CODMAN ICP EXPRESS 82-6634Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886704042341), received between Aug 3, 2018 and Dec 11, 2023 — classified as 2 injuries, 7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2023Failure to Read Input Signal; Failure to Read Input Signal

  N/A

  Patient problems: Insufficient Information

  MAUDE report 18300085 ↗
• InjurySep 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2023-00330. A FACILITY REPORTED A CERELINK SENSOR (ID (B)(6)) WAS IMPLANTED ON (B)(6), 2023. THE ICP MEAN DECREASED AND STARTED READING NEGATIVE APPROXIMATELY 2 HOURS 20 MINUTES POST INSERTION. IN THE OPERATING ROOM PER THE OUTPATIENT NOTE, WHEN THE SENSOR WAS PLACED, THE OPENING PRESSURE WAS 19 AT APPROXIMATELY 1330, AFTER THE VENTRICULAR CATHETER WAS REPLACED, THE ICP DROPPED TO 11. THE PATIENT & MONITOR WERE TRANSPORTED TO THE POST ANESTHESIA CARE UNIT (JUST DOWN THE HALL) DURING TRANSPORTATION, THE ICP MONITOR DIED. PRIOR TO THIS THE ICP MONITOR HAD BEEN PLUGGED IN. AFTER BEING PLUGGED IN (IN PACU) THE ICP MONITOR SHOWED AN ICP OF 3 AT APPROXIMATELY 1410. THE ICP MONITOR WAS REQUESTING "ZERO TO PATIENT MONITOR". THE MONITORS IN THE PACU DO NOT HAVE THE CAPABILITY TO MONITOR ICPS. AT THAT POINT, THE PATIENT WAS TAKEN TO THE PEDIATRIC INTENSIVE CARE UNIT WHERE THE ICP MONITOR READ 2-3 AT -1448. THERE HAD BEEN AN UNSUCCESSFUL ATTEMPT TO "ZERO" TO THE PATIENT MONITOR. THE INTERFACE CABLE WAS DISCONNECTED FROM THE PATIENT MONITOR, THEN RECONNECTED, ACCEPTED THE REFERENCE #500 AS IT WAS CORRECT, ZEROED TO THE PATIENT MONITOR, PRESSE

  Patient problems: Insufficient Information

  MAUDE report 17781289 ↗
• MalfunctionSep 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED: "THE SPECIALIST RECEIVED A CALL FROM NEUROSURGEON. HE STATED HE HAS BEEN CARING FOR A 35 Y/O S/P SEVERE TBI PATIENT AND DOESN¿T FEEL THE ICP VALUES OBTAINED FROM THE ICP EXPRESS ARE ACCURATE. THE PATIENT WAS ADMITTED ON (B)(6). AND AN ICP SENSOR WAS PLACED (ICP EXPRESS + CERELINK MICROSENSOR SKULL BOLT KIT). UPON ADMISSION AND AFTER IMPLANTATION OF THE ICP SENSOR, THE ICP VALUE MEASURED 4MMHG, HE DIDN¿T FEEL THE VALUE WAS REFLECTIVE OF THE PATIENT¿S CONDITION FOR SHE WAS UNRESPONSIVE, VENTILATOR DEPENDENT, AND HER CT SHOWED MULTIPLE CONTUSIONS, MASSIVE CEREBRAL EDEMA WITH SLIT VENTRICULAR SYNDROME. HE CHANGED THE ICP SENSOR BUT THAT DIDN¿T AFFECT THE VALUE. HE ENDED UP DOING SERIAL CT SCANS IN ORDER TO MONITOR THE PATIENT. HE AND THE CHARGE NURSE WERE UNAWARE OF A 2ND ICP EXPRESS AVAILABLE TO THEM, SO THEY DID NOT CHANGE OUT THE MONITOR. THE FOLLOWING DAY, THE NEUROSURGEON CALLED STATING THAT NOW THE ICP VALUES WERE LABILE AND INACCURATE FOR EVEN WITHOUT STIMULUS AND OVER EVERY COUPLE OF SECONDS THE ICP GO FROM 14MMHG TO 40MMHG, THEN DOWN TO 4MMHG. THEY WERE ABLE TO LOCATE A 2ND ICP EXPRESS AND SWITCH IT OUT. AFTER CHANGING MONITORS, THE ICP VALUE (PER NEUROSURGEON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17738084 ↗
• MalfunctionAug 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 17436069 ↗
• MalfunctionOct 11, 2022Output Problem; Output Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583221 ↗
• MalfunctionSep 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: (B)(4). A FACILITY REPORTED A CERELINK MICROSENSOR (ID 826851) WAS PLACED ON (B)(6) 2022. THE INITIAL READING WAS 3. THE ICP EXPRESS MONITOR WAS WORKING CORRECTLY AND INTRACRANIAL PRESSURE (ICP) WAS BEING DISPLAYED. WHEN THE ICP EXPRESS WAS PLUGGED IN TO THE BEDSIDE MONITOR, THE BEDSIDE WAS ZEROED CORRECTLY AND WAS MATCHING THE CORRECT ICP. IN THE MORNING OF (B)(6) 2022, THE ICP EXPRESS BEGAN READING A NEGATIVE ICP. THE WAVEFORM LOOKED GREAT, BUT NO TROUBLESHOOTING WAS ABLE TO FIX THE NEGATIVE READING. THEREFORE, THE SURGEON DECIDED TO PLANT AND REPLACE THE SENSOR ON (B)(6) 2022. A NEW CERELINK MICROSENSOR WAS IMPLANTED AND IS READING NORMAL ICP. THE ICP EXPRESS MONITOR WAS WORKING CORRECTLY CLINICAL QUESTIONNAIRE PROVIDED: HOSPITAL NAME: (B)(6), HOSPITAL LOCATION: (B)(6). TIME/DATE OF FAILURE: 5 AM (B)(6) 2022, DESCRIPTION OF THE FAILURE: READING NEGATIVE ICP. SENSOR INFORMATION A. KIT USED: METAL BOLT (826851), B. SERIAL NUMBER: (B)(4). D. IMPLANT LOCATION: PARENCHYMAL. E. HOSPITAL LOCATION OF IMPLANT: ICU CERELINK MONITOR SERIAL NUMBER: (B)(4), DID THE FAILURE OCCUR DURING PATIENT MOVEMENT? (I.E. REPOSITION, TRANSPORT, OUT OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15512155 ↗
• InjurySep 21, 2022Failure to Read Input Signal; Failure to Read Input Signal

  THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3014334038-2022-00208, 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 15462110 ↗
• MalfunctionJul 17, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE ICP EXPRESS MONITOR IS HAVING NEGATIVE NUMBERS WHEN CONNECTING TO THE PROBE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10292978 ↗
• MalfunctionAug 3, 2018Low Readings; Low Readings

  AS REPORTED BY THE AFFILIATE, AN ICP EXPRESS WOULD NOT REACH THE PROPER READING AFTER BEING ZEROED. AFTER BEING ZEROED, THE MONITOR WOULD NOT CLIMB TO 20. THE HIGHEST THE MONITOR WOULD REACH IS 6, AND WOULD CLIMB VERY SLOWLY. ANOTHER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7746696 ↗