CODMAN® IPC EXPRESS® 826634Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® IPC EXPRESS® Power Supply 120/127 VAC 50-60HZ · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780520443), received between Sep 21, 2022 and Dec 11, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Read Input Signal” (1 report).
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
- Failure to Read Input Signal1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2025Overheating of Device; Overheating of Device
A FACILITY REPORTED AN INTRACRANIAL PRESSURE (ICP) MONITOR (ID 826634) WAS NOT READING CORRECTLY AND IT WAS OVERHEATING. NO PATIENT CONTACT/INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23782485 ↗InjurySep 21, 2022Failure to Read Input Signal; Failure to Read Input Signal
THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3014334038-2022-00209, 3013886523-2022-00433. A FACILITY REPORTED A MICROSENSOR (ID 826851) WAS IMPLANTED ON (B)(6) 2022. IN THE MORNING OF (B)(6) 2022 THE PATIENT WAS DISCONNECTED FROM ICP EXPRESS MONITOR (ID 826634) AND TRANSPORTED TO A "CT". UPON ARRIVAL BACK TO THE PEDIATRIC "ICU" FROM "CT" THE MICROSENSOR WAS RECONNECTED TO THE ICP EXPRESS AND MESSAGE ¿SENSOR NOT DETECTED¿ APPEARED. TROUBLESHOOTING WAS COMPLETED (CHANGED MONITORS) AND THE SAME MESSAGE APPEARED. THEREFORE, THE MICROSENSOR WAS REMOVED AND REPLACED ON (B)(6) 2022 AND THE APPROPRIATE INTRACRANIAL PRESSURE VALUE WAS RECEIVED. THE TWO MONITORS ARE STILL WORKING FINE AFTER A NEW MICROSENSOR WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15462092 ↗
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
- 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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