CAMINO® 110-4G (UDI 10381780025511)Recalls & reported problems
Integra Lifesciences Corporation · POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT · Class 2
All models of CAMINO (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780025511), received between Apr 19, 2019 and Sep 20, 2019 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (3 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
Device problems
- Unable to Obtain Readings3
- Inappropriate Waveform1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Known Impact Or Consequence To Patient5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2019Unable to Obtain Readings; Unable to Obtain Readings
CATHETER SUDDENLY STOPPED MONITORING 3 DAYS AFTER IMPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9097785 ↗MalfunctionJun 27, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
CATHETER WOULD NOT INITIALIZE OR REGISTER. HAD TO BE REPLACED WITH SECOND CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8739228 ↗MalfunctionApr 19, 2019Unable to Obtain Readings; Unable to Obtain Readings
OUTPUT VALUE DID NOT REGISTER DURING RECONNECTION AFTER TRANSFER OF PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8533479 ↗MalfunctionApr 19, 2019Unable to Obtain Readings; Unable to Obtain Readings
OUTPUT VALUE DID NOT REGISTER DURING RECONNECTION AFTER TRANSFER OF PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8533471 ↗MalfunctionApr 19, 2019Inappropriate Waveform; Inappropriate Waveform
WAVEFORM OUTPUT NOT DISPLAYED WHILE IN USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8533467 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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