CereLink™ 826854Recalls & reported problems
Integra Lifesciences Production Corporation · CereLink™ ICP Sensor Ventricular Catheter Kit with ICP Sensor · Class 2
All models of CereLink (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10381780520702), received between Mar 29, 2022 and May 8, 2026 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Deformation Due to Compressive Stress2
- No Device Output1
- Nonstandard Device1
- Obstruction of Flow1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, 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 ↗InjurySep 12, 2022Obstruction of Flow; Obstruction of Flow
A FACILITY REPORTED A CERELINK MONITOR GAVE ERROR THAT SENSOR OR PATIENT CABLE IS FAULTY. TROUBLESHOOTING WAS DONE AS PER IFU. DIFFERENT MONITOR WAS CONNECTED TO PROBE AND SAME ERROR PERSISTED. WHEN SURGEON REMOVED THE PROBE IN OPERATIVE ROOM IT BECAME APPARENT THAT THE VENTRICULAR DRAIN WAS OCCLUDED. A NEW SENSOR WAS INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15406885 ↗InjuryAug 17, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
A FACILITY REPORTED A CERELINK VENTRICULAR CATHETER SHOWED A KINK THEREFORE, NO MEASUREMENTS WERE POSSIBLE. THE CATHETER WAS EXPLANTED AND REPLACED ON (B)(6) 2022 TWO TO THREE DAYS AFTER IMPLANTATION. NO PATIENT SYMPTOMS DUE TO MALFUNCTION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15243365 ↗InjuryJun 1, 2022No Device Output; No Device Output
A FACILITY REPORTED A CERELINK ICP VENTRICULAR CATHETER WITH NO PRESSURE VALUE AFTER INSERTION AND MONITORING WAS NOT POSSIBLE. THE CATHETER WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14565607 ↗InjuryMay 9, 2022Output Problem; Output Problem
A FACILITY REPORTED NO VALUE OF A CERELINK ICP VENTRICULAR CATHETER. THE ICP MONITORING WAS DISCONTINUED, MORE MANIPULATION OF EVD SYSTEM. THE PATIENT IS BEING MONITORED WITH ANOTHER SYSTEM. THE CATHETER WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 14337830 ↗InjuryMar 29, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
A FACILITY REPORTED A CERELINK ICP VENTRICULAR CATHETER WAS KINKED AND THE SENSOR COULD NOT GIVE MEASUREMENTS. THE SENSOR WAS IMPLANTED ON (B)(6) 2022, EXPLANTED AND REPLACED ON (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13938920 ↗
Other Device, monitoring, intracranial pressure devices
- Exacta™ 27666Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall124 reports
- Exacta™ 46705Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall117 reports
- CereLink™ 826850Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 recall2 deaths112 reports
- Duet® 46913Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall58 reports
- CereLink™ 826851Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure96 reports
- Becker® 26040Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall46 reports
- Becker® 46129Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall29 reports
- Codman Microsensor® 826631Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure75 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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