CAMINO® 110-4B (UDI 10381780023623)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10381780023623), received between Apr 19, 2018 and May 26, 2021 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Output Problem” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2021Degraded

  OLM INTRACRANIAL PRESSURE MONITORING KIT - CLIENT CLAIMS THAT THE BUTTON WAS LOCKED, APPARENTLY IT IS RUSTY. DELAY IN PROCEDURE, RESOLVED BY CATHETER CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885351 ↗
• MalfunctionDec 23, 2019Output Problem; Output Problem

  CAM02 MONITOR IS UNABLE TO DETECT 1104B CATHETER AFTER TRANSFERRING THE PATIENT TO THE OR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9512590 ↗
• MalfunctionDec 3, 2019Output Problem; Output Problem

  CATHETER HAS FAILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9402914 ↗
• MalfunctionDec 3, 2019Output Problem; Output Problem

  CATHETER HAS FAILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9402892 ↗
• MalfunctionSep 4, 2019Output Problem; Output Problem

  CATHETER GAVE HIGH READINGS COMPARED TO EVD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962499 ↗
• MalfunctionApr 24, 2019Premature Separation; Premature Separation

  OUTER HUB DID NOT PROPERLY SECURE TO THE PROBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8544759 ↗
• MalfunctionApr 19, 2019Unable to Obtain Readings; Unable to Obtain Readings

  CATHETER SHOWS TO HAVE FAILED ON MONITOR AFTER INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8533478 ↗
• MalfunctionApr 4, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MONITOR DISPLAYING INACCURATE WAVEFORMS WITHIN 24 HOURS OF PLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8484402 ↗
• InjuryApr 4, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CATHETER SHOWS AS FAILED TWO DAYS AFTER PLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8484396 ↗
• InjuryMar 25, 2019Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings; Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings

  DURING SURGERY, INITIAL CATHETER FAILED SHOWING ERROR WITH WAVEFORMS ON MONITOR. INITIAL CATHETER WAS REMOVED AND TWO SUBSEQUENT CATHETERS WERE BROUGHT IN FOR REPLACEMENT, BUT NEITHER BACKUP CATHETERS COULD PASS MONITOR INITIALIZATION, CAUSING FURTHER DELAY IN SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8447860 ↗
• MalfunctionAug 15, 2018False Negative Result; False Negative Result

  AS REPORTED BY THE USER FACILITY, ON 3 DIFFERENT OCCASIONS, ON 3 DIFFERENT PATIENTS, THE 110 4 B CATHETER WAS CONNECTED TO MONITOR - WAS READING A NORMAL ICP (0 TO 15 MMHG), THEN DROPPED TO A NEGATIVE NUMBER. ONE OCCURRED OUT OF BOX, THE OTHER OCCURRED A DAY LATER. DATE OF INCIDENT: SOMETIME DURING WEEK OF (B)(6), CLIENT UNSURE OF EXACT DATES. DEVICE IN CONTACT WITH PATIENT: 110 4 B, OLM PARENCHYMAL CATHETER. PATIENT INJURY/ DEATH ALLEGED: NONE. REVISION/MEDICAL INTERVENTION REQUIRED: NONE. PATIENT PREPPED FOR SURGERY: NOT APPLICABLE. PATIENT INFORMATION: DO NOT HAVE. DELAY IN SURGERY DUE TO LATE RECEIPT OF PRODUCT: NOT APPLICABLE. DELAY IN SURGERY DUE TO PRODUCT PROBLEM: NOT APPLICABLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2018: "WE ARE HAPPY TO PROVIDE WHATEVER ADDITIONAL INFO IS NEEDED. WE RECENTLY HAD A VERY CONCERNING ISSUE IN WHICH WE HAD A PATIENT WHO HAD A CAMINO PLACED AND THEN REPLACED DUE TO NEGATIVE NUMBERS DURING THE DAY. IT WAS NEGATIVE AGAIN AFTER SHIFT CHANGE. THE PATIENT HAD TO BE RESCANNED TO SEE IF THERE WERE CHANGES. HIS NEURO EXAM WAS UNCHANGED BUT HAD A VERY POOR EXAM. A SECOND CAMINO WAS PLACED AND THE READ WAS 54. - FIRST READING NEGATIVE 7. T

  Patient problems: Test Result

  MAUDE report 7785846 ↗
• MalfunctionAug 13, 2018Device Sensing Problem; Device Sensing Problem

  THE FOLLOWING WAS REPORTED BY A USER FACILITY IN (B)(6): FOR 2 PATIENTS THE CAMINO ICP PROBES SHOWED SIGNIFICANT DEVIATIONS IN THE VALUES COMPARED TO ALREADY EXISTING MEASUREMENTS (EVD). MEDICAL DEVICE FAILURE: YES. PRODUCT IN CONTACT WITH PATIENT? YES. IS PATIENT INJURY OR DEATH ALLEGED? NO. DID THE EVENT LEAD TO SIGNIFICANT INCREASE IN SURGERY TIME? NO. IS PRODUCT BEING RETURNED? YES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. CROSS REFERENCE MDR 2023988-2018-00043.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7779083 ↗
• MalfunctionAug 13, 2018Device Sensing Problem; Device Sensing Problem

  THE FOLLOWING WAS REPORTED BY A USER FACILITY IN (B)(6): FOR 2 PATIENTS THE CAMINO ICP PROBES SHOWED SIGNIFICANT DEVIATIONS IN THE VALUES COMPARED TO ALREADY EXISTING MEASUREMENTS (EVD). MEDICAL DEVICE FAILURE: YES. PRODUCT IN CONTACT WITH PATIENT? : YES. IS PATIENT INJURY OR DEATH ALLEGED?: NO. DID THE EVENT LEAD TO SIGNIFICANT INCREASE IN SURGERY TIME? : NO. IS PRODUCT BEING RETURNED?: YES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7778446 ↗
• MalfunctionAug 2, 2018Pressure Problem; Pressure Problem

  THE FOLLOWING WAS REPORTED BY A USER FACILITY IN (B)(4): "LOSS OF THE PRESSURE SIGNAL INTRODUCTION OF THE CATHETER IN THE TREPAN. CHANGED THE CATHETER. CLINICAL CONSEQUENCES FOUND? NOTHING TO REPORT." NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7744743 ↗
• MalfunctionApr 19, 2018Unable to Obtain Readings; Device Issue; Unable to Obtain Readings; Device Issue

  THE FOLLOWING WAS REPORTED BY A FOREIGN USER FACILITY: "THE HOSPITAL INFORMED THE CATHETER STOPPED THE MEASUREMENT DURING THE USE" ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7444531 ↗