Camino® CAMCABLRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10381780039556), received between Nov 12, 2017 and Nov 4, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (6 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 7 most recent of 7 reports, 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 CUSTOMER ORIGINALLY MADE REPORT ON THEIR CAM02 UNIT, SN: (B)(6), STATING THE TEMPERATURE READINGS ARE NOT CORRECT.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 ↗
• 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 ↗
• MalfunctionDec 27, 2017Device Operational Issue; Device Operational Issue

  SEE MDR 2023988-2017-00503 FOR ORIGINAL COMPLAINT MADE FOR THE MODEL CAM02. THE ORIGINAL COMPLAINT MADE FOR THAT DEVICE IS COPIED HERE: "1104 HM WAS PLACED AND INITIAL READING CORRELATED. WHEN SURGEON ROUNDED THIS MORNING ICP READING WAS OFF BY 20. SURGEON DISCONTINUED USE OF THE CAM02 AND CATHETER MONITORING AND RESUMED WITH A TRANSDUCER AND MANUAL ICP MONITORING." ALSO COPIED FROM 2023988-2017-00503 EVENT DESCRIPTION: "THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. THE CUSTOMER REPORTED NO REVISION OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT." DURING THE INVESTIGATION FOR (B)(4), AND AS DESCRIBED IN THE INVESTIGATION RESULTS IN FOLLOW-UP 1 FOR MDR 2023988-2017-00503, THE CAMCABL RETURNED WITH THE CAM02 FOR INVESTIGATION WAS FOUND TO BE DEFECTIVE AND THUS, THIS REPORT WAS INITIATED FOR THE CAMCABL. FROM THE "MINIMUM COMPLAINT INFORMATION FORM" INITIATED WHEN THE DEFECTIVE CAMCABL WAS DISCOVERED DATED (B)(6) 2017: "THIS COMPLAINT IS RELATED TO THE CAM02 MONITOR SERIAL (B)(4) THAT HAS COMPLAINT- EVALUATION REVEALED "THE MONITOR WAS TESTED GOOD- NO FAULT FOUND". HOWEVER, THE CAMCABL SERIAL (B)(4) WAS REJECTED DUE TO INTERMITTENT ICP READINGS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148657 ↗
• MalfunctionDec 15, 2017Device Operational Issue; Device Operational Issue

  FROM E-MAIL FORWARDED BY INTEGRA ON 08 NOV 2017: "CATHETER ERROR WHEN PLUGGED INTO CAMINO MONITOR. NEED TO HAVE CABLE REPLACED. NO PATIENT INJURY, FOUND DURING SURGERY, HOWEVER, NO DELAY." FOLLOW-UP E-MAIL SENT 13 DEC 2017 FOR MORE INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7121664 ↗
• MalfunctionNov 13, 2017Device Operational Issue; Device Operational Issue

  "TRAUMATIC BRAIN INJURY PATIENT IMPLANT THE CATHETER, WHEN CONNECT WITH THE CAM02 MONITOR CONSOLE, SHOW WITH "NO CATHETER CONNECTED", THEN AFTER ADJUSTING, SHOW WITH "0", ADJUST AGAIN SHOW WITH "-20", THE CATHETER COULD NOT CONNECT WITH CAM02 MONITOR CONSOLE SUCCESSFULLY. WHEN CAM02 MONITOR CONNECT WITH OTHER CAMCABL, COULD WORK SUCCESSFULLY." THERE WAS NO DEATH OR SERIOUS INJURY REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7025172 ↗
• MalfunctionNov 12, 2017Device Operational Issue; Device Operational Issue

  "CAMCABL (SN: (B)(4)) CONNECT WITH CAMIN02 (SN: (B)(4)), SOMETIMES WORK SOMETIMES DON'T WORK." THERE WAS NO INDICATION OF PATIENT DEATH OR SERIOUS INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7023754 ↗