Codman Microsensor® 826631Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN MICROSENSOR® Basic Kit for Subdural/Intraparenchymal procedure · Class 2
Quick summary
This Codman Microsensor is a small implantable probe used to track pressure inside the skull during surgery. Most of the 76 reports describe the sensor giving wrong or unstable pressure readings, sometimes showing impossible values, so monitors were stopped and the sensor removed; others mention the device failing to produce any signal, breaking, or failing to zero. There are 49 injuries and no deaths, and 27 reports are filed as malfunctions. 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
- 75
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10381780520412), received between Dec 16, 2021 and Jul 16, 2026 — classified as 47 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (31 reports).
3 other recalls cover devices cleared under the same FDA submission (K914479); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings31
- Failure to Read Input Signal12
- No Device Output7
- Break6
- Failure to Zero6
- Connection Problem3
- Output Problem3
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- Insufficient Information23
- Failure of Implant2
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2026Fracture
A FACILITY REPORTED A SENSOR TIP (ID 826631) BROKE DURING PROCEDURE. THE SURGEON SUCCESSFULLY REMOVED ALL BROKEN FRAGMENTS DURING THE PROCEDURE, AND NO PATIENT HARM WAS CAUSED. THE EVENT LED TO 10 MINUTES SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25846092 ↗InjuryJun 12, 2026Improper Flow or Infusion
A FACILITY REPORTED A MICROSENSOR (ID 826631) WAS IMPLANTED ON (B)(6), 2026. POSTOPERATIVELY, THE PATIENT RETURNED TO THE WARD WITH UNSTABLE INTRACRANIAL PRESSURE (ICP) READINGS, WHICH FLUCTUATED ABNORMALLY FROM 30 MMHG TO OVER 300 MMHG. THEREFORE, THE PHYSICIAN STOPPED THE MONITORING AND THE MICROSENSOR WAS CONSEQUENTLY REMOVED ON (B)(6), 2026. THE PATIENT IS STABLE. THE SENSOR WAS USED WITH MONITOR: ICP EXPRESS, 220 VOLT (ID 826635) AND CABLE: ICP EXPRESS CABLE (ID 826636).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25485470 ↗MalfunctionMay 15, 2026Contamination
A FACILITY REPORTED THAT AFTER UNPACKING THE MICROSENSOR (ID (B)(6)), THE PHYSICIAN FOUND THAT THERE WAS A FOREIGN MATTER (HAIR) INSIDE THE SENSOR PACKAGING. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25183280 ↗InjuryFeb 13, 2026Break; No Device Output
InjuryJan 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED A MICROSENSOR (ID (B)(6)) WAS IMPLANTED ON (B)(6) 2026. THE SENSOR SHOWED INACCURATE INTRACRANIAL PRESSURE (ICP) READINGS. THEREFORE, THE SENSOR WAS RETRIEVED ON THE SAME DATE, (B)(6) 2026, AND MONITORING WAS STOPPED. THE MONITOR AND CABLE USED WERE ICP EXPRESS, 220 VOLT MONITOR (ID (B)(6)) AND ICP EXPRESS CABLE (ID (B)(6)).
Patient problems: Insufficient Information
MAUDE report 24198614 ↗InjuryJan 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
InjuryJan 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED A MICROSENSOR (ID: 826631) WAS IMPLANTED ON (B)(6) 2026. THE ICP EXPRESS, 220 VOLT (ID: 826635) SHOWED 165 MMHG. HOWEVER, ALL POST-EXAMINATION INDICATORS OF THE PATIENT WERE NORMAL. THEN THE PHYSICIAN CONNECTED THE MICROSENSOR TO ANOTHER ICP MONITOR; IT STILL SHOWED 168 MMHG, WHICH WAS INCONSISTENT WITH THE PATIENT¿S STATUS. THEREFORE, THE SENSOR WAS REMOVED ON (B)(6) 2026, AND MONITORING WAS STOPPED. THE CABLE USED WAS ICP EXPRESS CABLE (ID: 826636).
Patient problems: Insufficient Information
MAUDE report 24198279 ↗InjuryDec 18, 2025Break; Break
InjuryOct 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
InjuryAug 28, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
InjuryAug 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED A MICROSENSOR (ID 826631) WAS PLACED ON (B)(6) 2025 AND DISPLAYED NORMAL READINGS DURING SURGERY. AFTER THE PATIENT WAS TRANSFERRED BACK TO THE WARD, THE SENSOR BEGAN SHOWING ABNORMAL VALUES. THE MEDICAL STAFF ATTEMPTED SEVERAL TROUBLESHOOTING MEASURES, INCLUDING RESTARTING THE MONITORING DEVICE, REPLACING THE ICP MONITOR, AND CHANGING THE CONNECTING CABLES; HOWEVER, THE ABNORMAL READINGS PERSISTED. THEREFORE, THE PHYSICIAN RETRIEVED THE DEVICE AND DISCONTINUED MONITORING DUE TO SUSPECTED SENSOR FAILURE. THERE IS NO INFORMATION AVAILABLE REGARDING WHETHER THE PATIENT EXPERIENCED ANY SIGNS OR SYMPTOMS RELATED TO THE SENSOR ISSUE. THE PATIENT IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22809205 ↗InjuryJun 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
InjuryJun 18, 2025No Device Output; No Device Output
A FACILITY REPORTED THAT ON (B)(6) 2025, THE NURSING TEAM INITIATED INTRACRANIAL PRESSURE (ICP) MONITORING FOR A PATIENT DIAGNOSED WITH ACUTE SEVERE TRAUMATIC BRAIN INJURY, UTILIZING AN ICP SENSOR (ID 826631) INTEGRATED WITH AN ICP MONITORING DEVICE. ON (B)(6) THE NURSE OBSERVED A LOSS OF DATA TRANSMISSION FROM THE ICP MONITOR. THE MONITORING DEVICE WAS PROMPTLY REPLACED; HOWEVER, THE ISSUE PERSISTED. THE ROOT CAUSE SUSPECTED: A COVERT FRACTURE OF THE ICP SENSOR LEAD WIRE (CONFIRMED DURING POST-EVENT ANALYSIS). AFTER REPLACING THE ICP SENSOR WITH A NEW UNIT, STABLE ICP MONITORING WAS SUCCESSFULLY RESTORED. THE MONITOR AND CABLE USED WERE ICP EXPRESS - MONITOR (ID 826635) AND ICP EXPRESS - CABLES (ID 826636).
Patient problems: Insufficient Information
MAUDE report 22283737 ↗InjuryJun 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED A MICROSENSOR (ID 826631) WAS IMPLANTED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) EXAMINATION, THE ICP SENSOR FAILED TO RECONNECT SUCCESSFULLY, DISPLAYING AN ERROR CODE OF "-99." TROUBLESHOOTING WAS ATTEMPTED, AND BOTH THE ICP MONITOR UNIT AND CABLE ASSEMBLY WERE REPLACED; HOWEVER, THIS DID NOT RESOLVE THE PAIRING ISSUE. DUE TO THE FAILURE, THE SENSOR WAS REMOVED. THE PATIENT DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS AS A RESULT OF THE SENSOR FAILURE. THE SENSOR WAS NOT REPLACED, AND THE PATIENT'S CONDITION IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283717 ↗InjuryJun 13, 2025No Device Output; Incorrect, Inadequate or Imprecise Result or Readings; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings
InjuryMay 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A PHYSICIAN REPORTED A MICROSENSOR (ID: 826631) VALUE COULD NOT BE MEASURED CORRECTLY AFTER THE PATIENT VOMITED AND THE VOMIT GOT INSIDE THE SENSOR. THEREFORE, THE SENSOR WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061509 ↗InjuryMay 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED THAT AFTER THE MICROSENSOR WAS IMPLANTED, THE ICP READING WAS ALWAYS NEGATIVE. THREE DAYS LATER, THE ICP READINGS WERE STILL INCORRECT AND NEGATIVE, THEREFORE THE PHYSICIAN RETRIEVED THE MICROSENSOR AND STOP MONITORING.
Patient problems: Insufficient Information
MAUDE report 22054616 ↗MalfunctionJan 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED A MICROSENSOR (ID 826631) SHOWED -99 MMHG IN THE ICP MONITOR (ID 826635). THE EVENT HAPPENED BEFORE IMPLANTATION SITE CLOSURE AND NO SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21137716 ↗MalfunctionJan 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED A MICROSENSOR (ID (B)(6)) COULD BE ZEROED NORMALLY DURING PRE- TESTING BEFORE IMPLANTATION. A WHILE AFTER THE MICROSENSOR WAS IMPLANTED, THERE WAS NO ICP READINGS ON THE ICP MONITOR. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY REPORTED, AND THE EVENT DID NOT LED TO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21071810 ↗InjuryOct 31, 2024Failure to Transmit Record; Failure to Transmit Record
InjuryOct 24, 2024No Device Output; Failure to Zero; No Device Output; Failure to Zero
A FACILITY REPORTED A SENSOR (ID 826631) COULD NOT BE RECOGNIZED AND THE ZERO POINT ADJUSTING DISPLAY DID NOT SHOW UP. THE ICP EXPRESS AND THE CORD WERE REPLACED BUT IT COULD NOT BE RECOGNIZED STILL. THE DEVICE WAS NOT IMPLANTED, AND THE SITE WAS CLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20524951 ↗MalfunctionOct 17, 2024Break; Break
A FACILITY REPORTED THAT ON (B)(6) 2024, AN ICP MICROSENSOR (ID 826631) WAS IMPLANTED. WHEN THE PHYSICIAN WAS ABOUT TO CLOSE THE IMPLANTATION SITE, THE MICROSENSOR BROKE INTO SEVERAL PIECES AFTER THE PHYSICIAN GENTLY PULLED THE MICROSENSOR. THEREFORE, THE SENSOR WAS RETRIEVED AND THE PATIENT'S ICO COULD NOT BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20473494 ↗InjurySep 13, 2024No Device Output; No Device Output
A FACILITY REPORTED A MICROSENSOR (ID 826631) WAS PLACED ON (B)(6) 2024. AFTER 4 DAYS, THE MICROSENSOR COULD NOT SHOW THE INTRACRANIAL PRESSURE (ICP) READINGS. THE PHYSICIAN CHANGED THE ICP MONITOR TO CONNECT TO THE MICROSENSOR, BUT IT STILL COULD NOT DISPLAY THE ICP READINGS. THEREFORE, THEY RETRIEVED THE DEVICE AND STOPPED MONITORING. THE MONITOR AND CABLE USED WERE ICP EXPRESS, 220 VOLT (ID 826635) AND ICP EXPRESS CABLE (ID 826636).
Patient problems: Insufficient Information
MAUDE report 20212678 ↗InjurySep 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
InjuryJul 12, 2024Failure to Read Input Signal; Failure to Read Input Signal
A PHYSICIAN REPORTED A MICROSENSOR (ID 826631) WAS PROPERLY DISPLAYING VALUE UNTIL NOON OF THE DAY AFTER IMPLANTATION. WHEN THE DEVICE WAS RECONNECTED AFTER TRANSFERRING THE PATIENT FOR DIAGNOSTIC IMAGING, THE VALUE WAS NOT DISPLAYED AT ALL. THEREFORE, THE SENSOR WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. ACCORDING TO INFORMATION PROVIDED, THE CABLE AND THE MONITOR USED ALONG WITH THE SENSOR ARE UNKNOWN. IT IS ALSO UNKNOWN IF THE PATIENT EXPERIENCED SIGNS AND SYMPTOMS DUE TO DEVICE ISSUE.
Patient problems: Insufficient Information
MAUDE report 19731515 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K914479. One submission often covers many models, so check the product and lot details in each record.
- Z-1614-2023 · Apr 11, 2023 · Open, ClassifiedCodman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Par
- Z-0706-2012 · Oct 25, 2011 · TerminatedCodman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xy
- Z-0707-2012 · Oct 25, 2011 · TerminatedCodman Cranial Access Kit - complete with Xylocaine Product Code: 82-6614 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and th
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
- 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® 826653Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure68 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.