CERELINK 826850Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704075448), received between Mar 23, 2022 and Jul 19, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A CERELINK SENSOR (ID (B)(4)) WAS PLACED ON (B)(6) 2021. THE SENSOR CONTINUOUSLY MONITORING A HIGH ICP AND NOT ACCURATE. THE ICP MONITORING WAS USED FOR RIGHT FRONTAL TEMPORAL CYSTIC MASS DRAINAGE AND WAS PLACED IN THE PATIENT FOR 68.5 HOURS. THE SENSOR WAS REMOVED ON (B)(6) 2021. IT IS UNKNOWN IF THE SENSOR WAS REMOVED DUE TO INACCURATE READINGS OR MONITORING NOT NEEDED ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15058532 ↗
• MalfunctionMar 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A FACILITY REPORTED A PATIENT HAD ICP READINGS AS LOW AS -10 FROM A CERELINK MICROSENSOR; PATIENT RECEIVED ICP MONITOR FOR HEADACHES OF UNKNOWN ETIOLOGY. ACCOUNT MANAGER AND CLINICAL SPECIALIST WERE BOTH PRESENT FOR INSERTION, WHICH WENT VERY WELL. PATIENT HAD ICP VALUE IN THE NORMAL RANGE OF 4 ¿ 6. PATIENT WAS DISCONNECTED PRIOR TO TRANSFER TO BED FROM THE OR TABLE. PATIENT WAS RECONNECTED ONCE IN PACU. READINGS WERE STABLE IN THE 4-6MMHG. INSTRUCTED PACU RNS TO DISCONNECT PATIENT FOR TRANSPORT TO THE ICU. ICP VALUE WAS 2 AT TIME OF DISCONNECTION, LATER VALUES WERE -3. BEDSIDE RN SAID PATIENT WAS CLINICALLY INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13863937 ↗

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