CaminoRecalls & reported problems across all models
Integra Lifesciences (Ireland) Limited · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Camino by Integra Lifesciences (Ireland) Limited in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Nov 12, 2017 and Nov 4, 2022 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Device Operational Issue” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Camino problems
Device problems
- Device Operational Issue12
- Unable to Obtain Readings5
- Incorrect, Inadequate or Imprecise Result or Readings4
- Invalid Sensing4
- Device Displays Incorrect Message2
- Calibration Problem1
- Display or Visual Feedback Problem1
- Failure to Run on Battery1
Patient problems
- No Known Impact Or Consequence To Patient22
- No Consequences Or Impact To Patient8
- No Information3
- No Clinical Signs, Symptoms or Conditions1
Camino models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Camino® CAM02DEVICE, MONITORING, INTRACRANIAL PRESSURE25 reports
- Camino® CAMCABLDEVICE, MONITORING, INTRACRANIAL PRESSURE7 reports
Recent Camino adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem
PART CAMCABL : TEMP ERROR. CUSTOMER ORIGINALLY MADE REPORT ON THEIR CAM02 UNIT, SN: (B)(6), STATING THE TEMPERATURE READINGS ARE NOT CORRECT. CUSTOMER WAS RECOMMENDED TO REPLACE THE CAMCABL, WHICH RESOLVED THE ISSUE. CUSTOMER WAS ASKED TO RETURN THE COMPLAINT FORM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15734373 ↗MalfunctionDec 3, 2019Failure to Run on Battery; Failure to Run on Battery
MONITOR CURRENTLY PLUGGED IN, HOWEVER EXTERNAL BATTERY INDICATOR SHOWS AS NOT CHARGING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9402902 ↗MalfunctionNov 26, 2019Unable to Obtain Readings; Unable to Obtain Readings
CAM02 NO LONGER READS CORRECTLY AFTER PATIENT WAS TRANSFERRED TO THEIR PROCEDURE. CUSTOMER CONFIRMS CATHETER WAS ZEROED PRIOR TO PROCEDURE, AND CAM02 MONITOR AND CAMCABLS WERE SWAPPED OUT, ISOLATING CATHETER FAILURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9376163 ↗MalfunctionNov 26, 2019Output Problem; Output Problem
CAM02 UNIT IS EXPERIENCING CATHETER FAILURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9376141 ↗MalfunctionOct 29, 2019No Device Output; No Device Output
PATIENT CONNECTED TO CATHETER, THEN TO MONITOR WHICH DID NOT SHOW RESPONSE. MONITOR REPLACED WITH A BACKUP UNIT WHICH RESPONDED AS EXPECTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9252776 ↗MalfunctionApr 24, 2019Unable to Obtain Readings; Unable to Obtain Readings
MEDICAL INTERVENTION NEEDED AFTER MONITOR DID NOT DISPLAY CORRECT VALUES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8544762 ↗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 8533483 ↗MalfunctionApr 19, 2019Unable to Obtain Readings; Unable to Obtain Readings
CAM02 UNIT DISPLAYS ERROR CODE WHICH CAUSED DELAY IN SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8533480 ↗MalfunctionAug 27, 2018Power Problem; Power Problem
THE FOLLOWING WAS REPORTED BY A USER FACILITY: (B)(4), WAS ON A PATIENT (B)(6) 2018 AND AT APPROX 5PM, A PROBLEM WAS REPORTED: MONITOR SHUT OFF COMPLETELY AND WAS UNABLE TO BE RESTARTED. WHEN ATTEMPTED TO TURN IT BACK ON SYSTEM SAID IT NEEDED TO BE SERVICED. NEURO SURGERY CALLED AND BOLT HAD TO BE PULLED OUT AND REPLACED. ICP WAS UNABLE TO BE MONITORED FOR 2 HOURS DUE TO MALFUNCTION ON A PATIENT WITH HIGH ICP'S THAT WE WERE ACTIVELY TREATING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7820514 ↗MalfunctionAug 23, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE FOLLOWING WAS REPORTED BY THE SITE/ USER FACILITY REGIONAL SALES DIRECTOR: "THE SITE IS EXPERIENCING LARGE SWINGS IN READINGS TO THE NEGATIVE SIDE AFTER THE CATHETER HAS BEEN ZERO'D AND PLACED. THIS IS OCCURRING POSSIBLY 24-48 HOURS INTO USE. THE CUSTOMER HAS BEEN ABLE TO SWAP MONITORS TO GET A POSITIVE READING". ADDITIONAL INFORMATION: MONITOR DATA LOGS SHOWED MULTIPLE CODES/ ERRORS. THE FACILITY LEFT CABLES AND CATHETER CONNECTED TO PATIENT, SWITCHED MONITOR, AND ISSUE RESOLVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7810126 ↗MalfunctionJun 27, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
CAM02 (B)(4) NOT READING CORRECTLY. ADDITIONAL INFORMATION RECEIVED VIA PHONE CALL ON 18 JUNE 2018: DEVICE WAS ATTACHED TO PATIENT AT THE TIME OF THE INCIDENT. NO INJURY TO THE PATIENT; DEVICE WAS CHANGED OUT; THERE WAS SOME DELAY IN SURGERY, BUT NOT A SIGNIFICANT ONE. INCIDENT DATE IS UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7641888 ↗MalfunctionJun 26, 2018Device Operational Issue; Device Operational Issue
THE 110 4 B OLM PARENCHYMAL CATHETER CONNECTED TO CAMINO MONITOR SERIAL NUMBER (B)(4), STATUS BAR INITIALLY READ "CATHETER IS INITIALIZING", THEN CHANGED TO "CATHETER FAILURE". SURGEON REPLACE INITIAL 110 4 B CATHETER WITH ANOTHER 110 4 B CATHETER, AND RECEIVED THE SAME READINGS - INITIALLY READ "CATHETER IS INITIALIZING", THEN CHANGED TO "CATHETER FAILURE". CAMINO MONITOR SERIAL NUMBER (B)(4) WAS SWITCHED OUT WITH DIFFERENT MONITOR, WITH SECOND CATHETER, AND RECEIVED NO ERROR MESSAGES. CATHETER PERFORMED NORMALLY AFTER SWITCHING OUT MONITOR. NO ALLEGED DEATH/ INJURY. PATIENT INFORMATION: NOT AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7638161 ↗MalfunctionJun 18, 2018Device Operational Issue; Device Operational Issue
DURING THE PROCEDURE, THERE WAS SUDDENLY NO DATA SHOWED ON THE CAMINO MONITOR. AFTER CHANGED WITH A NEW CAMCABL, THE PROBLEM FIXED. SO THE PROBLEM WAS WITH THE FORMER CAMCABL. PATIENT INJURY/ DEATH ALLEGED: NO . REVISION/MEDICAL INTERVENTION REQUIRED: NO. PATIENT PREPPED FOR SURGERY: YES . DELAY IN SURGERY DUE TO LATE RECEIPT OF PRODUCT:: UNK. DELAY IN SURGERY DUE TO PRODUCT PROBLEM: YES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7611424 ↗MalfunctionJun 18, 2018Device Operational Issue; Device Operational Issue
DURING THE PROCEDURE, THERE WAS SUDDENLY NO DATA SHOWED ON THE CAMINO MONITOR. AFTER CHANGED WITH A NEW CAMCABL, THE PROBLEM FIXED. SO THE PROBLEM WAS WITH THE FORMER CAMCABL. PATIENT INJURY/ DEATH ALLEGED: NO. PATIENT PREPPED FOR SURGERY: YES. DELAY IN SURGERY DUE TO LATE RECEIPT OF PRODUCT: UNK. DELAY IN SURGERY DUE TO PRODUCT PROBLEM: YES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7609962 ↗MalfunctionJun 12, 2018Invalid Sensing; Invalid Sensing
MONITOR IS SHOWING INCORRECT READING (HALF OF CAMINO OUTPUT IS BEING DISPLAYED). DELAY IN SURGERY: UNKNOWN WAS THERE ANY PATIENT INJURY/ DEATH ALLEGED: NO ANY REVISIONS/MEDICAL INTERVENTIONS REQUIRED: MONITOR COULD NOT BE CONNECTED TO EPIC (EMR) / LOCAL MONITOR AS DATA INCORRECT - VALUES HAD TO BE MANUALLY CHARTED WAS THE PATIENT (S) PREPPED FOR SURGERY: NO ANY DELAY IN SURGERY DUE TO LATE RECEIPT OF PRODUCT: NO ANY DELAY IN SURGERY DUE TO PRODUCT PROBLEM(S): NO.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7593154 ↗
Other Integra Lifesciences (Ireland) Limited products
All Integra Lifesciences (Ireland) Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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