Cardiovascular Procedure Kit CX-UK695Recalls & reported problems
Terumo Cardiovascular Systems Corporation · Class 2
All models of Cardiovascular Procedure Kit (227)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00699753531154), received between Oct 15, 2025 and Sep 23, 2026 — classified as 2 malfunctions.
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
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872965 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE INFANT PACK HAD A LEAKING CONNECTOR. AS MITIGATION, THE TEAM REPLACED THE CONNECTOR AND MADE SURE THE LINE WAS SECURE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A REPORTED DELAY OF 20 MINUTES. THERE WAS MINIMAL BLOOD LOSS OF AN UNKNOWN AMOUNT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23303072 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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