Cardiovascular Procedure Kit 77593Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00699753514874), received between Jan 11, 2024 and Mar 7, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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. 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
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2024Break; Break
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE TUBING BROKE AT THE MANIFOLD. AS A MITIGATION, IT WAS CLAMPED AND CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A DELAY IN THE PROCEDURE DUE TO CHANGING THE TUBING OUT. THERE WAS A BLOOD LOSS OF ABOUT 10 - 15 CUBIC CENTIMETERS (CC) DURING THE PEDIATRIC CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18858873 ↗MalfunctionMar 7, 2024Break; Break
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE TUBING BROKE AT THE MANIFOLD. AS A MITIGATION, IT WAS CLAMPED AND CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A DELAY IN THE PROCEDURE DUE TO CHANGING THE TUBING OUT. THERE WAS A BLOOD LOSS OF ABOUT 10 - 15 CUBIC CENTIMETERS (CC) DURING THE PEDIATRIC CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18858403 ↗MalfunctionJan 11, 2024Break; Break
PER CLINICAL REVIEW: THIS COMPLAINT INVOLVED A PERFUSION PACK THAT HAD THE MALE CONNECTOR SHEAR OFF FROM THE MANIFOLD LINE DURING CARDIOPULMONARY BYPASS WHEN TIGHTENED. THERE WAS A BLOOD LOSS OF APPROXIMATELY 100 CUBIC CENTIMETERS (CC). THERE WAS NO HARM TO THE PATIENT AND THE SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18495859 ↗
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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