CODMAN® MICROSENSOR® 826653Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® MICROSENSOR® Ventricular Catheter Kit with ICP Sensor Contains (1) Microsensor Ventricular Catheter, (1) Tunneling Trocar, (1) Catheter Anchoring Clip · Class 2
Quick summary
This Codman Microsensor ventricular catheter kit is used to monitor pressure inside the brain during and after surgery. The 68 reports mostly describe cerebrospinal fluid leaking from the catheter where the stiffening rod was removed, plus catheters that broke during implantation or stopped sending readings, sometimes requiring removal and repeat surgery. Reports mention 48 injuries and no deaths, with 20 malfunctions. There are no recalls for 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
- 68
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10381780520566), received between Nov 17, 2021 and Jan 7, 2026 — classified as 48 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (29 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 Leak29
- Leak/Splash9
- Failure to Read Input Signal6
- Break5
- Output Problem4
- Failure to Zero3
- No Device Output3
- Incorrect, Inadequate or Imprecise Result or Readings2
Patient problems
- Cerebrospinal Fluid Leakage32
- No Clinical Signs, Symptoms or Conditions27
- Insufficient Information7
- Failure of Implant1
- Fever1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2026Leak/Splash
MalfunctionSep 12, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
A FACILITY REPORTED THE STERILE PACKAGE OF A MICROSENSOR VENTRICULAR CATHETER KIT (ID 826653) WAS BROKEN. PRODUCT WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY/CONSEQUENCES AND THE EVENT DID NOT LED TO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23037627 ↗MalfunctionAug 28, 2025Break; Break
A FACILITY REPORTED THAT DURING IMPLANTATION PROCEDURE, THE MICRORSENSOR (ID 826653) BROKE AFTER SLIGHTLY BEING PULLED. THE PHYSICIAN SAID THIS MICROSENSOR WAS TOO FRAGILE TO IMPLANT INTO THE PATIENT. THEN THE PHYSICIAN RETRIEVED THE DEVICE AND STOP MONITORING. THE EVENT LED TO 15 MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911715 ↗InjuryAug 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR (ID (B)(6)) WAS IMPLANTED ON (B)(6) 2025. ON THE SAME DAY, MODERATE CEREBROSPINAL FLUID (CSF) LEAKAGE WAS OBSERVED FROM THE SIDE HOLE OF THE CATHETER WHERE THE STYLET HAD BEEN REMOVED. THE PHYSICIAN SUBSEQUENTLY RETRIEVED THE CATHETER AND DISCONTINUED MONITORING DUE TO SENSOR FAILURE ON (B)(6) 2025. THE MONITOR USED WAS AN ICP EXPRESS, 220 VOLT (ID (B)(6)), AND THE CABLE USED WAS AN ICP EXPRESS CABLE (ID (B)(6)). THERE IS NO INFORMATION AVAILABLE INDICATING WHETHER THE PATIENT EXPERIENCED ANY SIGNS OR SYMPTOMS RELATED TO THE CSF LEAKAGE. THE PATIENT IS STABLE.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 22809220 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED THAT DURING A PROCEDURE, AFTER IMPLANTING A MICROSENSOR (ID: 826653), IT WAS LEAKING CEREBROSPINAL FLUID (CSF). THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY REPORTED AND THE EVENT LED TO 10 MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22072429 ↗MalfunctionMay 8, 2025Leak/Splash; Leak/Splash
A FACILITY REPORTED A MICROSENSOR (B)(6) WAS LEAKING CSF FROM THE CATHETER WHERE STYLET WAS PULLED OUT. THEN THE PHYSICIAN USED STERILE BANDAGES TO WRAP THE CATHETER TO PREVENT FURTHER LEAKAGE. THE EVENT HAPPENED DURING PROCEDURE. NO PATIENT INJURY, NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21985698 ↗MalfunctionMar 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS LEAKING FROM THE CATHETER WHERE STYLET WAS PULLED OUT. THE EVENT HAPPENED BEFORE IMPLANTATION SITE CLOSURE AND NO DELAY WAS NOTED. THE PHYSICIAN RETRIEVED THE CATHETER AND STOPPED MONITORING.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 21636392 ↗InjuryFeb 27, 2025Break; Break
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS IMPLANTED ON (B)(6) 2025. THE MICROSENSOR WAS BROKEN WHEN THE PATIENT RETURNED TO THE WARD. THEREFORE, THE PATIENT WAS SENT BACK TO RECEIVE THE REVISION PROCEDURE TO REMOVE AND REPLACE THE SENSOR ON (B)(6) 2025. ALL THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS DUE TO THE DEVICE ISSUE AND IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21483102 ↗InjuryOct 4, 2024Leak/Splash; Leak/Splash
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS IMPLANTED ON (B)(6) 2024 DUE TO CEREBRAL HEMORRHAGE. TWO HOURS AFTER THE PROCEDURE THE PHYSICIAN FOUND THAT THERE WAS CSF LEAKING AT THE SLIT OF THE CATHETER. THEN THE PHYSICIAN RETRIEVED THE DEVICE AND STOP MONITORING.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 20369182 ↗MalfunctionOct 4, 2024Leak/Splash; Leak/Splash
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS IMPLANTED ON (B)(6) 2024. THE PHYSICIAN WAS ABOUT TO CLOSE THE IMPLANTATION SITE, WHILE HE FOUND THAT THERE WAS CSF LEAKING AT THE SLIT OF THE CATHETER. THEN THE PHYSICIAN RETRIEVED THE DEVICE AND STOP MONITORING. THE EVENT LED TO 20 MINUTES SURGICAL DELAY. THE ESTIMATED AMOUNT OF CSF LEAKAGE WAS MINIMAL. THE MONITOR AND CABLE USED WERE ICP EXPRESS MONITOR (ID 826635) AND ICP EXPRESS CABLE (ID 826636).
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 20369181 ↗InjurySep 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS IMPLANTED ON (B)(6) 2024. EARLY MORNING ON (B)(6) 2023, THE MICROSENSOR WAS LEAKING A MINIMAL AMOUNT OF CEREBROSPINAL FLUID (CSF) FROM THE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS DUE TO THE DEVICE ISSUE. LATE ON (B)(6) 2024, THE MICROSENSOR WAS REMOVED AND REPLACED WITH A NEW ID 826653. THE PATIENT'S CONDITION IS STABLE.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 20150631 ↗InjuryAug 28, 2024Leak/Splash; Leak/Splash
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS IMPLANTED. ONE HOUR AFTER THE PROCEDURE, THE MICROSENSOR WAS LEAKING CSF FROM THE CATHETER. THEN, THE PHYSICIAN USED ADHESIVE PLASTERS TO WRAP THE MICROSENSOR WHILE THERE WAS STILL CSF LEAKING FROM THE CATHETER. THEREFORE, THE SENSOR WAS RETRIEVED IT ON (B)(6) 2024. PATIENT STATUS WAS REPORTED AS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20086832 ↗MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR (826653) WAS IMPLANTED ON (B)(6) 2024. ONE DAY AFTER THE IMPLANTATION, A MINIMAL CEREBROSPINAL FLUID (CSF) LEAK WAS OBSERVED FROM THE CATHETER WHERE STYLET WAS PULLED OUT. THEREFORE, A GAUZE WAS USED TO WRAP THE SENSOR. IT WAS RETRIEVED ON (B)(6) 2024 AND WAS NOT REPLACED. THE PATIENT DID NOT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO DEVICE ISSUE AND IS CURRENTLY STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20044240 ↗MalfunctionAug 22, 2024Communication or Transmission Problem; Communication or Transmission Problem
InjuryJul 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, A MINIMAL AMOUNT OF CEREBROSPINAL FLUID (CSF) LEAKAGE WAS DISCOVERED IN THE CONNECTOR. THEREFORE, THE PHYSICIAN REMOVED THE SENSOR AND STOPPED MONITORING. THE SENSOR WAS USED WITH CP EXPRESS MONITOR (ID 826635) AND ICP EXPRESS CABLE (ID 826636).
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 19780345 ↗InjuryJul 12, 2024Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS BROKEN AT THE END OF THE CATHETER AND WAS LEAKING CEREBROSPINAL FLUID (CSF) DURING THE PROCEDURE. THE EVENT HAPPENED AFTER IMPLANTATION SITE CLOSURE AND NO DELAY WAS NOTED. THE PHYSICIAN REMOVED THE DEVICE AND REPLACED IT WITH A NEW ONE TO COMPLETE THE PROCEDURE. AN X-RAY WAS NOT NECESSARY SINCE ALL BROKEN PARTS HAD BEEN RECOVERED. THE PATIENT IS CURRENTLY STABLE.
Patient problems: Insufficient Information
MAUDE report 19731520 ↗MalfunctionJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS IMPLANTED AND WAS LEAKING CEREBROSPINAL FLUID (CSF). THE ISSUE WAS DETECTED DURING PROCEDURE, BEFORE IMPLANTATION SITE CLOSURE AND THE EVENT LED TO 15 MINUTES SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. THE PATIENT IS IN STABLE CONDITION. THE MICROSENSOR WAS USED WITH ICP EXPRESS MONITOR (ID 826635) AND ICP EXPRESS CABLE (ID 826635).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19669880 ↗InjuryMay 9, 2024No Device Output; No Device Output
InjuryMar 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR (B)(6) WAS IMPLANTED ON (B)(6) 2024 AT 6:00PM, AND AROUND 10:30 PM, THE MICROSENSOR WAS FOUND LEAKING A MODERATE AMOUNT OF CEREBROSPINAL FLUID (CSF), THE SURGICAL DRESSING WAS WET. ON JANUARY 10, 2024, THE PHYSICIAN FOUND THAT THERE WAS NO MORE CEREBROSPINAL FLUID (CSF) LEAKING, AND RETRIEVED THE MICROSENSOR. THE SENSOR WAS NOT REPLACED AND THE PATIENT DID NOT EXPERIENCE ANY SIGNS AND SYMPTOMS DUE TO CSF LEAKING. THE PATIENT IS IN GOOD CONDITION. THE MONITOR USED WAS ICP EXPRESS MONITOR (B)(6), CABLE USED WAS ICP EXPRESS CABLE (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18838848 ↗InjuryNov 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED THAT DURING PRE- TESTING, A MICROSENSOR (ID 826653) COULD BE ZEROED NORMALLY AND IT COULD MONITOR THE ICP READINGS NORMALLY DURING THE PROCEDURE. HOWEVER, A WHILE AFTER THE PATIENT WAS SENT BACK TO WARD, THE ICP MONITOR SHOWED"P-0" REPEATEDLY. THEN THE PHYSICIAN CHANGED WITH ANOTHER CABLE AND ICP MONITOR TO RECONNECT WITH THE MICROSENSOR, IT STILL SHOWED"P-0". THEREFORE, THE PROBLEM WAS WITH THE MICROSENSOR. THE PHYSICIAN RETRIEVED THE MICROSENSOR AND STOPPED MONITORING. THE MICROSENSOR WAS USED ALONG WITH ICP MONITOR (ID 826653) AND ICP CABLE (ID 826636).
Patient problems: Insufficient Information
MAUDE report 18192579 ↗InjuryNov 22, 2023Failure to Read Input Signal; Failure to Read Input Signal
InjuryOct 17, 2023Failure to Read Input Signal; Failure to Read Input Signal
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS IMPLANTED IN JULY 29 AND IN MAY 8, THE HOSPITAL REPORTED A MALFUNCTION OF THE MONITOR. DURING THIS PERIOD, THE PATIENT UNDERWENT A SECOND SURGICAL INTERVENTION. IT WAS IDENTIFIED THAT THE MONITOR WAS WORKING, HOWEVER, IT DID NOT RECOGNIZE THE IMPLANTED TRANSDUCER. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS
Patient problems: Insufficient Information
MAUDE report 17951001 ↗InjuryOct 12, 2023Failure to Read Input Signal; Failure to Read Input Signal
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS IMPLANTED ON (B)(6), 2023. THE SENSOR WAS WORKING NORMALLY DURING THE PROCEDURE, HOWEVER, WHEN THE PATIENT WAS SENT BACK TO THE WARD, THE ICP MONITOR COULD NOT DETECT THE MICROSENSOR. THEREFORE, THE PHYSICIAN RETRIEVED THE MICROSENSOR ON (B)(6), 2023 AND STOP MONITORING. THE PATIENT DID NOT EXPERIENCED ANY SIGN AND SYMPTOMS DUE TO SENSOR ISSUE. THE SENSOR WAS NOT REPLACED AND THE PATIENT IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17927386 ↗InjuryOct 12, 2023Leak/Splash; Leak/Splash
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS IMPLANTED ON (B)(6) 2023 AND 3 DAYS AFTER THE PROCEDURE, THE MICROSENSOR WAS LEAKING CEREBROSPINAL FLUID (CSF). THEN THE PHYSICIAN RETRIEVED THE PRODUCT AND STOP MONITORING. IT WAS EXPLANTED ON (B)(6) 2023. THE MONITOR USED WAS ICP EXPRESS, 220 VOLT (ID 826635) AND THE CABLE USED WAS ICP EXPRESS CABLE (ID 826636).
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 17926400 ↗InjurySep 1, 2023No Device Output; No Device Output
A FACILITY REPORTED A MICROSENSOR (826653) WAS IMPLANTED ON (B)(6) 2023. ON (B)(6) 2023 THE ICP MONITOR SHOWED NO READINGS, THEREFORE, THE MICROSENSOR WAS REPLACED. BASED ON THE INFORMATION PROVIDED, THE PATIENT DID NOT EXPERIENCED ANY SIGNS AND SYMPTOMS. THE SENSOR WAS USED WITH THE ICP MONITOR (826635) AND ICP CABLE (826636).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17673256 ↗
Other Device, monitoring, intracranial pressure devices
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- CereLink™ 826850Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 recall2 deaths112 reports
- Duet® 46913Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall58 reports
- Becker® 26040Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall46 reports
- 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.