Skip to content

Integra® 990010Recalls & reported problems

Integra Neurosciences Implant (France) · The Tunneler is a single-use instrument consisting of a stainless steel cannula with removable handle, plastic line with bullet-shaped end and barbed end, and sheath. The tunneler (65 cm) is used to make a subcutaneous tunnel between two incisions for procedures such as the subcutaneous insertion of the peritoneal drainage catheter of a hydrocephalus shunt. The barbed end is intended to be connected to a 0.8 to 1.4 mm internal diameter catheter. · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780034414), received between Mar 3, 2022 and Mar 25, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Difficult to Remove1
  • Mechanical Jam1

Patient problems

  • Confusion/ Disorientation1
  • Keratitis1
  • No Clinical Signs, Symptoms or Conditions1
  • Paresis1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 25, 2022Mechanical Jam; Mechanical Jam

    A FACILITY REPORTED THAT DURING VENTRICULO-PERITONEAL SHUNT PLACEMENT, THE SHUNT TUNNELER (990010) HANDLE WAS STUCK. THE SURGEON HAD TO BREAK THE PLASTIC HANDLE TO CONTINUE THE PROCEDURE. THERE WAS RISK OF INJURY FOR THE PATIENT AND FOR THE SURGEON DURING BREAKAGE/DISASSEMBLY OF THE HANDLE. FACILITY ALSO STATED THERE WAS A RISK OF PNEUMOTHORAX DUE TO THE POSSIBLE 2ND IMPLANTATION OF TUNNELER. ADDITIONAL INFORMATION RECEIVED INDICATES THERE WAS INCREASED SURGERY TIME OF 15 MINUTES AND THAT THE PATIENT WAS HOSPITALIZED IN NEUROSURGERY DEPARTMENT WITH FLUCTUATING TEMPORAL-SPATIAL DISORIENTATION AND TETRAPARESIS DURING REHABILITATION. HE ALSO HAS LEFT EYE CORNEAL ABSCESS DUE TO EXPOSURE KERATITIS. THE 2ND IMPLANTATION OF TUNNELER WAS AVOIDED BY THE SURGEON.

    Patient problems: Confusion/ Disorientation; Keratitis; Paresis

    MAUDE report 13902051 ↗
  • MalfunctionMar 3, 2022Difficult to Remove; Difficult to Remove

    A FACILITY REPORTED THAT DURING VENTRICULO PERITONEAL SHUNT SURGERY, THE BLUE HANDLE OF THE SHUNT TUNNELER (990010) WHICH IS TO BE EXPLANTED FROM THE VALVE GUIDE WAS STUCK. THE DEVICE WAS ALREADY INTRODUCED UNDER THE PATIENT'S SKIN FROM HEAD TO ABDOMEN WHEN THE ISSUE HAPPENED. THE SURGEON HAD TO APPLY FORCE TO TAKE IT OUT WHICH TWISTED THE TUNNELER. THEY UNTWISTED THE SYSTEM AFTER, THE TUNNELER WAS TORN, AND THERE WAS RISK OF INJURY FOR PATIENT AND SURGEON. NO INJURY WAS REPORTED. THERE WAS INCREASED SURGERY TIME OF 15 MINUTES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13662841 ↗

Other Instrument, shunt system implantation devices

All Instrument, shunt system implantation devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.