Hermetic™ INS4000Recalls & reported problems
Integra Lifesciences Corporation · Hermetic™ Ventricular Small Catheter Set · Class 2 · Implant
All models of Hermetic (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780071068), received between Oct 3, 2024 and Oct 3, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2024Material Fragmentation; Material Fragmentation
MEDSUN REPORT# (B)(4) WAS RECEIVED WITH THE FOLLOWING INFORMATION: "WHILE THE NEUROSURGEON WAS REMOVING THE PATIENT'S EVD CATHETER, PART OF THE CATHETER BROKE OFF AND WAS RETAINED INTERNALLY. THE BROKEN PIECE WAS NOT VISIBLE, AND THE NEUROSURGEON SUTURED THE INCISION SITE. A CT SCAN WAS ORDERED AND CONFIRMED THE RETAINED CATHETER TIP SIZE AND LOCATION. MANUFACTURER RESPONSE FOR HERMETIC VENTRICULAR SMALL CATHETER SET, HERMETIC VENTRICULAR SMALL CATHETER SET (PER SITE REPORTER) THE CATHETER IS THE ONE USED ON THE PATIENT, IT IS WHITE IN COLOR AND IS NOT IMPREGNATED. THE SIZE IS 1.3 DIAMETERS. HOWEVER, [(B)(6)] (REP) CAN¿T SAY FOR CERTAIN IF ONE IS FIRMER THAN THE OTHER. HE STATED THAT THERE HAVE NOT BEEN ANY CHANGES TO THE POLYURETHANE MATERIAL CATHETER, AND THAT THERE HAVE NOT BEEN ANY REPORTS OF THEM BREAKING. (B)(6)] HAD SOME ADDITIONAL QUESTIONS REGARDING THE DRILL SIZE USE FOR INSERTION AND THE PHYSICIAN¿S TECHNIQUE. EDUCATOR INFORMED HIM THAT SHE WOULD FORWARD THESE QUESTIONS TO THE EXECUTIVE MEDICAL TEAM. [(B)(6)] CAN BE REACHED AT [(B)(6)]. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? EVD CATHETER REMOVAL". SUBSEQUENTLY WE RECEIVED ADDITIONAL INFORMATION FROM CUSTOMER IN RESPON
Patient problems: Foreign Body In Patient
MAUDE report 20363495 ↗
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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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