Cardiovascular Procedure Kit 71962-05Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00699753503724), received between Jul 9, 2018 and Sep 14, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak4
Patient problems
- Blood Loss4
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THAT THE HEMOCONCENTRATOR HAD A BROKEN FIBER. THE HEMOCONCENTRATOR WAS CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. MINIMAL BLOOD LOSS WAS REPORTED. ADDITIONALLY THERE WAS NO DELAY.
Patient problems: Blood Loss; No Known Impact Or Consequence To Patient
MAUDE report 7878783 ↗MalfunctionAug 29, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEMOCONCENTRATOR FIBERS APPEARED TO BE BROKEN. THE HEMOCONCENTRATOR WAS CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. MINIMAL BLOOD LOSS WAS REPORTED. THERE WAS NO DELAY NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: Blood Loss; No Consequences Or Impact To Patient
MAUDE report 7826263 ↗MalfunctionAug 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEMOCONCENTRATOR FIBERS APPEARED TO BE BROKEN. THE HEMOCONCENTRATOR WAS CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. MINIMAL BLOOD LOSS WAS REPORTED. THERE WAS NO DELAY NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: Blood Loss; No Consequences Or Impact To Patient
MAUDE report 7786849 ↗MalfunctionJul 9, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT DURING A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HPH400 HEMOCONCENTRATOR APPEARED TO HAVE A BROKEN FIBERS. THE HEMOCONCENTRATOR WAS CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. MINIMAL BLOOD LOSS WAS REPORTED. THERE WAS NO DELAY NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: Blood Loss; No Consequences Or Impact To Patient
MAUDE report 7670807 ↗
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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