DirectLink™ 826840Recalls & reported problems
Integra LifeSciences Switzerland Sàrl · DirectLink® ICP Extension Cable · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780520610), received between May 24, 2022 and May 24, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
3 OF 3 REPORTS. OTHER MFG REPORT NUMBERS; 3013886523-2022-00211, 3013886523-2022-00212. A FACILITY REPORTED THE PROCEDURE OF THE INSERTION OF THE PIC WENT WITHOUT COMPLICATIONS. DEVICE WORK ASK EXPECTED FOR 3 HOURS, THEN THE INTRACRANIAL PRESSURE WENT FROM 6 MMHG TO THE BOTTOM OF THE SCALE. NO PATIENT MOVEMENT OR DEVICE MANIPULATION OCCURRED. THE INSERTION OF THE NEW DEVICE WAS PERFORMED CHANGING ALSO THE MONITOR CABLE, THE JUNCTION BOX AND THE CONNECTION CABLE-DEVICE. THE DEVICE WAS USED IN A 47 YEAR-OLD FEMALE PATIENT FOR MONITORING AND CONTROLLING INTRACRANIAL PRESSURE IN A PATIENT WITH SEVERE HEAD INJURY/TRAUMA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14489412 ↗
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
- 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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