Licox® IP2PRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10381780250333), received between Feb 3, 2022 and Oct 17, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Blocked Connection; Blocked Connection

  A FACILITY REPORTED THAT THE "KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER (IP2P)" WAS INSERTED ON THURSDAY, APRIL 10TH AND ON APRIL 12TH, PBO2 STARTED TO READ 500 AND CONTINUED TO DO SO. TEMPERATURE CONTINUES TO READ AT NORMAL PATIENT BASELINE VALUES, AND A CT SCAN WAS COMPLETED TO VERIFY PROBE PLACEMENT. A NEW MACHINE AND CABLE HAS BEEN SWITCHED OUT AND CONTINUED TO READ PBO2 AT 500. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: 1. WHAT TYPE OF PROCEDURE WAS PERFORMED? ANSWER: INSERTION OF LICOX, AFTER A FEW DAYS THE PBT02 BEGAN READING FALSELY HIGH NUMBERS. THE AVERAGE NUMBER WAS 500. 2. WAS THERE A DELAY IN SURGERY DUE TO PRODUCT PROBLEM? IF YES, HOW LONG WAS THE SURGICAL DELAY IN MINUTES? ANSWER: NO 3. HAS THE PROBE ALREADY REMOVED? IF YES, PLEASE PROVIDE DATE OF EXPLANTATION. ANSWER: NO 4. HOW WAS THE PATIENT MONITORED WHEN THE VALUES WERE INACCURATE? ANSWER: A CERELINK CATHETER WAS ALSO INSITU. WE CONTINUED TO MONITOR CLINICALLY AND IGNORED THE PBT02 VALUES 5. PLEASE CONFIRM IF THERE WAS ANOTHER PROBE INSERTED? ANSWER: YES A CERELINK CATHETER WAS INSITU 6. PATIENT OUTCOME/STATUS: ANSWER: REMAINS ADMITTED IN ICU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325103 ↗
• InjuryAug 10, 2024Incorrect Measurement; Incorrect Measurement

  N/A.

  Patient problems: Hematoma

  MAUDE report 19957456 ↗
• InjuryAug 10, 2024Incorrect Measurement; Incorrect Measurement

  THIS REPORT IS 3 OF 3 FOR THE 1ST LICOX PROBE IMPLANTED, AND IS LINKED TO MFG REPORT NUMBERS 3006697299-2024-00118 AND 3013886523-2024-00243: A FACILITY REPORTED THAT AFTER IMPLANTATION INVOLVING THE "KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER (IP2P)", THE VALUE REMAINED LOW AT 1-3 MMHG, NON-VARIABLE WITH A NEGATIVE FIO2 TEST. THE CT SCAN SHOWED A GOOD IMPLANTATION; HOWEVER, THE DAY AFTER ITS IMPLEMENTATION, THE TEMPERATURE SHOWED IMPROBABLE VALUES. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: DATE OF IMPLEMENTATION: (B)(6) 2024. DATE OF EXPLANTING: (B)(6) 2024. HAS ANOTHER CATHETER BEEN INSERTED? YES, THE (B)(6) 2024. HOW WAS THE PATIENT FOLLOWED UP WHEN THE VALUES WERE INACCURATE? EMPIRIC MANAGEMENT AND CONTROL BY CT SCANNER AND INFUSION. DECISION TO REPLACE ONE ON THIS BASIS ON 16 JULY. COMPLICATED PLACEMENT OF A SMALL EXTRA-SUBDURAL HEMATOMA. 2ND IMPLANTATION OF 16 JULY WITH HEMATOMA. 2ND PROBE WAS INDEED A LICOX. IT WORKED WELL BUT AFTER DELAY WITH LOW INITIAL VALUES AND LOW REACTIVITY AT FIO2 INCREASE. THE HEMATOMA WAS SECONDARY TO THE INSERTION OF THE PROBE. DID THE ISSUE(S) WITH THE PRODUCT ARISE BEFORE A SURGERY (PATIENT PREPARED/UNDER ANESTHESIA)? DURING SURGERY? WHEN FI

  Patient problems: Insufficient Information

  MAUDE report 19957455 ↗
• MalfunctionMar 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871685 ↗
• MalfunctionMar 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871671 ↗
• MalfunctionFeb 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  N/A.

  Patient problems: Hematoma

  MAUDE report 18764504 ↗
• InjuryFeb 3, 2022Difficult to Advance; Difficult to Advance

  A FACILITY REPORTED THAT THE COMPLETE BRAIN PROBE (P2PEU) DID NOT PASS THE PATIENT'S DURA MATER BUT "PUSH IT FORWARD." THE ISSUE LED TO AN AIR COLLECTION BETWEEN THE SKULL AND DURA (THE PROBE SEEMED TO HAVE PUSHED THE DURA FORWARD INSTEAD OF PASSING THROUGH IT). THERE WAS NO BLEEDING OR CONTUSIONS AND THE AIR COLLECTION HAD ALMOST FULLY RESOLVED (AS CHECKED ON CT SCAN OF THE BRAIN) ONCE THE BOLT/PROBE WAS REMOVED AND A NEW ONE PLACED ON THE CONTRALATERAL SIDE. A SINGLE LUMEN BOLT AND ICP PROBE FROM CAMINO WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO FURTHER PATIENT CONSEQUENCE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13443690 ↗