DIRECTLINK 82-6828Recalls & reported problems
Medos International Sàrl · DirectLink ICP Module · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886704078661), received between Jul 23, 2018 and Oct 24, 2025 — classified as 8 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings8
- Imprecise or Erratic Results2
- Low Readings1
- No Device Output1
- Non Reproducible Results1
- Overheating of Device1
- Power Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2025Power Problem; Power Problem
IT WAS REPORTED THAT THE ELECTROSURGICAL GENERATOR POOL UNIT (901001ESUO) HAD "BIPOLAR CHANNEL 2 FUNCTIONING ANOMALIES". THE ISSUE WAS REPORTEDLY DISCOVERED "AT THE BEGINNING OF THE SURGERY", RESULTING IN A DELAY OF AT LEAST 30 MINUTES. IT IS UNCLEAR WHETHER THE DELAY OCCURRED PRIOR TO THE SURGERY OR DURING ACTIVE SURGERY. NO PATIENT ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378472 ↗MalfunctionSep 24, 2024Overheating of Device; Overheating of Device
MalfunctionAug 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
InjuryAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
1 OF 12 REPORTS (DIFFERENT PATIENTS, SAME FAILURE). OTHER MFG REPORT NUMBERS: 3013886523-2024-00229, 3013886523-2024-00230, 3013886523-2024-00231, 3013886523-2024-00232, 3013886523-2024-00233, 3013886523-2024-00234, 3013886523-2024-00235, 3013886523-2024-00236, 3013886523-2024-00237, 3013886523-2024-00238, 3013886523-2024-00239. CASE 1: A FACILITY REPORTED A DIRECTLINK MODULE (ID 826828) WITH INCONSISTENT VALUES. THE MODULE WAS USED WITH CERELINK SENSOR (ID 826851). THE SENSOR WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950134 ↗InjuryAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
InjuryAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
InjuryAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
3 OF 12 REPORTS (DIFFERENT PATIENTS, SAME FAILURE). OTHER MFG REPORT NUMBERS: 3013886523-2024-00228, 3013886523-2024-00229, 3013886523-2024-00231, 3013886523-2024-00232, 3013886523-2024-00233, 3013886523-2024-00234, 3013886523-2024-00235, 3013886523-2024-00236, 3013886523-2024-00237, 3013886523-2024-00238, 3013886523-2024-00239. CASE 2: A FACILITY REPORTED A DIRECTLINK MODULE (ID 826828) WITH INCONSISTENT VALUES. THE MODULE WAS USED WITH CERELINK SENSOR (ID 826851). THE SENSOR WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950103 ↗InjuryAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
9 OF 12 REPORTS (DIFFERENT PATIENTS, SAME FAILURE). OTHER MFG REPORT NUMBERS: 3013886523-2024-00228, 3013886523-2024-00229, 3013886523-2024-00230, 3013886523-2024-00231, 3013886523-2024-00232, 3013886523-2024-00233, 3013886523-2024-00234, 3013886523-2024-00235, 3013886523-2024-00237, 3013886523-2024-00238, 3013886523-2024-00239. CASE 5: A FACILITY REPORTED A DIRECTLINK MODULE (ID 826828) WITH INCONSISTENT VALUES. THE MODULE WAS USED WITH CERELINK SENSOR (ID 826851). THE SENSOR WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950096 ↗InjuryAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
MalfunctionMar 5, 2024Imprecise or Erratic Results; Imprecise or Erratic Results
1 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2024-00065 3013886523-2024-00066. A FACILITY REPORTED A PATIENT WAS HOSPITALIZED DUE TO TRAUMATIC BRAIN INJURY FOR APPROXIMATELY ONE TO AN HALF WEEKS, DECOMPRESSED BILATERALLY. INTRACRANIAL PRESSURE MEASUREMENTS WITH INTRAPARENCHYMAL SENSOR AND DIRECT LINK WERE UNRELIABLE VALUES (TOO HIGH/TOO LOW). THEREFORE, THE SYSTEM WAS REPLACED WITH INTRAVENTRICULAR SENSOR BUT THE PROBLEM REMAINED. THE FIRST SENSOR WAS IMPLANTED ON (B)(6) 2024; EXPLANTED ON (B)(6) 2024. SECOND SENSOR IMPLANTED ON (B)(6) 2024; EXPLANTED (B)(6) 2024. MEDICAL STAFF CONTINUED WITH NOT INVASIVE MONITORING (TCD DIASTOLIC FLOW VELOCITY AND OPTIC NERVE SHEAT).
Patient problems: Insufficient Information
MAUDE report 18838246 ↗InjuryFeb 13, 2024No Device Output; No Device Output
2 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2024-00039 3013886523-2024-00041. A FACILITY REPORTED A CERELINK SENSOR (B)(6) HAD VERY HIGH PRESSURE (300), AND THEN A FLAT LINE WAS SEEN FIVE HOURS AFTER PLACEMENT. THE SENSOR WAS REMOVED AND REPLACED. THE SECOND SENSOR WORKED FOR 11 HOURS, THEN SUDDENLY, FLAT LINE. IT WAS EXPLANTED AND MONITORING STOPPED. THE SENSORS WERE CONNECTED TO DIRECTLINK MODULE (ID 826828).
Patient problems: Insufficient Information
MAUDE report 18697903 ↗InjuryOct 18, 2023Imprecise or Erratic Results; Imprecise or Erratic Results
MalfunctionApr 6, 2022Low Readings; Low Readings
1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2022-00136. 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 14021214 ↗MalfunctionApr 8, 2021Non Reproducible Results; Non Reproducible Results
A FACILITY REPORTED AN ICP MICROSENSOR DISPLAYED INCORRECT READINGS. THE MICROSENSOR WAS IMPLANTED AND CONNECTED TO A DIRECT LINK MONITOR ON AN UNKNOWN DATE. REPORTEDLY A NUMERICAL INTRACRANIAL PRESSURE WAS NOT DISPLAYED ON THE BEDSIDE MONITOR, BUT THE MONITOR DID DISPLAY A WAVEFORM. THE FACILITY PERFORMED TROUBLE SHOOTING MEASURES AND THE PATIENT CABLE AND MONITOR CABLE WERE CHANGED AND THE RE-SYNCHRONIZED TO THE DIRECTLINK AND TO THE BEDSIDE MONITOR. WHEN THE -0- FROM THE DIRECT LINK (WHEN THE GREEN LIGHT WAS LIT) AND THE NURSE ZEROED OUT THE BESIDE MONITOR, THE BEDSIDE MONITOR DISPLAYED A VALUE OF 20MMHG. THE FACILITY THEN CHECKED THE 100 SCALE AND ONCE THE NURSE PRESSED THE ARROW SO THE GREENLIGHT WAS ON THE 100, THE BEDSIDE DISPLAYED 120MMHG, THEN AN ERROR MESSAGE APPEARED. THE ERROR MESSAGE DISPLAYED ¿SENSOR P2 FAIL¿ AND THE WAVEFORM AND THE NUMERICAL VALUE WENT AWAY. THE FACILITIES BIO MEDICAL ENGINEER WHO IS ALSO THE GE ENGINEER CAME TO THE BEDSIDE TO HELP TROUBLESHOOT. THE BIOMEDICAL ENGINEER DISCONNECTED THE PATIENT CABLE FROM THE DIRECT LINK BOX AND PROCEEDED TO CHECK BOTH CONNECTING CABLES WITH THE DIRECT LINK BOX. BOTH DIRECT LINK CONNECTING CABLES WERE CHECKED SEPARAT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11635168 ↗MalfunctionJul 23, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
AS REPORTED BY THE REP, AFTER A DIRECTLINK GAVE INCORRECT READINGS FOLLOWING POST -OP INSERTION OF THE MICROSENSOR, THEN EN-ROUTE TO THE ICU, THE ICP READ "???". AFTER UNSUCCESSFULLY ATTEMPTING TO RE-SYNCHRONIZED THE DIRECT LINK, THE CABLE WAS CHANGED THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7710054 ↗
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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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