Codman® CereLink® 826820Recalls & reported problems
Integra Lifesciences Production Corporation · Codman® CereLink® ICP Monitor · Class 2
Quick summary
This Codman CereLink ICP monitor measures pressure inside the skull. In 68 reports, it mostly describes readings that were wrong or drifted, error messages like "possible input failure," and units that stopped working, sometimes forcing a new sensor insertion; the reports include 1 death and 25 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 68
- Deaths reported
- 1
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10381780533788), received between Dec 2, 2021 and Apr 3, 2026 — classified as 1 death, 25 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Output Problem” (26 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
- Output Problem26
- Incorrect, Inadequate or Imprecise Result or Readings18
- Display or Visual Feedback Problem7
- Incorrect Measurement3
- Insufficient Device Problem Information3
- Failure to Read Input Signal2
- Image Display Error/Artifact2
- Sparking2
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- Insufficient Information13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Failure of Implant1
- Visual Disturbances1
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED A CERELINK MONITOR (ID 828620) WAS HAVING "INAPPROPRIATE VALUES" AND THEREFORE, THE SENSOR CONNECTED WITH THE MONITOR WAS EXPLANTED.
Patient problems: Insufficient Information
MAUDE report 24775296 ↗MalfunctionFeb 27, 2026Display or Visual Feedback Problem
2 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2026-00035, 3006697299-2026-00014. A FACILITY REPORTED A CODMAN SENSOR (ID 826850), A CODMAN MONITOR (ID 826820) AND A CERELINK EXTENSION CABLE (ID 826845) WERE USED TO MONITOR INTRACRANIAL PRESSURE IN A PATIENT IN INTENSIVE CARE UNIT. THE SYSTEM WAS WORKING FINE AND SUDDENLY STOPPED READING SHOWING ERROR "POSSIBLE INPUT FAILURE". PATIENT REQUIRED A NEW SENSOR INSERTION. ADDITIONAL INFORMATION RECEIVED: DATE OF EVENT ¿ 5 FEB 2026 IF USED WITH CERELINK: WAS THE PATIENT LEAD (ELECTRODE OF EXTENSION CABLE) ALWAYS CONNECTED TO THE PATIENT? YES IMPLANT LOCATION? SUB-DURAL DID THE ISSUE LEAD TO ANY PATIENT INJURY / COMPLICATIONS OR DEATH? NO WHAT WAS THE USER DOING (E.G., POWERING UNIT, ZEROING SENSOR, SETTING ALARM, DOWNLOADING DATA)? ERROR CAME UP SHORTLY AFTER IMPLANTATION. WHAT WAS HAPPENING WITH PATIENT (E.G., TRANSPORT, MRI, CT)? IN ICU CAN YOU PLEASE CONFIRM THAT THE REPLACEMENT WAS SUCCESSFUL AND ONLY THE SENSOR IS DEFECTIVE IN THIS CASE (NO ISSUE WITH MONITOR AND EXTENSION CABLE)? BOTH MONITOR AND SENSOR WERE ISOLATED AND A NEW MONITOR AND SENSOR WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469566 ↗MalfunctionDec 17, 2025Output Problem; Output Problem
THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2025-00328 3013886523-2025-00329 A NURSE REPORTED A CERELINK MONITOR (ID (B)(6) ) AND CERELINK SENSOR (ID (B)(6) ) HAVE AN ERROR MESSAGE. THE INTRACRANIAL PRESSURE (ICP) HAD DRIFTED LOWER AND LOWER UNTIL THEY STARTED TO READ NEGATIVE VALUES. THEREFORE, IT WAS REPLACED 5 DAYS AFTER ITS PLACEMENT. THEN THE SECOND SENSOR WAS PLACED IN THE PEDIATRIC INTENSIVE CARE UNIT (PICU) HOWEVER, IT FAILED 16 HOURS AFTER PLACEMENT. THE NURSE STATED THAT CERELINK FLASHED A WARNING SAYING THAT THE CERELINK WOULD RESTART IN 2 MINUTES. THE CERELINK TURNED OFF AND THEN TURNED BACK ON. WHEN IT TURNED ON, IT GAVE THE ERROR SCREENS. THE EKG LEAD WAS ATTACHED THE ENTIRE TIME AND REPLACED THE EKG PATCH AND TRIED A NEW CABLE TO SOLVE THE ISSUE. A NEW MONITOR WAS USED TO REPLACED; HOWEVER, ALL KEYS WERE UNABLE TO BE USED AND COULD ONLY SHUT THE MONITOR OFF.
Patient problems: Insufficient Information
MAUDE report 23829947 ↗MalfunctionDec 5, 2025Incorrect Measurement; Incorrect Measurement
MalfunctionAug 26, 2025Sparking; Sparking
IT WAS REPORTED THAT THE CERELINK ICP MONITOR (826820) "WAS ON AN IV POLE AND A BAG OF SOLUTION DRIPPED INTO THE POWER STRIP THAT IT WAS PLUGGED INTO AND AN ELECTRICAL SITUATION HAPPENED WHERE SPARKS WERE COMING OUT". STAFF PLUGGED IN A NEW CABLE, AND BELIEVED THE DEVICE WORKED FINE BUT WOULD LIKE DEVICE EVALUATED TO ENSURE IT IS WORKING TO SPECIFICATION. NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22895085 ↗MalfunctionJun 5, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE CERELINK ICP MONITOR (826820) "DOES NOT START ANYMORE". PATIENT WAS CONNECTED TO A NEW MONITOR THERE WAS REPORTEDLY AN HOUR DELAY IN PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22152495 ↗MalfunctionFeb 27, 2025Incorrect Measurement; Incorrect Measurement
3 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3006697299-2025-00024. 3014334038-2025-00028. THIS REPORT IS FOR CERELINK ICP MONITOR: A FACILITY REPORTED A CERELINK SYSTEM STARTED TO HAVE AN UNRELIABLE INCREASE IN THE PIC VALUE UP TO 40, PATIENT HAD A CT SCAN EXAM WHICH SHOWED ICP OF 80. THE REAL CORRECT ICP VALUE FOR THIS PATIENT WAS 15/20. FROM AN ANGIOGRAPHIC EXAM, THE CATHETER SEEMED BENT.; THEREFORE, IT WAS REMOVED AND REPLACED ON (B)(6) 2025; ONE DAY AFTER IMPLANTATION. PATIENT IN STABLE CONDITION AFTER REPLACEMENT. THE MONITOR DID NOT SHOW ANY ERROR MESSAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21483110 ↗MalfunctionFeb 27, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
InjurySep 26, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
DeathSep 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
InjuryJul 11, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
1 OF 3 COMPLAINTS (SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS). OTHER MFG REPORT NUMBERS: 3006697299-2024-00102 3013886523-2024-00202. A FACILITY REPORTED A PATIENT HAD A DECOMPRESSIVE CRANIECTOMY AND WAS ROLLED TO RELIEVE PRESSURE AREAS. NO DISCONNECTION OF CABLES OR MONITOR ALARMS. A SHORT TIME AFTER THE MONITOR MESSAGE WAS "SENSOR OR EXTENSION CABLE FAILURE". MEDICAL STAFF WAS UNABLE TO RESOLVE AS SCREEN WOULD NOT CHANGE, AND WAS UNABLE TO MONITOR ICPS. ALL TROUBLE SHOOTING CARRIED OUT CORRECTLY, AS THE SALES REPRESENTATIVE WAS THERE PERSONALLY TO TROUBLESHOOT. NEW MONITOR AND CABLES CONNECTED WHICH DISPLAYED THE SAME SCREEN. SENSOR SURGICALLY REMOVED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19721991 ↗MalfunctionMay 24, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2024-00152, 3013886523-2024-00153. A FACILITY REPORTED A CERELINK MICROSENSOR (ID 826851) WAS IMPLANTED ON (B)(6) 2024 AND WAS USED WITH THE CERELINK CABLE (ID (B)(6) ) FOR INTRACRANIAL PRESSURE (ICP) MONITORING. IT WAS STATED THAT THEY WERE GETTING A SENSOR/CABLE FAILURE MESSAGE. THE ICP WENT FROM 18 TO 150, THEN THE ERROR MESSAGE APPEARED. THE REFERENCE LEAD WAS ATTACHED AND WAS INSTRUCTED TO MOVE AND REPLACE THE ELECTROCARDIOGRAM (ECG) PATCH, SO THAT THE LEAD WOULD PEEL AWAY OR COME OFF. THE SENSOR HAD BEEN IN USE FOR APPROXIMATELY 10 HOURS AND WAS ALARMING FOR 10-15 MINUTES. THE CERELINK MONITOR (ID 826850) AND EXTENSION CABLE WERE SWITCHED OUT AND DISCONNECTED THE SENSOR FOR 30 MINUTES. THEY ATTEMPTED IT AGAIN, BUT THE ERROR REMAINED. ON (B)(6) 2024, THE SENSOR WAS REMOVED AND REPLACED. THE PATIENT IS IN A CRITICAL CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19391931 ↗InjuryMay 9, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
1 OF 3 REPORTS (SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS). OTHER MFG REPORT NUMBERS: 3006697299-2024-00055 AND 3013886523-2024-00138. A FACILITY REPORTED A CERELINK MONITOR (ID (B)(4) DISPLAYED ERROR CODE 1019 AND SENSOR OR EXTENSION CABLE FAILURE. THE EXPECTED OUTPUT VALUE WAS NOT GENERATED DURING BIT. REGISTRAR REVIEWED AND WAS UNABLE TO CALIBRATE THE MONITOR AND IT WAS SHOWING WRONG VALUES. MONITOR WAS TURNED OFF AGAIN DUE TO ERROR MESSAGE. THE SENSOR WAS EXPLANTED AND REPLACED. THE CABLE USED WITH THE SYSTEM IS CERELINK ICP EXT CABLE (B)(4).
Patient problems: Insufficient Information
MAUDE report 19282316 ↗MalfunctionApr 26, 2024Output Problem; Output Problem
InjuryApr 26, 2024Output Problem; Output Problem
4 OF 5 REPORTS (SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS). OTHER MFG REPORT NUMBERS: 3014334038-2024-00084 3006697299-2024-00045 3013886523-2024-00123 3006697299-2024-00047 A FACILITY REPORTED AN INTRACRANIAL PRESSURE (ICP) KIT WAS INSERTED ON (B)(6) 2024. THE ICP WAS 13-14 MMHG AND WENT SUDDENLY TO 35 AND THE PATIENT WAS TREATED WITH MANNITOL: PRESSURE DECREASED TO 11 MMHG. SUDDENLY THE CERELINK MONITOR WITH NO MOVEMENTS OR CHANGE, GAVE THE MESSAGE: ¿SENSOR OR EXTENSION CABLE FAILURE! DISCONNECT AND REPLACE CABLE OR SENSOR¿. THEY REPLACED THE CERELINK MONITOR AND THE CABLE WITH ANOTHER TWO UNITS, BUT THE MESSAGE REMAINED. THE EVENT LED TO 45 MINUTES DELAY IN PATIENT CARE. THEY SWITCHED OFF THE MONITOR BUT AFTER TURNING IT ON AGAIN THE MESSAGE KEPT BEING THE SAME. THEY HAD TO STOP THE MONITORING. THE PATIENT WAS CRITICAL, THEY NEEDED ICP MEASURING; THEREFORE, THE SENSOR WAS RETRIEVED, AND THE MONITORING METHOD WAS CHANGED TO EVD.
Patient problems: Insufficient Information
MAUDE report 19193148 ↗InjuryApr 26, 2024Unable to Obtain Readings; Unable to Obtain Readings
1 OF 3 REPORTS (SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS). OTHER MFG REPORT NUMBERS: 3006697299-2024-00044 3013886523-2024-00122 A FACILITY REPORTED A PATIENT HAD A CERELINK SENSOR PLACED (ID 826850). THE SENSOR WAS USED WITH CERELINK MONITOR (ID 826820) AND CERELINK CABLE (ID 826845). THE PROBLEMS STARTED IMMEDIATELY WITH A DECOMPRESSED PATIENT: AT A CERTAIN POINT THE MONITOR STARTED GIVING AN ERROR AND THE VALUE OF THE PRESSURE DISAPPEARED. THE PATIENT WAS CRITICAL AND THE EVENT LED TO A DELAY IN MEASURING THE INTRACRANIAL PRESSURE (ICP). THEREFORE, MEDICAL STAFF RETRIEVE THE SYSTEM. THE PATIENT DIED; HOWEVER, THE FACILITY CONFIRMED, THE DEATH IS RELATED TO THE PATIENT'S CRITICAL CONDITION (POLYTRAUMA).
Patient problems: Insufficient Information
MAUDE report 19192951 ↗InjuryApr 26, 2024Output Problem; Output Problem
1 OF 5 REPORTS (SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS). OTHER MFG REPORT NUMBERS: 3006697299-2024-00045. 3013886523-2024-00123. 3014334038-2024-00085. 3006697299-2024-00047. A FACILITY REPORTED AN INTRACRANIAL PRESSURE (ICP) KIT WAS INSERTED ON (B)(6) 2024. THE ICP WAS 13-14 MMHG AND WENT SUDDENLY TO 35 AND THE PATIENT WAS TREATED WITH MANNITOL: PRESSURE DECREASED TO 11 MMHG. SUDDENLY THE CERELINK MONITOR WITH NO MOVEMENTS OR CHANGE, GAVE THE MESSAGE: ¿SENSOR OR EXTENSION CABLE FAILURE! DISCONNECT AND REPLACE CABLE OR SENSOR¿. THEY REPLACED THE CERELINK MONITOR AND THE CABLE WITH ANOTHER TWO UNITS, BUT THE MESSAGE REMAINED. THE EVENT LED TO 45 MINUTES DELAY IN PATIENT CARE. THEY SWITCHED OFF THE MONITOR BUT AFTER TURNING IT ON AGAIN THE MESSAGE KEPT BEING THE SAME. THEY HAD TO STOP THE MONITORING. THE PATIENT WAS CRITICAL, THEY NEEDED ICP MEASURING; THEREFORE, THE SENSOR WAS RETRIEVED, AND THE MONITORING METHOD WAS CHANGED TO EVD.
Patient problems: Insufficient Information
MAUDE report 19192886 ↗InjuryApr 19, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
1 OF 3 REPORTS. OTHER MFG REPORT NUMBERS (SAME EVENT, SAME PATIENT, DIFFERENT PRODUCTS): 3006697299-2024-00042 3013886523-2024-00118. A FACILITY REPORTED THAT AFTER 5 DAYS USING THE CERELINK VENTRICULAR MICROSENSOR, THE CERELINK MONITOR DISPLAYED AN ERROR MESSAGE: 'REPLACE CABLE OR SENSOR¿, AFTER TRYING TO SWITCH OFF AND PLUGGING OUT AND IN THE CABLE, THE ALARM REMAINED ON THE SCREEN. ECG CONNECTION WAS ON AND THE MONITOR WAS CHARGING ALL THE TIME. MEDICAL STAFF STOP MONITORING, AND STARTED MONITORING WITH CT SCANS. THE PATIENT WAS MONITORED FOR INTRACRANIAL HYPERTENSION CAUSED BY TRAUMATIC BRAIN INJURY WITH CONTINUOUS MONITORING UNTIL THE DYSFUNCTION OF THE SENSOR.
Patient problems: Insufficient Information
MAUDE report 19143549 ↗MalfunctionApr 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2024-00095. A FACILITY REPORTED A PATIENT EXPERIENCED NEGATIVE READINGS OF A CERELINK MONITOR (826820) AND CERELINK SENSOR (B)(6). THE PATIENT HAD A READING OF 28MMHG, AND PHENOBARBITAL WAS GIVEN AT 0600. THE ICP DROPPED AS EXPECTED BUT CONTINUED TO -2 THEN SLOWLY INCREASED TO THE PATIENT¿S EXPECTED ICP AT 2PM. THE EVENT OCCURRED AGAIN IN MARCH 13. A MEDICATION WAS ADMINISTERED FOR HIGH ICP AT 0700 AND THE PATIENT EXPERIENCED A DROP PROGRESSIVELY TO NEGATIVE -2. THE MEDICATION COULD HAVE CAUSED THIS DROP BUT BECAUSE THE ICP USUALLY IN THE RANGE OF (B)(4) , MAKING IT NOT CONFIDENT IN THE NEGATIVE VALUES GIVEN. THE CERELINK MONITOR (826820) AND CERELINK SENSOR (B)(6) WERE USED ALONG WITH CABLE (7298286). THERE IS NO ISSUE WITH THE CABLE USED. THE CERELINK SENSOR (B)(6) WAS IMPLANTED ON (B)(6) 2024, AND WAS EXPLANTED ON (B)(6) 2024, AS THE SENSOR WAS NO LONGER REQUIRED FOR TREATMENT THE PATIENT DID NOT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO NEGATIVE READINGS, AND NO LONGER TREATMENT WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED: WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR: YES A, IF YES, PROVIDE P
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19018504 ↗MalfunctionApr 1, 2024Output Problem; Output Problem
A FACILITY REPORTED A CERELINK MONITOR ID (B)(4) SHOWED AN ERROR MESSAGE (ERROR CODE 1000) DURING A TRAUMATIC BRAIN INJURY (TBI) MONITORING IN THE INTENSIVE CARE UNIT (ICU). THE UNIT REBOOTED BY ITSELF AND WAS WORKING FINE AFTER THE ISSUE. EVERY TIME THE MONITOR MOVED A LITTLE THE SAME ERROR APPEARED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19011936 ↗MalfunctionJan 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED A CERELINK MONITOR (ID 314591) HAD NEGATIVE VALUES (-2 TO -1) WITH APPROPRIATE TROUBLESHOOTING. THE NEGATIVE VALUES LASTED ABOUT AN HOUR AT WHICH TIME IT REACHED AROUND 2-3 WHERE IT HAD BEEN BEFORE GOING NEGATIVE. PRODUCT WAS IN CONTACT WITH THE PATIENT; HOWEVER, NO PATIENT INJURY WAS REPORTED. ACCORDING TO REPORTER: "THE ISSUE SEEMS TO BE RESOLVED SO FAR BASED ON THE CUSTOMER'S FEEDBACK." NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18452085 ↗MalfunctionJan 4, 2024Output Problem; Output Problem
MalfunctionSep 26, 2023Output Problem; Output Problem
InjurySep 26, 2023No Device Output; No Device Output
MalfunctionAug 1, 2023Output Problem; Output Problem
Other Device, monitoring, intracranial pressure devices
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- Exacta™ 46705Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall117 reports
- CereLink™ 826850Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 recall2 deaths112 reports
- Duet® 46913Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall58 reports
- Becker® 26040Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall46 reports
- CereLink™ 826851Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure96 reports
- Becker® 46129Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall29 reports
- Codman Microsensor® 826631Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure75 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.