CAMINO® 110-4B (REF 1104B)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382830047494), received between Apr 26, 2021 and May 17, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K102875); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2026Break

  NT821731C - CAMINO BOLT PLACEMENT RESULTED IN PIECES BROKEN/MALFUNCTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196268 ↗
• MalfunctionDec 3, 2024Display or Visual Feedback Problem; Temperature Problem; Display or Visual Feedback Problem; Temperature Problem

  PART1104B -OLM INTRACRANIAL PRESSURE MONITORING KIT - PATIENT ON CAMINO ICP MONITOR. PATIENT WAS PLACED FLAT FOR CARE, CAMINO WITH BOLT INTACT. PATIENT HAD BEEN FOR ICP (INCREASED INTRACRANIAL PRESSURE) RANGE 3-5 JUMPED TO 18-19, NO CHANGE IN PATIENTS' ASSESSMENT. HOB (HEAD OF BED) ELEVATED WAVE CONSISTENT, THEN FLATTED. RESIDENT CALLED NATUS 24/7 CLINICAL SUPPORT. DURING TROUBLESHOOTING THE SCREEN PRESENTED TEMPERATURE NUMBERS - [REDACTED NAME] DOES NOT USE TEMPERATURE INTEGRATION. THE SCREEN THEN FLASHED OUT OF THE TEMPERATURE RANGE. DUE TO THE CONCERN OF THE SCREEN AND INFLATED NUMBERS -BOLT REMOVED. BOTH THE CAMINO AND BOLT ARE BEING SENT TO THE COMPANY FOR FURTHER INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831436 ↗
• MalfunctionNov 21, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  PART1104B -OLM INTRACRANIAL PRESSURE MONITORING KIT - PATIENT HAD SINGLE LUMEN INTRACRANIAL BOLT INSERTED OVERNIGHT, REQUIRED USE OF CAMINO MONITOR FOR ICP (INTRACRANIAL PRESSURE) READINGS. WHEN CATHETER INSERTED AND CONNECTED TO CAMINO, "CATHETER ERROR" MESSAGE WAS RECEIVED. STAFF ATTEMPTED TO USE SECOND CAMINO MONITOR, RECEIVED SAME ERROR MESSAGE "CATHETER FAILURE". PATIENT REQUIRED SURGERY AND WAS SENT TO THE OR WITH THE CATHETER IN PLACE, SECONDARY PORTION OF MONITORING DEVICE WAS KEPT, CATHETER WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187372 ↗
• MalfunctionNov 10, 2023Failure to Zero; Failure to Zero

  PART1104B -OLM INTRACRANIAL PRESSURE MONITORING KIT - DURING DOCTOR'S ROBOTIC SEEG (STEREOELECTROENCEPHALOGRAPHY) CASE, HE WANTED TO USE A NATUS CAMINO INTRACRANIAL PRESSURE MONITOR. WHEN HE WENT TO ZERO IT OUT BEFORE USE, IT REMAINED AT A SETTING OF 300 AND WOULD NOT MOVE. HE USED A DIFFERENT ONE INSTEAD. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18109053 ↗
• MalfunctionAug 15, 2023Inaccurate Information; Imprecise or Erratic Results; Inaccurate Information; Imprecise or Erratic Results

  PART1104B -OLM INTRACRANIAL PRESSURE MONITORING KIT -ICP READING > 300, CATHETER WOULD NOT READ AN ACCURATE ICP. IT WAS CONFIRMED THE PART WAS IN CONTACT WITH THE PATIENT, HOWEVER THERE WAS NO DELAY IN SURGERY OR ADDITIONAL MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547558 ↗
• MalfunctionAug 15, 2023Material Frayed; Material Frayed

  PART 1104B -OLM INTRACRANIAL PRESSURE MONITORING KIT -CATHETER SHREDDED AT THE WIRE. IT WAS CONFIRMED THE PART WAS IN CONTACT WITH THE PATIENT, HOWEVER THERE WAS NO DELAY IN SURGERY OR ADDITIONAL MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547557 ↗
• MalfunctionSep 13, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  PART1104B -OLM INTRACRANIAL PRESSURE MONITORING KIT - LOWER-THAN-EXPECTED ICP READINGS. THE CATHETER WAS ZEROED AND PLACED IN THE PATIENT ON (B)(6) 2022. ICP READINGS FELL INCONSISTENT OVERNIGHT. NEUROSURGEON IS NOT NEW TO THE PRODUCT. CATHETER'S RED DOT DEPTH INDICATOR DID NOT FLUCTUATE WHEN THE CATHETER OR CABLE WAS MOVED. ICP VALUES DID MOVE WHEN PATIENT WAS LAID FLAT AND WHEN HEAD OF BED WAS RE-POSITIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414196 ↗
• MalfunctionApr 26, 2021Display or Visual Feedback Problem

  CUSTOMER STATES THEIR SYSTEM SHOWS AN ERROR MESSAGE WHEN IMPLANTING MPIC. RESOLUTION WAS FOUND AFTER SWAPPING MPIC. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722605 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102875. One submission often covers many models, so check the product and lot details in each record.

• Z-1815-2015 · May 27, 2015 · Terminated
  Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transduce
• Z-2072-2014 · Jul 9, 2014 · Terminated
  Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
• Z-0117-2014 · Sep 10, 2013 · Terminated
  Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully p