CODMAN® IPC EXPRESS® 826636Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® IPC EXPRESS® CABLE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780520481), received between Apr 5, 2024 and Mar 21, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (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.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement2
- Electrical Shorting1
Patient problems
- Cerebral Edema2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2025Incorrect Measurement; Incorrect Measurement
MalfunctionMar 21, 2025Incorrect Measurement; Incorrect Measurement
1 OF 3 REPORTS: OTHER MFG REPORT NUMBERS: 3014334038-2025-00040, 3013886523-2025-00055. A FACILITY REPORTED: "CODMAN MEASUREMENT DOES NOT WORK. MUST BE RESET MULTIPLE TIMES. PATIENT CRITICALLY ILL WITH LABILE ICP WITHOUT POSSIBILITY OF MEASUREMENT ON EVD. CODMAN CHANGED X 3 DURING DAY SHIFT AND BEGINNING OF EVENING SHIFT. MEASUREMENT IS SEEN AT ONE POINT ON CODMAN BUT CANNOT BE DISPLAYED ON SCREEN." "FINALLY, WITH THE HELP OF THE ANESTHESIA NURSE (FETCHED SEVERAL CODMAN) IT IS POSSIBLE TO GET THE CORRECT MEASUREMENTS. DURING SHIFT, PATIENT HAS DEVELOPED PUPIL DIFF DUE TO INCREASING EDEMA AND CODMAN HAS NOT SHOWN CORRECT MEASUREMENT. NEITHER ON CODMAN NOR SCREEN." PATIENT WAS URGENTLY TAKEN TO THE OPERATING ROOM FOR EVD PLACEMENT. CONSEQUENCE OF THE INCIDENT: MEDICAL OR SURGICAL TREATMENT WERE OTHER MEDICAL DEVICES USED IN CONNECTION WITH THE INCIDENT (E.G. ACCESSORIES)? YES. SEVERAL SERIAL NUMBERS IN USE IN THE DEPARTMENT: (B)(6), ETC. CABLES TO AND FROM THE ICP ELECTRODE IN THE BRAIN AND THE ONE OUT TO THE SCREEN CAN BE REPLACED BETWEEN THE DIFFERENT ICP MONITORS. ICP SENSOR (THE ELECTRODE IN THE BRAIN) THAT CONNECT TO THE ICP MONITOR: CERELINK (TM) ICP SENSOR, REFERENCE NUMBER: (
Patient problems: Cerebral Edema
MAUDE report 21664252 ↗MalfunctionApr 5, 2024Electrical Shorting; Electrical Shorting
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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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