leak4
- Leak/Splash3
- Adverse Event Without Identified Device or Use Problem2
- Coagulation in Device or Device Ingredient2
- Device Ingredient or Reagent Problem1
- Failure to Seal1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Fistula1
- Nerve Damage1
- Post Operative Wound Infection1
DuraSeal models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DuraSeal® 202050Sealant, Dural20 reports
- DuraSeal® 202050Sealant, dural4 reports
- DuraSeal® 202010DSSealant, Dural1 report
Recent DuraSeal adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Improper Chemical Reaction
An authorized distributory reported that while DuraSeal Dural Sealant System (202050) was in contact with a patient, it could not turn into hydrogel formation. A replacement product was used to complete the procedure. There was no surgical delay or patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934497 ↗MalfunctionSep 25, 2026Improper Chemical Reaction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906204 ↗MalfunctionJul 27, 2026Improper Chemical Reaction
An authorized distributor reported that Netcare Akasia had an emergency craniotomy and they were called in for the case as there was an issue with the 5ML DuraSeal single kit per box US (202010DS) not drying after application. Upon inspection, the Duraseal had been applied with the Micromyst and even after 15 mins it still had not dried. Management was then informed immediately of the situation. The physician informed us that this can be a potential risk (infection) for the patient and future patients, so she will stop using the product until feedback is provided accordingly. There was increased surgery time of 15 minutes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50025150 ↗MalfunctionMar 9, 2026Improper Chemical Reaction
MalfunctionFeb 20, 2026Improper Chemical Reaction
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
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
MalfunctionJul 22, 2025Leak/Splash; Leak/Splash
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
Other Integra Lifesciences Corporation products
All Integra Lifesciences Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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