CODMAN CERELINK 826820Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704075622), received between Apr 13, 2022 and Dec 27, 2023 — classified as 3 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 (K183406); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2023Output Problem; Output Problem

  A FACILITY REPORTED: "WHEN USING THE CERELINK MONITOR, THE ERROR SIGN FOR THE CABLE APPEARED. THE CLIENT HAD TO CHANGE TO THE ICP EXPRESS SYSTEM." ADDITIONAL INFORMATION RECEIVED: COULD YOU PLEASE PROVIDE MORE DETAILS ABOUT DYSFUNCTION (NEGATIVE ICP VALUES BEFORE ERROR MESSAGE)? ANSWER : AFTER THE IMPLANT OF THE SENSOR, WHEN CONNECTING THE CABLE TO THE SENSOR THE REPORTED ERROR MESSAGE CAME OUT. WILL THE MONITOR BE RETURNED TO INTEGRA FOR ANALYSIS? ANSWER : NO. WAS THE NEW OR OLD CERELINK CABLE USED DURING THE DYSFUNCTION? ANSWER : NEW (NO ECG CONNECTION IN THE OR DUE TO THE POSITIONING OF THE PATIENT) WAS THE MONITOR ALREADY REWORKED? ANSWER : YES. AFTER HOW MANY TIME OF USE THE DYSFUNCTION APPEARED? ANSWER : IMMEDIATELY. WERE THERE ANY CONSEQUENCES FOR THE PATIENT (AS INJURY)? ANSWER : NO. WERE THERE ANY LATE MEDICAL ACTIONS DUE TO DYSFUNCTION? ANSWER : 15MINS CA. WAS THE PATIENT AN ELDERLY PERSON, AN ADULT, A CHILD OR A BABY? ANSWER : ADULT (CA 65YO). WHAT ARE PRODUCT REFERENCE, LOT AND SERIAL NUMBER OF SENSOR? ANSWER : (B)(6) (NO LOT AVAILABLE). WHERE WAS THE SENSOR IMPLANTED (EX : PARENCHYMA) ? ANSWER : PARENCHYMA. WAS THE INTEGRA/CODMAN ICP MONITOR CONNECTED TO A PATIENT MONI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399252 ↗
• MalfunctionDec 22, 2023Incorrect, 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 18383947 ↗
• MalfunctionApr 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THIS IS 2 OF 2 REPORTS. OTHER MFG REPORT NO.: 3013886523-2022-00145. IT WAS REPORTED THAT A BRAND NEW CERELINK BASIC KIT WAS USED WITH DEMONSTRATION MONITOR. IT WORKED FOR A FEW DEMONSTRATIONS BUT NOTICED THAT THE MONITOR HAD SLOWLY STARTED TO INCREASE IN ICP TO THE 40¿S. THE SENSOR WAS JUST SITTING ON THE TABLE, WITH NO PRESSURE ON IT AT ALL. THEN, IT STARTED TO DROP AND GO NEGATIVE, UNTIL CABLE/SENSOR FAILURE WAS NOTED. EVERYTHING WAS UNPLUGGED, WAITED OVER 20 MINUTES AND WHEN PLUGGED BACK IN THE SENSOR, THE CABLE/SENSOR FAILURE AGAIN PROMPTED. NEXT, THEY DISCONNECTED EVERYTHING, PLUGGED IN THE SENSOR AND TRIED TO ZERO IT AGAIN. IT GAVE THE RED LIGHT, STATING THEY COULD NOT ZERO IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14101940 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183406. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2020 · Sep 12, 2019 · Open, Classified
  Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitorin