DirectLink™ 826828Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10381780515784), received between Apr 6, 2022 and Oct 10, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2025Incorrect Measurement; Incorrect Measurement

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23266825 ↗
• MalfunctionJan 28, 2025Connection Problem; Connection Problem

  2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2025-00018. A FACILITY REPORTED A MICROSENSOR BASIC KIT (ID: 626631) WAS PLACED IN THE OPERATIVE ROOM, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE ICU STAFF WAS NEVER ABLE TO RETRIEVE DATA. THE DIRECT LINK MONITOR (UNKNOWN ID) AND SENSOR NEVER DISPLAYED A GREEN ACTIVE LIGHT AND THE CONNECTION TO THE PATIENT MONITOR WAS NOT SHOWING UP EITHER. NO ACTIVITY FROM THE SENSOR VIA THE DIRECTLINK AND PATIENT MONITOR, THEREFORE, THE SENSOR WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21254401 ↗
• MalfunctionJan 31, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619284 ↗
• InjuryNov 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  1 OF 5 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2023-00424, 3013886523-2023-00426, 3013886523-2023-00428, 3013886523-2023-00427. A FACILITY REPORTED: THE WHOLE PROCEDURE FROM CALIBRATION DIRECKTLINK TO THE MONITOR, THE ZEROING FROM THE SENSOR AND IMPLEMENTATION WENT WELL. NO ORANGE OR RED LIGHT ON THE DIRECTLINK. BUT AFTER PLACING THE FIRST SENSOR AFTER 6 HOURS ICP FLUCTUATION (HERE WAS THE SCREW LUXATED) AND THEN PLACED 3 SENSORS AGAIN, ALSO WITH FLUCTUATIONS IN VERY HIGH ICP, LOW ICP AND ALSO A FLAT LINE. IT WAS A VERY COMPLEX TRAUMA PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18222031 ↗
• MalfunctionAug 15, 2023Output Problem; Output Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549611 ↗
• MalfunctionJan 13, 2023Incorrect Measurement; Incorrect Measurement

  OTHER MFG REPORT NUMBER: 3013886523-2022-00599. A FACILITY REPORTED NEGATIVE VALUES OF A CERELINK MICROSENSOR (ID 826851). THE SENSOR WAS USED WITH DIRECTLINK ICP MODULE (ID 826828). MONITORING WAS NOT POSSIBLE, THEREFORE, SENSOR WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158899 ↗
• InjuryJan 4, 2023Low Readings; Low Readings

  2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2022-00591. A FACILITY REPORTED A CERELINK SENSOR WAS IMPLANTED, THE VALUES WERE STABLE FOR ONE DAY UNTIL SUDDENLY DROPPED TO NEGATIVE NUMBERS. THE SENSOR AND THE DIRECTLINK MONITOR WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096243 ↗
• MalfunctionNov 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 15753542 ↗
• MalfunctionNov 8, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  N/A

  Patient problems: Insufficient Information

  MAUDE report 15753428 ↗
• InjuryMay 24, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  2 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2022-00211 AND 3013886523-2022-00214. 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 14489389 ↗
• MalfunctionApr 6, 2022Low Readings; Low Readings

  2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2022-00135. A FACILITY REPORTED A DIRECTLINK ICP MODULE WAS SHOWING NEGATIVE READINGS AFTER IMPLANTATION. THE SENSOR WAS REPLACED AND ONE HOUR SURGICAL DELAY WAS REPORTED BECAUSE WHEN THE SENSOR WAS REPLACED, THE NEGATIVE READINGS PERSISTED; THEREFORE, THE SENSORS WERE NOT THE CAUSE. THE MONITORING CONTINUED WITH A COMPETITOR MODULE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021219 ↗