CereLink™ 826845Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10381780520665), received between Apr 6, 2022 and Feb 27, 2026 — classified as 2 deaths, 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Output Problem” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 5, 2023Open, Classified

   Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.

   Z-0548-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Insufficient Device Problem Information

  2 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3014334038-2026-00018, 3013886523-2026-00044. A FACILITY REPORTED A CERELINK SYSTEM (SENSOR/MONITOR/CABLE) WAS USED ON A PATIENT. THE MONITOR STOPPED WORKING SHOWING MESSAGE: "POSSIBLE INPUT FAILURE. VERIFY SENSOR, CABLES AND PATIENT LEAD CONNECTIONS.". THEREFORE, THE SENSOR WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469587 ↗
• MalfunctionFeb 27, 2026Display or Visual Feedback Problem

  1 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2026-00035, 3014334038-2026-00017. 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 24469565 ↗
• MalfunctionFeb 27, 2025Incorrect Measurement; Incorrect Measurement

  1 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3014334038-2025-00028. 3014334038-2025-00029. THIS REPORT IS FOR CERELINK ICP EXT CABLE ID 826845: 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 21483113 ↗
• MalfunctionFeb 27, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  2 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3014334038-2025-00030, 3014334038-2025-00032. THIS REPORT IS FOR CERELINK ICP EXT CABLE: A FACILITY REPORTED A CERELINK MONITOR DISPLAYED "SENSOR FAILURE" WHILE IN USE IN THE INTENSIVE CARE UNIT. THE SENOR WAS REMOVED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.

  Patient problems: Insufficient Information

  MAUDE report 21483106 ↗
• InjuryJul 11, 2024Output Problem; Output Problem

  2 OF 3 COMPLAINTS (SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS). OTHER MFG REPORT NUMBERS: 3014334038-2024-00147 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 19722015 ↗
• MalfunctionApr 19, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  2 OF 3 REPORTS. OTHER MFG REPORT NUMBERS (SAME EVENT, SAME PATIENT, DIFFERENT PRODUCTS): 3014334038-2024-00080 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 19143551 ↗
• MalfunctionMar 11, 2024Output Problem; Output Problem

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 18874098 ↗
• MalfunctionAug 17, 2022Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00370 AND 3014334038-2022-00179 A FACILITY REPORTED A CABLE/SENSOR FAILURE ERROR MESSAGE. THEY TRIED SWITCHING OUT MONITORS AND CABLES, WITH NO LUCK. A NURSE WAS INSTRUCTED TO DISCONNECT THE MICROSENSOR FROM THE CABLE TO THE MONITOR; HOWEVER, THE NURSE DISCONNECTED THE YELLOW PATIENT SENSOR FROM THE MICROSENSOR. THEY COMPLETELY TOOK IT APART AND EVEN THE WHITE MICROSENSOR BOX ITSELF. THEREFORE, THE SURGEON HAD TO REPLACE THE BOLT DUE TO THE NURSES MISTAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242787 ↗
• MalfunctionJun 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A PATIENT WAS MOVED AND CERELINK WAS DISCONNECTED DURING MOVE. WHEN THE CERELINK WAS RECONNECTED TO THE SENSOR IT SHOWED A NEGATIVE ICP AND AN ERROR MESSAGE ¿SENSOR OR EXTENSION CABLE FAILURE. SALES REPRESENTATIVE REPLACED THE EXTENSION CABLE AND WAS ABLE TO REESTABLISH A READING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754250 ↗
• MalfunctionJun 6, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THIS IS 7 OF 7 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2022-00161, 3013886523-2022-00162, 3013886523-2022-00163, 3014334038-2022-00072, 3013886523-2022-00242 AND 3013886523-2022-00240. IT WAS REPORTED A PATIENT WENT TO THE OPERATING ROOM AND HAD FIRST SENSOR IMPLANTED SUCCESSFULLY ON (B)(6) 2022. SENSOR WAS READING BETWEEN 3-5 IN OPERATING ROOM AND -1 TO 3 IN POST-ANESTHESIA CARE UNIT (PACU). CERELINK WAS NOT PLUGGED IN AND ON THE PATIENT'S BED. PATIENT WAS TRANSPORTED TO THE PEDIATRIC INTENSIVE CARE UNIT (PICU). IN THE PICU, PATIENT¿S INTRACRANIAL PRESSURE (ICP) WENT TO -23 WITH A WAVE FORM, ALARMED, THEN WENT TO -50 WITH SENSOR/CABLE FAILURE. MONITOR WAS STILL UNPLUGGED FROM THE WALL. UNPLUGGED THE SENSOR FROM THE MONITOR FOR 20 MINUTES. AFTER 20 MINUTES, MONITOR STILL DIDN¿T WORK. RESTED FOR A FURTHER 30 MINUTES AND CHANGED THE CABLE. WHEN THE SENSOR WAS PLUGGED IN, IT GOT AN APPROPRIATE WAVEFORM FOR A SECOND, THEN IMMEDIATELY THE WAVE FORM DROPPED NEGATIVE WITH SENSOR CABLE FAILURE. UNPLUGGED THE SENSOR AND TURNED EVERYTHING OFF FOR AN HOUR, REPLACED THE CORD, THEN PLUGGED THE MONITOR INTO THE WALL. UPON PLUGGING THE SENSOR IN, IT HAD A WAVE FORM AND NEGATIVE READING IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605711 ↗
• MalfunctionJun 6, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THIS IS 6 OF 7 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2022-00161, 3013886523-2022-00162, 3013886523-2022-00163, 3014334038-2022-00072, 3013886523-2022-00242, 3013886523-2022-00241. IT WAS REPORTED A PATIENT WENT TO THE OPERATING ROOM AND HAD FIRST SENSOR IMPLANTED SUCCESSFULLY ON (B)(6) 2022. SENSOR WAS READING BETWEEN 3-5 IN OPERATING ROOM AND -1 TO 3 IN POST-ANESTHESIA CARE UNIT (PACU). CERELINK WAS NOT PLUGGED IN AND ON THE PATIENT'S BED. PATIENT WAS TRANSPORTED TO THE PEDIATRIC INTENSIVE CARE UNIT (PICU). IN THE PICU, PATIENT¿S INTRACRANIAL PRESSURE (ICP) WENT TO -23 WITH A WAVE FORM, ALARMED, THEN WENT TO -50 WITH SENSOR/CABLE FAILURE. MONITOR WAS STILL UNPLUGGED FROM THE WALL. UNPLUGGED THE SENSOR FROM THE MONITOR FOR 20 MINUTES. AFTER 20 MINUTES, MONITOR STILL DIDN¿T WORK. RESTED FOR A FURTHER 30 MINUTES AND CHANGED THE CABLE. WHEN THE SENSOR WAS PLUGGED IN, IT GOT AN APPROPRIATE WAVEFORM FOR A SECOND, THEN IMMEDIATELY THE WAVE FORM DROPPED NEGATIVE WITH SENSOR CABLE FAILURE. UNPLUGGED THE SENSOR AND TURNED EVERYTHING OFF FOR AN HOUR, REPLACED THE CORD, THEN PLUGGED THE MONITOR INTO THE WALL. UPON PLUGGING THE SENSOR IN, IT HAD A WAVE FORM AND NEGATIVE READING IN TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605621 ↗
• MalfunctionJun 1, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS IS 5 OF 7 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2022-00161, 3013886523-2022-00162, 3013886523-2022-00163, 3014334038-2022-00072, 3013886523-2022-00240, 3013886523-2022-00241. IT WAS REPORTED A PATIENT WENT TO THE OPERATING ROOM AND HAD FIRST SENSOR IMPLANTED SUCCESSFULLY ON (B)(6) 2022. SENSOR WAS READING BETWEEN 3-5 IN OPERATING ROOM AND -1 TO 3 IN POST-ANESTHESIA CARE UNIT (PACU). CERELINK WAS NOT PLUGGED IN AND ON THE PATIENT'S BED. PATIENT WAS TRANSPORTED TO THE PEDIATRIC INTENSIVE CARE UNIT (PICU). IN THE PICU, PATIENT¿S INTRACRANIAL PRESSURE (ICP) WENT TO -23 WITH A WAVE FORM, ALARMED, THEN WENT TO -50 WITH SENSOR/CABLE FAILURE. MONITOR WAS STILL UNPLUGGED FROM THE WALL. UNPLUGGED THE SENSOR FROM THE MONITOR FOR 20 MINUTES. AFTER 20 MINUTES, MONITOR STILL DIDN¿T WORK. RESTED FOR A FURTHER 30 MINUTES AND CHANGED THE CABLE. WHEN THE SENSOR WAS PLUGGED IN, IT GOT AN APPROPRIATE WAVEFORM FOR A SECOND, THEN IMMEDIATELY THE WAVE FORM DROPPED NEGATIVE WITH SENSOR CABLE FAILURE. UNPLUGGED THE SENSOR AND TURNED EVERYTHING OFF FOR AN HOUR, REPLACED THE CORD, THEN PLUGGED THE MONITOR INTO THE WALL. UPON PLUGGING THE SENSOR IN, IT HAD A WAVE FORM AND NEGATIVE READING IN TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569135 ↗
• MalfunctionMay 20, 2022Image Display Error/Artifact; Image Display Error/Artifact

  THIS IS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00204, 3014334038-2022-00106. A FACILITY REPORTED A CERELINK SENSOR (UNKNOWN ID) WAS PLACED IN THE RIGHT FRONTAL LOBE VIA A BOLT (METAL SKULL BOLT KIT) OF A PATIENT WITH TRAUMATIC BRAIN INJURY (TBI) ON (B)(6) 2022 AT 21:00. AFTER 24 HOURS OF ADMISSION DUE TO THE ICP KEPT SPIKING THE PATIENT HAD A LEFT FRONTOPARIETAL DECOMPRESSIVE HEMICRANIECTOMY PERFORMED. ON (B)(6) 2022 (MORNING) THE ICP WAS ~12MMHG TO 15MMHG MOST OF THE DAY WITH OCCASIONAL SPIKING ~20MMHG (NOT SUSTAINED). LATER, THE NURSE NOTICED THE ICP WAS DRIFTING DOWN TO ~2-3MMHG WITH A POOR WAVEFORM. THE PATIENT WAS SCHEDULED FOR A POST-OP CT. PRIOR TO CT, THE ICP WAS 2MMHG TO 3MMHG WITH A POOR WAVEFORM; BUT UPON ARRIVAL BACK TO THE ICU, THE ERROR CODE APPEARED ON THE CERELINK ICP MONITOR. DURING TRANSPORT TO THE CT SCANNER, THE NURSE DID NOT TAKE THE CERELINK MONITOR. SHE DISCONNECTED THE ICP EXTENSION CABLE FROM THE MICROSENSOR. TROUBLESHOOTING STEPS THEY TOOK ¿ ALL WERE UNSUCCESSFUL: REBOOTED THE CERELINK = (ERROR CODE REMAINED). TURNED THE CERELINK OFF X 5 MINUTES ¿ THEN TURNED BACK ON = (ERROR CODE REMAINED). CHANGED OUT ICP EXTENSION CABLE = (ERROR CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14458989 ↗
• MalfunctionApr 12, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THIS IS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2022-00134, 3014334038-2022-00068. A FACILITY REPORTED A CERELINK MICROSENSOR WAS PLACED IN THE LEFT SIDE OF THE BRAIN IN A (B)(6)-MONTH-OLD PATIENT WITH TRAUMATIC BRAIN INJURY. THE READING WENT TO -10, THEN THE CERELINK MONITOR ALARMED "SENSOR FAILURE", THEN WENT TO "SENSOR /CABLE FAILURE". THE CABLES AND MONITOR WERE REPLACED; HOWEVER, IT WAS STILL READING A NEGATIVE ICP. THEN THE SENSOR WAS REPLACED AND PLACED IN THE RIGHT SIDE OF THE BRAIN WITH A NEW CERELINK MONITOR AND THE SENSOR WAS WORKING AS INTENDED.

  Patient problems: Insufficient Information

  MAUDE report 14084003 ↗
• DeathApr 6, 2022Output Problem; Output Problem

  1 OF 2 REPORTS. SAME PATIENT, DIFFERENT CABLES. OTHER MFG REPORT NUMBER: 3013886523-2022-00127. A FACILITY REPORTED A MALE PATIENT (MID TO LATE 50'S) HAD A SERIOUS HEAD INJURY AFTER AN ACCIDENT. AN ICP SENSOR KIT WAS IMPLANTED AND CONNECTED TO CERELINK ICP MONITOR ( SN ¿ (B)(4)). THE CERELINK MONITOR DISPLAYED WHAT APPEARED TO BE A RELATIVELY STABLE READING OR AROUND 20MMHG FOR THE FOLLOWING 2 DAYS. PHYSICIAN ATTENDED TO ASSESS THE PATIENT AND DISCOVERED THAT THE METAL SKULL BOLT APPEARED TO HAVE BEEN INCORRECTLY FITTED AND WAS ¿FLAPPING¿ ABOUT. THIS CREATED A CONCERN THAT THE ICP READING WERE POSSIBLY INCORRECT, THEN PROCEEDED TO INSERT A LICOX BOLT AND REINSERT THE ICP SENSOR WHICH THEN READ AN INCREASED ICP OF AROUND 50MMHG +/-. AS THEY PROCEEDED TO MONITOR THE ICP SOMETIME AFTER THIS ¿ THE CERELINK MONITOR DISPLAYED THE ERROR ¿ ¿CONNECTING CABLE MALFUNCTION¿. THEY DECIDED TO CHANGE THE CERELINK MONITOR (TO MONITOR SN (B)(4)), CABLE (A NEW ONE OF THEIR OWN) AND SENSOR. THE ICP READINGS STAYED VERY HIGH, DISPLAYING THE SAME MESSAGE APPROXIMATELY 20 MINUTES AFTER BEING CHANGED OVER. A NEW CABLE WAS USED AND REMOVED THE FAULTY CABLE. THE PATIENT WAS THEN TAKEN FOR A SCAN AND DURING

  Patient problems: Insufficient Information

  MAUDE report 14021742 ↗
• DeathApr 6, 2022Output Problem; Output Problem

  2 OF 2 REPORTS. SAME PATIENT, DIFFERENT CABLES. OTHER MFG REPORT NUMBER: 3013886523-2022-00126. A FACILITY REPORTED A MALE PATIENT (MID TO LATE 50'S) HAD A SERIOUS HEAD INJURY AFTER AN ACCIDENT. AN ICP SENSOR KIT WAS IMPLANTED AND CONNECTED TO CERELINK ICP MONITOR ( SN:(B)(4)). THE CERELINK MONITOR DISPLAYED WHAT APPEARED TO BE A RELATIVELY STABLE READING OR AROUND 20MMHG FOR THE FOLLOWING 2 DAYS. PHYSICIAN ATTENDED TO ASSESS THE PATIENT AND DISCOVERED THAT THE METAL SKULL BOLT APPEARED TO HAVE BEEN INCORRECTLY FITTED AND WAS ¿FLAPPING¿ ABOUT. THIS CREATED A CONCERN THAT THE ICP READING WERE POSSIBLY INCORRECT, THEN PROCEEDED TO INSERT A LICOX BOLT AND REINSERT THE ICP SENSOR WHICH THEN READ AN INCREASED ICP OF AROUND 50MMHG +/-. AS THEY PROCEEDED TO MONITOR THE ICP SOMETIME AFTER THIS ¿ THE CERELINK MONITOR DISPLAYED THE ERROR ¿ ¿CONNECTING CABLE MALFUNCTION¿. THEY DECIDED TO CHANGE THE CERELINK MONITOR (TO MONITOR SN:(B)(4)), CABLE (A NEW ONE OF THEIR OWN) AND SENSOR. THE ICP READINGS STAYED VERY HIGH, DISPLAYING THE SAME MESSAGE APPROXIMATELY 20 MINUTES AFTER BEING CHANGED OVER. A NEW CABLE WAS USED AND REMOVED THE FAULTY CABLE. THE PATIENT WAS THEN TAKEN FOR A SCAN AND DURING T

  Patient problems: Insufficient Information

  MAUDE report 14021740 ↗