CERELINK 826851Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886704075431), received between Dec 2, 2021 and Aug 9, 2024 — classified as 6 injuries, 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K173192); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  8 OF 12 REPORTS (DIFFERENT PATIENTS, SAME FAILURE). OTHER MFG REPORT NUMBERS: 3013886523-2024-00228, 3013886523-2024-00229, 3013886523-2024-00230, 3013886523-2024-00231, 3013886523-2024-00232, 3013886523-2024-00233, 3013886523-2024-00234, 3013886523-2024-00236, 3013886523-2024-00237, 3013886523-2024-00238, 3013886523-2024-00239. CASE 4: A FACILITY REPORTED A DIRECTLINK MODULE (ID 826828) WITH INCONSISTENT VALUES. THE MODULE WAS USED WITH CERELINK SENSOR (ID 826851). THE SENSOR WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950168 ↗
• InjuryAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  4 OF 12 REPORTS (DIFFERENT PATIENTS, SAME FAILURE). OTHER MFG REPORT NUMBERS: 3013886523-2024-00228, 3013886523-2024-00229, 3013886523-2024-00230, 3013886523-2024-00232, 3013886523-2024-00233, 3013886523-2024-00234, 3013886523-2024-00235, 3013886523-2024-00236, 3013886523-2024-00237, 3013886523-2024-00238, 3013886523-2024-00239. CASE 2: A FACILITY REPORTED A DIRECTLINK MODULE (ID 826828) WITH INCONSISTENT VALUES. THE MODULE WAS USED WITH CERELINK SENSOR (ID 826851). THE SENSOR WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950165 ↗
• InjuryAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  8 OF 12 REPORTS (DIFFERENT PATIENTS, SAME FAILURE). OTHER MFG REPORT NUMBERS: 3013886523-2024-00228, 3013886523-2024-00229, 3013886523-2024-00230, 3013886523-2024-00231, 3013886523-2024-00232, 3013886523-2024-00233, 3013886523-2024-00234, 3013886523-2024-00235, 3013886523-2024-00236, 3013886523-2024-00238, 3013886523-2024-00239. CASE 5: A FACILITY REPORTED A DIRECTLINK MODULE (ID 826828) WITH INCONSISTENT VALUES. THE MODULE WAS USED WITH CERELINK SENSOR (ID 826851). THE SENSOR WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950095 ↗
• MalfunctionJun 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: A FACILITY REPORTED A CERELINK SENSOR (ID 826851) WAS PLACED IN THE PATIENT ON (B)(6) 2022 FOR PSEUDOTUMOR EVALUATION. IN THE EVENING IT WAS REPORTED THAT THE ICPS WERE -3. THE NURSE STATED THAT SHE FELT THERE WAS NO CLINICAL REASON FOR THE NEGATIVE NUMBERS. THE NURSE DID REPORT THAT THE PATIENT WAS SITTING UP IN BED, ON HER PHONE, IN NO DISTRESS. THE PHYSICIAN ASSISTANT ALSO STATED THAT, " IT COULD BE ATTRIBUTED TO THE PATIENT SITTING UP IN BED, BUT DID FEEL IT WAS A LARGE DISCREPANCY." THE CERELINK MONITOR HAD A GOOD AND RESPONSIVE WAVEFORM, HOWEVER, THERE WAS A CONCERN THAT THE INFORMATION THE MONITOR WAS GIVING THE PROVIDERS WASN'T VALID. IT IS UNKNOWN IF THE SENSOR WAS REMOVED OR IF THE PATIENT WAS STILL MONITORED. CLINICAL QUESTIONNAIRE PROVIDED BY THE CUSTOMER: TIME/DATE OF FAILURE: (B)(6) 2022, REPORTED AT 1919. DESCRIPTION OF THE FAILURE: "PT HAD BOLT PLACED IN OR IN THE LATE AFTERNOON. THE MONITOR WAS ON BATTERY POWER UNTIL THE PATIENT WENT TO THE ICU WHEN IT WAS PLUGGED IN AND CONNECTED TO THE PATIENT MONITOR. ICP AT PLACEMENT WAS 12. NIGHT RN CALLED CLINICAL SPECIALIST AT 1919 REGARDING ICP BEING -3. NIGHT RN DID NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634281 ↗
• InjuryMay 10, 2022Failure to Zero; Failure to Zero

  THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBER: 3013886523-2021-00537, 3013886523-2021-00538. A FACILITY REPORTED A PATIENT HAD A CERELINK SENSOR PLACED WITH GOOD WAVEFORM AND ICP VALUE. 25 TO 30 MINUTES LATER, THE SURGEON RECEIVED A CALL THAT THE ICP READING WAS -32. THEY CHANGED THE CABLES AND SHOWED A MESSAGE OF FAILED SENSOR. THE MONITOR READ OCCASIONALLY THEN WORKED AGAIN. IT STOPPED WORKING AGAIN AT 11PM. THE SURGEON DECIDED TO WAIT UNTIL MORNING BUT STILL DID NOT WORK. THEY TOOK THE PATIENT BACK TO THE OPERATIVE ROOM TO HAVE IT REPLACED. A SECOND SENSOR WOULD NOT ZERO WITH THE MONITOR WHICH STATED FAILED SENSOR AND IT WAS REPLACED WITH ANOTHER SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14346306 ↗
• MalfunctionApr 12, 2022Output Problem; Output Problem

  WHILE DEMONSTRATING HOW TO USE THE CERELINK MONITOR AN ERROR MESSAGE APPEARED SAYING THAT THE SYSTEM DETECTED A PROBLEM EITHER WITH THE EXTENSION CABLE OR SENSOR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14085477 ↗
• InjuryDec 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  A FACILITY REPORTED THE MICROSENSOR REGISTERED SENSOR FAILURE. THE SENSOR WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 12920774 ↗
• InjuryDec 2, 2021Low Readings; Low Readings

  A FACILITY REPORTED A PATIENT HAD A BOLT PLACED WITH GOOD WAVEFORM AND ICP VALUE. 25-30 MINUTES LATER, THE SURGEON RECEIVED A CALL THAT THE ICP READING WAS -32. THEY CHANGED THE CABLES AND SHOWED A MESSAGE OF FAILED SENSOR. THE MONITOR READ OCCASIONALLY THEN WORKED AGAIN. IT STOPPED WORKING AGAIN AT 11PM. THE SURGEON DECIDED TO WAIT UNTIL MORNING BUT STILL DID NOT WORK. THEY TOOK THE PATIENT BACK TO THE OR TO HAVE IT REPLACED. A SECOND SENSOR WOULD NOT ZERO WITH THE MONITOR WHICH STATED FAILED SENSOR AND IT WAS REPLACED WITH ANOTHER SENSOR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12918545 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173192. One submission often covers many models, so check the product and lot details in each record.

• Z-1037-2026 · Dec 12, 2025 · Open, Classified
  Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needl