CereLink™ 826852Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10381780520696), received between Nov 2, 2021 and Dec 11, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A DISCREPANCY BETWEEN INTRACRANIAL PRESSURE (ICP) VALUES MEASURED BY A CERELINK SENSOR (ID: (B)(6) AND AN EXTERNAL VENTRICULAR DRAIN (EVD) TRANSDUCER. THE SENSOR WAS PLACED ON (B)(6) 2025. THEY ARE RELYING ON THE EVD FOR ACCURATE MEASUREMENTS, CHECKING THE SETUP AND INSERTION SITE, AND PERFORMING RECALIBRATION. THE EVD USED WAS THE MEDTRONIC DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM. ADDITIONAL INFORMATION: - WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONITOR: YES. - WAS THE PATIENT LEAD ALWAYS CONNECTED: YES.

  Patient problems: Insufficient Information

  MAUDE report 23782469 ↗
• InjuryFeb 27, 2025Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21483318 ↗
• InjuryFeb 27, 2025Incorrect Measurement; Incorrect Measurement

  1 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3006697299-2025-00024, 3014334038-2025-00029. THIS REPORT IS FOR A CERELINK ICP PROBE 1L P BOLT: ID 826852: 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 21483109 ↗
• InjuryMay 17, 2024Output Problem; Output Problem

  A FACILITY REPORTED THE CERELINK SENSOR IS FRAGILE AND DOES NOT ALLOW MONITORING 10 DAYS AFTER IMPLANTATION. THEREFORE, SENSOR WAS REMOVED DUE TO FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 19346831 ↗
• InjuryAug 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A CERELINK ICP MICROSENSOR WAS PLACED VIA METAL SKULL BOLT ON (B)(6) 2023. ON (B)(6) 2023, THE ICP XPRESS UNIT READ AND ICP MEAN OF 0 TO -1, AND THE WAVEFORM ON THE PATIENT MONITOR FLUCTUATED BETWEEN -5 TO 5. PATIENT SEDATED WITH PROPOFOL AND FENTANYL, EQUALLY REACTIVE PUPILS. THE PATIENT WAS BRONCHED PRIOR TO CALLING CLINICAL SPECIALIST, AND PATIENT¿S HEART RATE INCREASED DURING THE BRONCH BUT THE ICP REMAINED -1 TO 0. CHARGE NURSE INSPECTED LEAD WIRE OF SENSOR AND REPORTED THAT IT APPEARED INTACT. THE ZERO-REFERENCE NUMBER WAS CORRECTLY ENTERED INTO THE ICP EXPRESS UNIT. THE NURSE WAS ADVISED THROUGH RE-SYNCHRONIZING BOTH MONITOR, CHANGED PATIENT CABLE AND MONITOR. HOWEVER, ALL TROUBLESHOOTING TECHNIQUES FAILED TO ELICIT A DIFFERENT OUTCOME. THEREFORE THE NURSE WAS ADVISED THAT IT WAS LIKELY A SENSOR ISSUE, EITHER DISLODGED OR DAMAGED IN A WAY NOT EASILY VISIBLE AND TO NOTIFY THE PHYSICIANS. THE SENSOR WAS REMOVED FOR INACCURATE READINGS AND WAS NOT REPLACED. THE PATIENT REMAINS IN SERIOUS, BUT STABLE CONDITION. CLINICAL QUESTIONNAIRE RECEIVED: IMPLANT LOCATION: PARENCHYMAL. HOSPITAL LOCATION OF IMPLANT: ICU. DID THE FAILURE OCCUR DURING PATIENT MOVEMENT? (I.E

  Patient problems: Insufficient Information

  MAUDE report 17551638 ↗
• MalfunctionMay 17, 2022Pressure Problem; Pressure Problem

  A FACILITY REPORTED A (B)(6) YEAR-OLD MALE PATIENT WITH TRAUMATIC BRAIN INJURY (SUBDURAL ACUTE HEMATOMA) WAS TRANSFERRED URGENTLY TO THE OPERATIVE ROOM, THE CATHETER WAS ZEROED WITH THE SKULL OPEN; THE MEASURE VALUE WAS 20 (NOT COMPATIBLE WITH PATIENT SITUATION). MEDICAL STAFF TOOK OFF THE CATHETER AND IN THE AIR THE VALUE MEASURED WAS STILL 20. THEY RE-ZEROED THE CATHETER, ZERO VALUE WAS DISPLAYED AND THEY TRIED TO IMPLANT AGAIN THE CATHETER, DISPLAYED MEASURE VALUE WAS -15. THEY PERFORMED A TAC BUT THE CATHETER WAS CORRECTLY IN PLACE. THE CATHETER IS STILL IN PLACE MEASURING -15 (NOT COMPATIBLE WITH PATIENT STATUS). THE CATHETER PLACEMENT IS INTRAPARENCHYMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14415008 ↗
• InjuryApr 19, 2022No Device Output; No Device Output

  A FACILITY REPORTED A CERELINK MICROSENSOR (ID 826852) WAS IMPLANTED IN THE OPERATIVE ROOM IN A (B)(6) FEMALE PATIENT AND CONNECTED TO THE ICP EXPRESS MONITOR. DURING THE FIRST 24 HOURS THE SENSOR WAS CORRECTLY WORKING AND THE ICP EXPRESS GAVE RELIABLE PRESSURE DATA. THEN THE PATIENT WAS TRANSFERRED TO THE ANGIOGRAPHIC ROOM. IN THE ANGIOGRAPHIC ROOM AND AFTER 24 HOURS FROM THE IMPLANTATION, THE MONITOR DISPLAYED THE FOLLOWING ERROR ¿SENSOR NOT DETECTED¿ AND IT DEFINITELY STOP WORKING THE SENSOR WAS REMOVED AND A NEW ONE WAS IMPLANTED AND CONNECTED TO A CERELINK MONITOR. ACTUALLY, THE NEW ONE IS WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141354 ↗
• InjuryMar 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED THAT AFTER THE PROBE INSERTION, THE CERELINK DISPLAYED NEGATIVE READINGS AND ERROR MESSAGE "SENSOR OR CABLE DAMAGE". THE SENSOR WAS REPLACED AND CONNECTED TO AN ICP EXPRESS MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13860420 ↗
• InjuryNov 2, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739941 ↗