Duraseal 206520Recalls & reported problems
Covidien LP · Exact Spine Sealant System, · Class 3 · Implant
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 20884521056388), received between Dec 6, 2024 and Dec 6, 2024 — 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.
MalfunctionDec 6, 2024Improper Chemical Reaction; Improper Chemical Reaction
AN AUTHORIZED DISTRIBUTOR REPORTED THAT DURING THE PREPARATION PROCESS OF DURASEAL EXACT SPINE SEALANT SYSTEM (206520), A LIGHT BLUE TONE WAS ACQUIRED WHEN INTRODUCING THE LIQUID FROM THE BLUE SYRINGE INTO THE AMPULE CONTAINING THE POWDER TO BE RECONSTITUTED. IT WAS OBSERVED THAT THE TEXTURE OF THE RESULTING LIQUID AFTER MIXING THE TWO SYRINGES WAS WATERY AND TRANSPARENT. THE PRODUCT DID NOT COME IN CONTACT WITH THE PATIENT, BUT THE PATIENT WAS PREPPED FOR SURGERY AND PRODUCT ISSUE RESULTED IN SURGICAL DELAY OF APPROXIMATELY 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20864198 ↗
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® 202010DSIntegra Lifesciences Corporation · 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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