Cardiovascular Procedure Kit 74921-02Recalls & reported problems
Terumo Cardiovascular Systems Corporation
All models of Cardiovascular Procedure Kit (227)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00699753499188), received between Sep 17, 2021 and Oct 28, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Feb 20, 2024Class IIOpen, Classified
Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention
Z-1401-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Component Misassembled2
- Insufficient Device Problem Information2
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2025Component Misassembled; Component Misassembled
PER CLINICAL REVIEW: THIS COMPLAINT INVOLVED TUBING PACKS AND THE CARDIOPLEGIA DELIVERY TUBING WITHIN IT. THE CARDIOPLEGIA TUBING KITS WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE FIRST ERROR WAS THAT ONE CARDIOPLEGIA DELIVERY TUBING CIRCUIT HAD THE INCORRECT TUBING DUROMETER IN IT. THE CARDIOPLEGIA CIRCUIT SHOULD HAVE BEEN ONE TUBING WITH 1/4 X 1/16, 68 DUROMETER MATED WITH ANOTHER TUBING 1/8 X 1/16. THE PACK WAS DISCOVERED WITH TUBING 1/4 X 1/16, 70 DUROMETER MATED WITH 1/8 X 1/16 TUBING. DUROMETER OF TUBING IS THE SOFTNESS OF THE TUBING AND TYPICALLY WILL NOT AFFECT THE VOLUME OF CARDIOPLEGIA DELIVERED TO THE PATIENT. IT MAY HAVE MINIMAL AFFECT TO THE CLINICIANS' ABILITY TO LOAD THE TUBING. THE SECOND ERROR WAS THAT ONE CARDIOPLEGIA DELIVERY TUBING CIRCUIT HAD THE INCORRECT WALL THICKNESS IN IT. THE CARDIOPLEGIA CIRCUIT SHOULD HAVE BEEN ONE TUBING WITH 1/4 X 1/16 THICKNESS MATED WITH ANOTHER TUBING 1/8 X 1/16 THICKNESS. THE PACK WAS DISCOVERED WITH TUBING 1/4 X 3/32 THICKNESS MATED WITH 1/8 X 1/16 THICKNESS. THE TWO VARYING THICKNESS OF TUBING WOULD MOST LIKELY AFFECT THE REQUIRED OPTIMAL OCCLUSION SETTING OF THE ROLLER PUMP. BOTH OF THESE TUBINGS ARE DOUBLE LOADED I
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410015 ↗MalfunctionOct 28, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE TUBING HAD AN INCORRECT THICKNESS. THE 1/4-INCH LINE IN THE CP SET THAT GOES IN THE ROLLER PUMP WITH THE 1/8 LINES, INSTEAD OF BEING 1/4 X 1/16 IT WAS 1/4 X 1/32. THE TEAM BELIEVED THE INCOMPATIBILITY CAUSED A DELIVERY ISSUE OF CARDIOPLEGIA DURING CPB. AS A RESULT, AN ALTERNATE PACK WAS USED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A 40-CENTIMETER (CC) BLOOD LOSS. THERE WAS NO DELAY, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23409981 ↗MalfunctionNov 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THAT ONE OF THE SUCKERS BROKE. THE SUCKER WAS CHANGED OUT, WHICH RESULTED IN A TEMPORARY DELAY IN ORDER TO REPLACE THE SUCKER. NO INFORMATION WAS PROVIDED REGARDING BLOOD LOSS. IT WAS FURTHER STATED THAT SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12760653 ↗MalfunctionOct 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THAT ONE OF THE SUCKERS BROKE. THEY STOPPED USING THE SUCKER, AND SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY REPORTED, NO BLOOD LOSS AND NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12715218 ↗MalfunctionSep 17, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE CUSTOMER REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE SUCKER IN THE PACK CAME APART AND THE PIECE HAD TO BE REMOVED FROM THE CHEST. THEY STOPPED USING THIS SUCTION WAND AND COMPLETED THE SURGERY WITHOUT INCIDENT. THE PRODUCT WAS NOT CHANGED OUT AND SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY REPORTED, NO BLOOD LOSS AND NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12486915 ↗
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 · each recall links to the FDA recall notice
- 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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