DuraSeal® 202050 (UDI 10381780537175)Recalls & reported problems
Integra Lifesciences Corporation · DuraSeal® Dural Sealant System Polymer Kit 5 mL · Class 3 · Implant
All models of DuraSeal (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780537175), received between Mar 7, 2025 and Sep 29, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Improper Chemical Reaction” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Improper Chemical Reaction3
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, 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 ↗MalfunctionFeb 20, 2026Improper Chemical Reaction
MalfunctionMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
Other Sealant, dural devices
- DuraSeal® 202050Integra Lifesciences Corporation · Sealant, Dural20 reports
- DuraSeal Exact Spinal Sealant System 206520Integra Lifesciences Corporation · Sealant, Dural15 reports
- CraniSeal Dural Sealant CS-2055Pramand LLC · Sealant, Dural4 reports
- DuraSeal® Exact 206520Integra Lifesciences Corporation · Sealant, dural2 reports
- Adherus NUS-106Stryker Corporation · Sealant, Dural2 reports
- SpineSeal Spine Sealant SS-2055Pramand LLC · Sealant, Dural1 report
- DuraSeal® 202010DSIntegra Lifesciences Corporation · Sealant, Dural1 report
- Duraseal 206520Covidien LP · Sealant, dural1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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