CAMINO® 110-4HM (UDI 10381780258049)Recalls & reported problems
Integra Lifesciences Corporation · MICRO VENTRICULAR BOLT PRESSURE MONITORING KIT · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780258049), received between Nov 16, 2017 and Nov 29, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Operational Issue” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Operational Issue2
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 29, 2017Device Operational Issue; Device Operational Issue
FROM COMPLAINT INITIATION FORM RECEIVED 31 OCT 2017: "A CLINICIAN WITH NATUS RECEIVED A CALL FROM THE DR. (B)(6). HE PLACED A 110-4HM CATHETER ON (B)(6) 2017. ON DAY 5 ((B)(6) 2017) HE NOTICED A 10 DEGREE INCREASE IN ICP FROM THE MANUAL READINGS. HE WILL TRY TO SAVE THE CATHETER TO SEND IN FOR EVALUATION". "DEVICE IN CONTACT WITH PATIENT: YES". "PATIENT INJURY / DEATH ALLEGED: NO". "REVISION/MEDICAL INTERVENTION REQUIRED: NO". PATIENT PREPPED FOR SURGERY: NO". "DELAY IN SURGERY DUE TO LATE RECEIPT OF PRODUCT: NO". "DELAY IN SURGERY DUE TO PRODUCT PROBLEM: NO". "OUT OF BOX FAILURE(OOB): NO".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7069633 ↗MalfunctionNov 16, 2017Device Operational Issue; Device Operational Issue
"THE 1104HM 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." THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. THE DEVICE WAS IN CONTACT WITH THE PATIENT. THE CUSTOMER REPORTED NO REVISION OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THIS WAS NOT AN OUT-OF-BOX FAILURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SEE RELATED 2023988-2017-00503.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7037346 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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