Hermetic™ INS8330Recalls & reported problems
Integra Lifesciences Corporation · Hermetic™ Lumbar Catheter Open Tip · Class 2 · Implant
All models of Hermetic (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780026211), received between Sep 21, 2023 and Jan 12, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation2
- Fluid/Blood Leak1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2024Material Separation; Material Separation
THIS REPORT IS FOR THE 2ND OF 2 TIPS USED ON THE SAME PATIENT AND LINKED TO MFG REPORT NUMBER 2648988-2024-00002: A FACILITY REPORTED THAT THE TIP OF THE HERMETIC LUMBAR CATHETER, OPEN TIP (INS8330) WAS RETAINED AND AND BROKE INSIDE A PATIENT. THERE WAS INCREASED SURGERY TIME OF 15 MINUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18505304 ↗MalfunctionJan 12, 2024Material Separation; Material Separation
MalfunctionSep 21, 2023Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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