CODMAN MICROSENSOR 82-6653Recalls & reported problems
Cerenovus, Inc. · CODMAN MICROSENSOR Ventricular Catheter Kit With ICP Sensor Contains (1) Microsensor Ventricular Catheter, (1) Tunneling Trocar, (1) Catheter Anchoring Clip · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20886704042492), received between Jul 25, 2018 and Dec 28, 2022 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Leak/Splash1
- Unable to Obtain Readings1
Patient problems
- Cerebrospinal Fluid Leakage3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 28, 2022Leak/Splash; Leak/Splash
InjuryJan 26, 2022Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS IMPLANTED ON (B)(6) 2021 DURING AN EMERGENCY PROCEDURE. AFTER THE PROCEDURE, THE NURSE FOUND THAT THE MICROSENSOR WAS LEAKING A MINIMAL CEREBROSPINAL FLUID (CSF). THEREFORE, THE MICROSENSOR WAS RETRIEVED IN ADVANCE AND WAS NOT REPLACED.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 13358821 ↗InjurySep 3, 2021Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR WAS IMPLANTED INTO A PATIENT ON (B)(6) 2021 DURING AN EMERGENCY PROCEDURE. ON THE SAME DAY THE PATIENT WAS TRANSFERRED TO ICU, HOWEVER, THE NURSE OBSERVED CSF LEAKED ON A MICROSENSOR AT THE VOLUME OF 1 ML. THE PHYSICIAN WAS NOTIFIED AND REPLACED THE MICROSENSOR WITH ANOTHER 826653.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 12421362 ↗MalfunctionJul 25, 2018Unable to Obtain Readings; Unable to Obtain Readings
AS REPORTED BY THE AFFILIATE, DURING PRE-USE TESTING PRIOR TO USE ON THE PATIENT, A MICROSENSOR REGISTERED NO DATA AFTER BEING CONNECTED TO AN ICP MONITOR. MONITORING WAS DISCONTINUED. THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7719856 ↗
Other DEVICE, MONITORING, INTRACRANIAL PRESSURE devices
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- 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
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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