CODMAN® 826881Recalls & reported problems
Integra LifeSciences Switzerland Sàrl · Codman® Patient Monitor Interface Cable - Philips (12 Pin) · 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 10381780520726), received between Jul 25, 2025 and Jul 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “No Device Output” (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.
Reports received per month
Most reported problems
Device problems
- No Device Output1
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.
MalfunctionJul 25, 2025No Device Output; No Device Output
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00198. A FACILITY REPORTED A CERELINK SENSOR (ID: 826851) WAS PLACED ON (B)(6) 2025, CONNECTED TO A PHILIPS MONITOR CABLE (ID: 826881). THE PATIENT EXPERIENCED A TRAUMATIC BRAIN INJURY (TBI), WHO ALSO HAD A DRAIN AND WAS INTUBATED. THE BEDSIDE NURSE REPORTED THAT THE MONITOR STOPPED WORKING WHEN SHE LAID A BLANKET OVER THE PATIENT. THE PATIENT HAD NOT BEEN TRANSPORTED AND WAS IN A PHENOBARBITAL-INDUCED COMA. THE ACCOUNT MANAGER STATED: "I ASKED THE NURSE TO SHOW ME THE TREND SCREEN, I DIDN'T SEE THE 'LINE' THAT TYPICALLY INDICATES AN ESD SHOCK, WHICH I WAS INSTRUCTED TO LOOK FOR. THE NURSE TURNED OFF THE MONITOR AND DISCONNECTED IT FROM THE PATIENT FOR 30 MINUTES, THEN ATTEMPTED TO RECONNECT IT, BUT WAS UNSUCCESSFUL. THE REFERENCE LEAD WAS ATTACHED. THE NURSE ALSO TRIED SWAPPING OUT THE ENTIRE MONITOR AND CORD, BUT THE SENSOR STILL DID NOT WORK." IT WAS ALSO NOTED THAT "THE NURSE WAS VERY CLEAR THAT THIS COULD HAVE CAUSED AN INJURY IF THE SENSOR HAD NOT BEEN IN PLACE FOR SO LONG." DUE TO THE ISSUE, THE SENSOR WAS REMOVED. ADDITIONAL INFORMATION: IMPLANT LOCATION: "PARENCHYMAL." HOSPITAL LOCATION OF IMPLANT: "OPERA
Patient problems: Insufficient Information
MAUDE report 22608267 ↗
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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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