CereLinkRecalls & reported problems across all models

We found 5 models of CereLink by Integra Lifesciences Production Corporation in the FDA's device registry (GUDID). Together they are named in 239 adverse event reports in the FDA's MAUDE database, received between Nov 2, 2021 and May 8, 2026 — classified as 4 deaths, 163 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (85 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

CereLink recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 12, 2025Class IIOpen, Classified

   Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

   Z-1037-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Oct 5, 2023Class IOpen, 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 · Recall details · FDA record ↗

Most reported CereLink problems

CereLink models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CereLink™ 826850

  Device, monitoring, intracranial pressure
  1 recall2 deaths112 reports
• CereLink™ 826851

  Device, monitoring, intracranial pressure
  96 reports
• CereLink™ 826845

  Device, monitoring, intracranial pressure
  1 recall2 deaths16 reports
• CereLink™ 826852

  Device, monitoring, intracranial pressure
  9 reports
• CereLink™ 826854

  Device, monitoring, intracranial pressure
  6 reports

Recent CereLink adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Nonstandard Device

  A FACILITY REPORTED A CERELINK VENTRICULAR CATHETER WITH ICP SENSOR (ID 826854) GAVE AN ERROR MESSAGE ("SENSOR ERROR REPLACE¿). THE MONITOR AND THE CABLE WERE REPLACED, HOWEVER, REPLACING THE SENSOR FIXED THE PROBLEM. IT IN UNKNOWN IF THE EVENT HAPPENED DURING OR AFTER IMPLANTATION PROCEDURE. NO ADDITIONAL INFORMATION WAS RECEIVED AFTER SEVERAL ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123265 ↗
• MalfunctionApr 10, 2026No Device Output

  A FACILITY REPORTED A CERELINK SENSOR (ID: 826851) WAS IMPLANTED. THE DEVICE STOPPED READING AFTER BEING IMPLANTED FOR SEVERAL DAYS, WHILE THE NURSING STAFF WAS BOOSTING PATIENT IN BED. SENSOR WAS NOT RETRIEVED DUE TO THE EVENT. ADDITIONAL INFORMATION: IMPLANT LOCATION (EX: PARENCHYMA): PARENCHYMA. WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR: YES. IF YES, PROVIDE PATIENT MONITOR MAKE & MODEL: DRAGER. WAS THE PATIENT LEAD ALWAYS CONNECTED: MOST OF TIME, RN DID NOT IT CAME OFF AROUND THE TIME OF FAILURE WHILE BOOSTING PATIENT IN BED. WHAT WAS HAPPENING WITH PATIENT: SENSOR MOMENTARILY SHOWED 149 FOR ICP, THEN IMMEDIATELY WENT INTO CABLE FAILURE MODE.

  Patient problems: Insufficient Information

  MAUDE report 24843968 ↗
• MalfunctionMar 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712075 ↗
• InjuryMar 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  2 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3006697299-2026-00024, 3014334038-2026-00025. A FACILITY REPORTED: THE MONITORED ICP PRESSURE READINGS GETTING LOWER AND LOWER UNTIL IT DISAPPEARS FROM THE MONITOR SCREEN ALL TOGETHER. IT WAS RE-CALIBRATED AND FUNCTIONALLY CHECKED & TESTED USING AN IN-HOUSE TEST SENSOR AND ALL SEEMS TO BE WORKING CORRECTLY. PATIENT PRESSURES READING 28. MONITOR SPONTANEOUSLY SHOWED VARYING PRESSURES FROM MINUS 20 TO PLUS10. MESSAGE: "POSSIBLE INPUT FAILURE. VERIFY SENSOR,CABLE, AND LEAD CONNECTIONS". THE EARTHING WIRE WAS ATTACHED TO THE PATIENT. THEN THE MESSAGE: "PATIENT MONITOR CONNECTION ERROR, RECONNECT MONITOR AGAIN"; PATIENT WAS NEVER DISCONNECTED. THEN MONITOR SHOWED NO PRESSURE READINGS. MOVED PATIENTS HEAD AND PRESSURES REAPPEARED. THEN NUMERICAL PRESSURES DISAPPEARED AGAIN. MONITOR RE-ZEROED AND TURNED OFF AND ON. MESSAGE: "POSSIBLE INPUT FAILURE VERIFY SENSORS,CABLES AND LEAD CONNECTIONS" REAPPEARED. THERE WAS ALWAYS A CONTINOUS ERROR MESSAGE THROUGHOUT THE INCIDENT. EVD TRANSDUCED AND SHOWED ICPS 18. MEDIC NOTIFIED AND REFERRAL TO NEUROSURGEONS, EVD HAD BEEN TRANSDUCED EARLIER TO CHECK PRESSURE AND AT THAT POINT BOTH THE CERELINK AND EVD PRESSU

  Patient problems: Insufficient Information

  MAUDE report 24592625 ↗
• MalfunctionMar 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A CERELINK SENSOR (ID 826850) FAILED WHILE IN USE. LOOKING THROUGH THE ERROR LOGS IT WAS FOUND MULTIPLE "SENSOR WARNING: MEAN ICP VALUE EXCEEDED THE VALID RANGE:" MESSAGES. THE RECORDED VALUES ARE BETWEEN -84 TO -360MMHG. PATIENT REQUIRED AN MRI SCAN OF HEAD. ICP MONITOR IN SITU WHICH REQUIRED GAUZE AND COILING AWAY FROM THE SKIN PRE SCAN. THIS WAS DONE INCORRECTLY AND NEEDED RE-DOING MULTIPLE TIMES LEADING TO HIGHER RISK OF DISLODGEMENT. PATIENT ADMITTED TO HOSPITAL WITH A INTRAPARENCHYMAL BLEED AND HAS THE ICP MONITOR IN STILL (24 DAYS) DUE TO CONTINUING ICP SPIKES AND HYDROCEPHALUS. MRI COMPLETED SAFELY HOWEVER ICP NOW READING NEGATIVE NUMBERS AND IS NOT SUTURED IN. ?ACCIDENTALLY DISLODGED OR MOVED SLIGHTLY. ADDITIONAL INFORMATION RECEIVED: - SENSOR REFERENCE? 826850 - SENSOR LOT NUMBER? UNKNOWN - EXTENSION CABLE LOT NUMBER? UNKNOWN - DATE OF EVENT? 18/02/2026 - WAS THE PATIENT LEAD (ELECTRODE OF EXTENSION CABLE) ALWAYS CONNECTED TO THE PATIENT? YES - IMPLANT LOCATION - PARENCHYMAL - DID THE ISSUE LEAD TO ANY PATIENT INJURY / COMPLICATIONS OR DEATH?ANSWER : NO - DID THE ISSUE LEAD TO A CRITICAL DELAY IN PATIENT CARE ? NO - WHAT WAS THE USER DOING (E.G., POWER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586643 ↗
• MalfunctionMar 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507137 ↗
• 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 ↗
• InjuryFeb 27, 2026Output Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469568 ↗
• 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 ↗
• InjuryFeb 6, 2026Improper or Incorrect Procedure or Method

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278014 ↗
• InjuryFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THIS IS 4 OF 5 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2026-00015, 3013886523-2026-00016, 3013886523-2026-00017. A FACILITY REPORTED THAT MULTIPLE SENSORS (ID 826851) PRODUCED NEGATIVE READINGS DURING THE PERIOD OF (B)(6) 2025, THROUGH (B)(6) 2026. CLINICAL TROUBLESHOOTING WAS PERFORMED AT THE TIME OF USE. THE LEAD WAS CONFIRMED TO BE PROPERLY CONNECTED AND IN PLACE, THE MICROSENSOR DEPTH WAS VERIFIED TO BE CORRECT, AND THE DEVICE WAS ZEROED ACCORDING TO INSTRUCTIONS FOR USE. DESPITE THESE ACTIONS, EACH IMPLANTED SENSOR CONTINUED TO DISPLAY NEGATIVE READINGS. A TOTAL OF FIVE (5) MICROSENSORS WERE IMPLANTED AND REMOVED AND REPLACED DUE TO CONTINUED NEGATIVE READINGS. NO SURGICAL DELAY OCCURRED, AND THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS, OR ADVERSE EFFECTS RELATED TO THE DEVICE ISSUE. AFTER THE FIFTH REPLACEMENT AND CONTINUED NEGATIVE READINGS, MONITORING WAS DISCONTINUED AS IT WAS NO LONGER CLINICALLY NEEDED. ADDITIONAL INFORMATION RECEIVED: - IMPLANT LOCATION - "PARENCHYMA" - WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR - "YES, CERELINK MONITOR" - WAS THE PATIENT LEAD ALWAYS CONNECTED - "YES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278012 ↗
• InjuryFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THIS IS 5 OF 5 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2026-00015 3013886523-2026-00016, 3013886523-2026-00017, 3013886523-2026-00018. A FACILITY REPORTED THAT MULTIPLE SENSORS (ID 826851) PRODUCED NEGATIVE READINGS DURING THE PERIOD OF (B)(6) 2025, THROUGH (B)(6) 2026. CLINICAL TROUBLESHOOTING WAS PERFORMED AT THE TIME OF USE. THE LEAD WAS CONFIRMED TO BE PROPERLY CONNECTED AND IN PLACE, THE MICROSENSOR DEPTH WAS VERIFIED TO BE CORRECT, AND THE DEVICE WAS ZEROED ACCORDING TO INSTRUCTIONS FOR USE. DESPITE THESE ACTIONS, EACH IMPLANTED SENSOR CONTINUED TO DISPLAY NEGATIVE READINGS. A TOTAL OF FIVE (5) MICROSENSORS WERE IMPLANTED AND REMOVED AND REPLACED DUE TO CONTINUED NEGATIVE READINGS. NO SURGICAL DELAY OCCURRED, AND THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS, OR ADVERSE EFFECTS RELATED TO THE DEVICE ISSUE. AFTER THE FIFTH REPLACEMENT AND CONTINUED NEGATIVE READINGS, MONITORING WAS DISCONTINUED AS IT WAS NO LONGER CLINICALLY NEEDED. ADDITIONAL INFORMATION RECEIVED: IMPLANT LOCATION - "PARENCHYMA" WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR - "YES, CERELINK MONITOR." WAS THE PATIENT LEAD ALWAYS CONNECTED - "YES"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278008 ↗
• InjuryFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THIS IS 2 OF 5 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2026-00015, 3013886523-2026-00017, 3013886523-2026-00018, 3013886523-2026-00019. A FACILITY REPORTED THAT MULTIPLE SENSORS (ID 826851) PRODUCED NEGATIVE READINGS DURING THE PERIOD OF (B)(6) 2025, THROUGH (B)(6) 2026. CLINICAL TROUBLESHOOTING WAS PERFORMED AT THE TIME OF USE. THE LEAD WAS CONFIRMED TO BE PROPERLY CONNECTED AND IN PLACE, THE MICROSENSOR DEPTH WAS VERIFIED TO BE CORRECT, AND THE DEVICE WAS ZEROED ACCORDING TO INSTRUCTIONS FOR USE. DESPITE THESE ACTIONS, EACH IMPLANTED SENSOR CONTINUED TO DISPLAY NEGATIVE READINGS. A TOTAL OF FIVE (5) MICROSENSORS WERE IMPLANTED AND REMOVED AND REPLACED DUE TO CONTINUED NEGATIVE READINGS. NO SURGICAL DELAY OCCURRED, AND THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS, OR ADVERSE EFFECTS RELATED TO THE DEVICE ISSUE. AFTER THE FIFTH REPLACEMENT AND CONTINUED NEGATIVE READINGS, MONITORING WAS DISCONTINUED AS IT WAS NO LONGER CLINICALLY NEEDED. ADDITIONAL INFORMATION RECEIVED: - IMPLANT LOCATION - "PARENCHYMA" - WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR - "YES, CERELINK MONITOR" - WAS THE PATIENT LEAD ALWAYS CONNECTED - "YES"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277682 ↗
• InjuryFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277673 ↗
• InjuryFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277660 ↗

Other Integra Lifesciences Production Corporation products

• CODMAN54 models · 353 reports · 31 recalls
• CODMAN BACTISEAL13 models · 136 reports · 3 recalls
• Codman Microsensor7 models · 207 reports · 1 recall
• Integra Miltex21 models · 69 reports · 2 recalls
• CODMAN HAKIM36 models · 162 reports
• Integra Jarit57 models · 79 reports