Cardiovascular Procedure Kit CX-FR248Recalls & reported problems
Terumo Cardiovascular Systems Corporation
All models of Cardiovascular Procedure Kit (227)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699753518414), received between Jan 8, 2025 and Jan 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
PER CLINICAL REVIEW: THIS COMPLAINT FROM THE USER FACILITY INVOLVED AN OXYGENATOR AND TUBING PACK THAT HAD A BLOOD LEAK DEVELOP AT THE ARTERIAL OUTLET PORT AND TUBING CONNECTION THAT WAS FACTORY TIE-BANDED. THIS OCCURRED DURING CARDIOPULMONARY BYPASS. THERE WAS A LOSS OF BLOOD FROM A SLOW DRIP, BUT THE VOLUME OF BLOOD LOSS WAS NOT OBJECTIVELY MEASURABLE PER THE REPORTED INFORMATION. THE OXYGENATOR WAS NOT CHANGED OUT. THERE WAS NO DELAY AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE OXYGENATOR WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. A PICTURE WAS SHARED BY THE USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21106692 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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