Codman Microsensor® 826633Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN MICROSENSOR® Ventricular Catheter Kit for Intraventricular Procedure · Class 2
Quick summary
This Codman Microsensor ventricular catheter kit is used to monitor pressure inside the brain during and after surgery. The 46 reports mostly describe fluid or blood leaking from the sensor's connector, unreliable or erratic pressure readings, and parts breaking or connectors that would not lock tight, sometimes forcing the sensor to be removed and the operation to be delayed. Twenty reports describe injuries and none describe deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10381780520436), received between Nov 2, 2021 and Jan 5, 2026 — classified as 20 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak11
- Incorrect, Inadequate or Imprecise Result or Readings7
- Leak/Splash5
- Break4
- Connection Problem3
- Mechanical Problem3
- Appropriate Device Problem Term/Code Not Available2
- Failure to Read Input Signal2
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Insufficient Information10
- Cerebrospinal Fluid Leakage8
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2026Leak/Splash
A FACILITY REPORTED CSF LEAK FROM THE WHITE CONNECTOR DURING A PROCEDURE. THE SENSOR WAS RETRIEVED AND STOPPED MONITORING. NO PATIENT INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23955883 ↗MalfunctionDec 5, 2025Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED THE PART OF MICROSENSOR (ID 826633) WHICH WAS CONNECTING WITH THE CABLE WITH CEREBROSPINAL FLUID (CSF) LEAK. THE EVENT HAPPENED DURING A PROCEDURE BEFORE THE IMPLANTATION SITE CLOSURE AND IT WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY REPORTED AND THE EVENT LED TO 10 MINUTES SURGICAL DELAY.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 23733035 ↗MalfunctionSep 12, 2025Mechanical Problem; Mechanical Problem
A FACILITY REPORTED THE LUER-FITTING OF AN ICP MICROSENSOR COULD NOT BE FIXED TIGHTLY. NO PATIENT INJURY/CONSEQUENCES. THE EVENT LED TO 15 MINUTES SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23037628 ↗InjuryMay 28, 2025Air/Gas in Device; Air/Gas in Device
InjuryMay 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPORTED A MICROSENSOR (ID: 826633) WAS IMPLANTED ON (B)(6) 2025. TWO DAYS AFTER THE PROCEDURE, THE MICROSENSOR DISLODGED, THEREFORE, IT WAS RETRIEVED. THE SENSOR WAS NOT REPLACED, AND THERE IS NO INFORMATION ON WHETHER THE MONITORING STOPPED DUE TO THE PRODUCT PROBLEM OR IF MONITORING WAS NO LONGER NECESSARY. THE PATIENT'S STATUS IS STABLE. THE MONITOR AND CABLE USED WERE ICP EXPRESS, 220 VOLT (ID: 826635) AND ICP EXPRESS CABLE (ID: 826636).
Patient problems: Insufficient Information
MAUDE report 22013043 ↗InjuryMar 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
InjuryFeb 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED AN ICP SENSOR CATHETER KIT (ID 826633) WAS IMPLANTED AND FOUR HOURS AFTER THE PROCEDURE, THE PATIENT WAS SENT BACK TO WARD, WHEN THE PHYSICIAN TRIED TO RECONNECT THE MICROSENSOR, THE ICP MONITOR SHOWED FLUCTUATING READINGS FROM -5MMHG TO 145MMHG. THEREFORE, THE PHYSICIAN RETRIEVED THE MICROSENSOR AND STOP MONITORING.
Patient problems: Insufficient Information
MAUDE report 21384771 ↗MalfunctionJan 7, 2025Leak/Splash; Leak/Splash
A FACILITY REPORTED THAT DURING A PROCEDURE, THE PHYSICIAN COULD NOT LOCK THE FEMALE CONNECTOR INTO THE ADAPTER OF AN ICP SENSOR CATHETER KIT (ID 826633), IT WAS IDENTIFIED THAT THE THREADS WERE SLIGHTLY WARPED CAUSING A FAILURE TO COMPLETELY LOCK THE LURE CONNECTION AND CSF WAS LEAKING OUT FROM THE LURE CONNECTOR. THEN THE PHYSICIAN CHANGED WITH THE SECOND NEW 826633, WHICH WAS WITH THE SAME PROBLEM. AFTER THAT, THE PHYSICIAN CHANGED WITH THE THIRD NEW 826633 AND TESTED IT OUTSIDE PATIENT, IT STILL COULD NOT BE LOCKED. FINALLY, THE PHYSICIAN CHANGED WITH THE FORTH 826633 INTO THE PATIENT WHICH COULD BE USED. NO PATIENT INJURY/CONSEQUENCES REPORTED AND THE EVENT LED TO 15 MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21093963 ↗InjuryJan 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED A MICROSENSOR (ID 826633) WAS IMPLANTED ON (B)(6) 2024. DURING THE PROCEDURE, THE SENSOR COULD BE ZEROED NORMALLY, BUT WHEN THE PATIENT WAS SENT BACK AND RECONNECTED THE SENSOR TO THE ICP MONITOR IT SHOWED P-0. THEREFORE, THE SENSOR WAS REMOVED AND MONITORING STOPPED ON (B)(6) 2024. THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS. ACCORDING TO INFORMATION PROVIDED, THE PATIENT CURRENT STATUS IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21066602 ↗MalfunctionDec 17, 2024Break; Break
InjuryOct 4, 2024Break; Break
A FACILITY REPORTED A MICROSENSOR (ID 826633) WAS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, WHEN THE PHYSICIAN WAS RETRIEVING THE MICROSENSOR, THE MICROSENSOR WAS BROKEN AND REMAINED PART OF THE MICROSENSOR WAS LEFT IN PATIENT. THEN THE PHYSICIAN HAD TO REMOVE THE SUTURE AND RETRIEVED THE REMAINED PART OUT OF THE PATIENT. THE MONITOR AND CABLE USED WERE ICP EXPRESS MONITOR, (ID 826635) AND ICP EXPRESS CABLE (ID 826636).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20369199 ↗InjuryAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR (ID 826633) WAS IMPLANTED ON (B)(6) 2024. AFTER THE PROCEDURE, THE PHYSICIAN FOUND THAT HE COULD NOT LOCK THE FEMALE CONNECTOR INTO THE ADAPTER, IT WAS IDENTIFIED THAT THE THREADS WERE SLIGHTLY WARPED CAUSING A FAILURE TO COMPLETELY LOCK THE LURE CONNECTOR. THEREFORE, THE CSF WAS LEAKING FROM THE LURE CONNECTOR, THE PHYSICIAN TRIED TO USE THE TAPE TO WRAP THE LURE CONNECTOR. THREE DAYS LATER, THERE WAS STILL MINIMAL CSF LEAKING. ON (B)(6) 2024, THE PHYSICIAN RETRIEVED THE MICROSENSOR AND STOP MONITORING. THE PATIENT IS STABLE.
Patient problems: Insufficient Information
MAUDE report 20042638 ↗InjuryJul 12, 2024Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR (ID 826633) COULD NOT BE SCREWED TIGHTLY AND WAS LEAKING CEREBROSPINAL FLUID (CSF) AT THE END OF THE CATHETER'S BLUE CAP AFTER IT WAS IMPLANTED ON (B)(6) 2024. THE PHYSICIAN REMOVED THE SENSOR AND STOPPED MONITORING ON THE SAME DAY. IT WAS ESTIMATED THAT THERE WAS A MODERATE AMOUNT OF CSF LEAKAGE. THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS DUE TO CSF LEAKAGE AND IS CURRENTLY STABLE.
Patient problems: Insufficient Information
MAUDE report 19734463 ↗InjuryJul 12, 2024Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR (ID 826633) WAS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, THE PHYSICIAN FOUND THAT THE BLUE CAP AT THE END OF THE CATHETER WAS LEAKING CEREBROSPINAL FLUID (CSF) AND THE PHYSICIAN USED GAUZE TO WRAP WHERE WAS LEAKING CSF. ON (B)(6) 2024, IT WAS STILL LEAKING CSF AT THE BLUE CAP. THEN THE PHYSICIAN RETRIEVED THE DEVICE AND STOP MONITORING. THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS DUE TO CSF LEAKAGE AND IS CURRENTLY STABLE.
Patient problems: Insufficient Information
MAUDE report 19731516 ↗InjuryJul 3, 2024Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
A FACILITY REPORTED A PHYSICIAN FOUND A SPLIT ON THE SILICONE TUBE OF A MICROSENSOR (ID 826633) AND THERE WAS CEREBROSPINAL FLUID (CSF) LEAKING OUT FROM THE SPLIT. THE SENSOR WAS IMPLANTED ON (B)(6) 2024 AND WAS USED ALONG WITH THE ICP MONITOR 826635 AND CABLE 826636. THE PHYSICIAN RETRIEVED THE DEVICE AND STOP THE MONITORING. THE PATIENT IS STABLE AND DID NOT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO DEVICE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19670877 ↗InjuryJun 26, 2024Imprecise or Erratic Results; Imprecise or Erratic Results
A FACILITY REPORTED THAT A MICROSENSOR (ID 826633) COULD NOT SHOWED THE NORMAL READINGS. THIS HAPPENED AFTER THE PATIENT WAS SENT BACK TO WARD. THE READING WAS INACCURATELY POSITIVE AND SOMETIMES NEGATIVE, THEN THE INCREASED INTRACRANIAL PRESSURE (ICP) READING BECOME -99MMHG. THEREFORE, THE PHYSICIAN STOP MONITORING AND REMOVED THE SENSOR ON (B)(6) 2024. THE MONITOR USED WAS ICP EXPRESS, 220 VOLT (ID 826635) AND THE CABLE USED WAS ICP EXPRESS CABLE (ID 826636).
Patient problems: Insufficient Information
MAUDE report 19621043 ↗InjuryJun 26, 2024Fluid/Blood Leak; Fluid/Blood Leak
MalfunctionMay 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
A FACILITY REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE BLUE END OF LUER-LOCK OF THE MICROSENSOR COULD NOT BE SCREWED TIGHTLY WITH CSF FLOWING OUT. THEREFORE, THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT CONSEQUENCES, NO SURGICAL DELAY DUE TO PRODUCT PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19234560 ↗InjuryFeb 20, 2024Mechanical Problem; Mechanical Problem
A FACILITY REPORTED A MICROSENSOR (ID 826633) WAS IMPLANTED ON (B)(6) 2023 WITHOUT ANY ISSUE. TWO DAYS AFTER THE PROCEDURE THE PHYSICIAN FOUND THAT THE BLUE END OF LUER-LOCK OF THE MICROSENSOR COULD NOT BE SCREWED TIGHTLY. THEREFORE, THE PHYSICIAN RETRIEVED THE MICROSENSOR AND STOP MONITORING ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 18742458 ↗MalfunctionOct 5, 2023Failure to Read Input Signal; Failure to Read Input Signal
A FACILITY REPORTED A MICROSENSOR (ID 826633) SHOWED NO READINGS DURING THE IMPLANTATION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. ISSUE DETECTED BEFORE IMPLANTATION SITE CLOSURE, AND THE EVENT LED TO 15 MINUTES SURGICAL DELAY. THE MONITOR USED WAS ICP EXPRESS, 220 VOLT (ID 826635) AND THE CABLE USED WAS ICP EXPRESS CABLE (ID 826636).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17878376 ↗MalfunctionSep 13, 2023Break; Break
A FACILITY REPORTED A MICROSENSOR (ID 826633) BROKE AFTER UNPACKING THE DEVICE. NO BROKEN PART FELL INTO SURGICAL SITE AND ALL BROKEN PARTS WERE RECOVERED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. THE MONITOR USED WAS ICP EXPRESS, 220 VOLT (ID 826635) AND THE CABLE USED WAS ICP EXPRESS CABLE (ID 826636).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17741188 ↗MalfunctionAug 22, 2023Mechanical Problem; Mechanical Problem
A FACILITY REPORTED THE LUER-FITTING OF AN ICP SENSOR CANNOT BE FIXED DURING PROCEDURE, BEFORE IMPLANTATION SITE CLOSURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT CONSEQUENCES REPORTED AND THE EVENT LED TO 15 MINUTES SURGICAL DELAY. THE MONITOR USED WAS ICP EXPRESS, 220 VOLT (ID (B)(4).) AND THE CABLE USED WAS ICP EXPRESS CABLE (ID (B)(4).).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17596607 ↗MalfunctionAug 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPORTED A MICROSENSOR CATHETER KIT (ID 826633) WAS FOUND BROKEN. THE EVENT HAPPENED BEFORE IMPLANTATION. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. BASED ON INFORMATION PROVIDED, NO BROKEN PART FELL INTO SURGICAL SITE AND ALL BROKEN PARTS WERE RECOVERED. THE MONITOR USED WAS ICP EXPRESS, 220 VOLT (ID 826635) AND THE CABLE USED WAS ICP EXPRESS CABLE (ID 826636).
Patient problems: Insufficient Information
MAUDE report 17586422 ↗MalfunctionAug 8, 2023No Device Output; No Device Output
InjuryJul 26, 2023Leak/Splash; Leak/Splash
A FACILITY REPORTED AN ICP SENSOR (ID 826633) WAS IMPLANTED ON (B)(6) 2023 AND ONE DAY AFTER PROCEDURE, THE PHYSICIAN FOUND THAT THERE WAS CEREBROSPINAL FLUID (CSF) LEAKING OUT FROM THE LUER-FITTING OF THE MICROSENSOR (ID 826633). THE PATIENT DID NOT SHOW ANY SIGNS AND SYMPTOMS DUE TO CSF LEAK. THE MICROSENSOR WAS REMOVED ON (B)(6) 2023 AND WAS NOT REPLACED. THE PATIENT IS STABLE.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 17397359 ↗
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- CereLink™ 826851Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure96 reports
- Becker® 46129Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall29 reports
- Codman Microsensor® 826631Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure75 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.