CAPIOX CX*FX05REARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04987350739063), received between Nov 11, 2024 and Jan 8, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Gas/Air Leak

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THERE WAS EXCESS WATER FROM THE GAS LINE CONNECTION TO TRAP. THE EVENT OCCURRED DURING PRIME. THE EVENT DID NOT RESULT IN THE DELAY OF THE SURGICAL PROCEDURE. THE PRODUCT WAS CHANGED OUT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID NOT CAUSE OR CONTRIBUTE TO AN INJURY. NO BLOOD LOSS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004169 ↗
• MalfunctionJan 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE USER FACILITY REPORTED THAT THE CASES WERE DAMAGED BY A WET, MOLD-LIKE SUBSTANCE. THIS SUBSTANCE WAS FOUND ON THE CASES AND CAUSED THE DAMAGE. THE OUTER BOX REMAINED UNAFFECTED, INDICATING THE ISSUE ORIGINATED FROM INSIDE THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21075615 ↗
• MalfunctionJan 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE USER FACILITY REPORTED THAT THE CASES WERE DAMAGED BY A WET, MOLD-LIKE SUBSTANCE. THIS SUBSTANCE WAS FOUND ON THE CASES AND CAUSED THE DAMAGE. THE OUTER BOX REMAINED UNAFFECTED, INDICATING THE ISSUE ORIGINATED FROM INSIDE THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21075614 ↗
• MalfunctionJan 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE USER FACILITY REPORTED THAT THE CASES WERE DAMAGED BY A WET, MOLD-LIKE SUBSTANCE. THIS SUBSTANCE WAS FOUND ON THE CASES AND CAUSED THE DAMAGE. THE OUTER BOX REMAINED UNAFFECTED, INDICATING THE ISSUE ORIGINATED FROM INSIDE THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21075612 ↗
• MalfunctionNov 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE USER FACILITY REPORTED THAT THE CASES WERE FOUND DAMAGED DUE TO A WET MOLD SUBSTANCE UPON OPENING THE BOXES. THERE IS NO SURGERY-RELATED INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20660556 ↗