CODMAN ICP EXPRESS 82-6636Recalls & reported problems
Cerenovus, Inc. · CODMAN ICP EXPRESS CABLE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704042365), received between Mar 31, 2023 and Mar 31, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Readings” (1 report).
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
- High Readings1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2023High Readings; High Readings
THIS IS 2 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00090, 3014334038-2023-00041, 3013886523-2023-00091. A FACILITY REPORTED A CERELINK SENSOR (ID (B)(4)) WAS IMPLANTED IN OPERATIVE ROOM FOR MONITORING INTRACRANIAL PRESSURE (ICP) OF AN ACUTE SUBARACHNOID HEMORRHAGE, BUT ONCE THE DRESSING WAS PLACED, THE READING BECAME ABNORMALLY HIGH. A NEW CERELINK SENSOR WAS INSERTED AND THE READINGS WERE STABLE. PATIENT WAS TRANSFERRED TO ICU BUT OVERNIGHT, THE READINGS BECAME ABNORMALLY HIGH AND ERRATIC. MEDICATION WAS GIVEN TO BRING ICP DOWN, HOWEVER THE PATIENT DID NOT RESPOND, ALTHOUGH DID NOT APPEAR TO BE SYMPTOMATIC EITHER. THE SENSOR WAS REMOVED AT BEDSIDE ON (B)(6) 2023 AND AN EVD WAS INSERTED WHICH GAVE A NORMAL ICP READING.
Patient problems: Insufficient Information
MAUDE report 16655821 ↗
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- Duet® 46913Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall58 reports
- CereLink™ 826851Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure96 reports
- Becker® 26040Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall46 reports
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- Codman Microsensor® 826631Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure75 reports
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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