DuraSeal® 202010DSRecalls & reported problems
Integra Lifesciences Corporation · DuraSeal® Dural Sealant System Polymer Kit · Class 3 · Implant
All models of DuraSeal (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780000013), received between Jul 27, 2026 and Jul 27, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper Chemical Reaction” (1 report).
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 Reaction1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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® 202050Integra Lifesciences Corporation · 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 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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