Cardiovascular Procedure Kit 75582-02Recalls & reported problems
Terumo Cardiovascular Systems Corporation
All models of Cardiovascular Procedure Kit (227)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00699753528697), received between Nov 24, 2025 and Nov 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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
- Device Misassembled During Manufacturing /Shipping1
- Inaccurate Delivery1
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.
MalfunctionNov 24, 2025Inaccurate Delivery; Device Misassembled During Manufacturing /Shipping; Inaccurate Delivery; Device Misassembled During Manufacturing /Shipping
PER CLINICAL REVIEW: THE TEAM EXPERIENCED AN ISSUE WITH THEIR TUBING PACK AND THE CARDIOPLEGIA DELIVERY CIRCUIT WITHIN IT THAT HAD THE WRONG DIAMETER TUBING SIZES IN IT. THE TUBING SIZES WERE REVERSED. THIS WAS DISCOVERED DURING CARDIOPULMONARY BYPASS (CPB). THE CARDIOPLEGIA CIRCUIT TUBING WAS NOT CHANGED OUT. THERE WAS NO HARM TO THE PATIENT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE RESULT OF THIS INCORRECT ASSEMBLY WAS THAT THE INCORRECT VOLUME AND CONCENTRATION OF CARDIOPLEGIA WAS DELIVERED TO THE PATIENT. THIS OCCURRED BECAUSE THE CUSTOMER WAS NOT AWARE OF THE TUBING DIAMETER CHANGE AND DID NOT CHANGE THE FLOW CONSTANT FACTOR ON THE ROLLER PUMP. ALSO, THE CUSTOMER WAS MOST LIKELY USING A DELNIDO CARDIOPLEGIA MIXTURE, WHICH IS DICTATED TO BE DELIVERED IN A 1:4 RATIO, THAT IS 1 PART BLOOD TO 4 PARTS CRYSTALLOID. THE RESULT WAS THAT THE PATIENT HEART WAS DIFFICULT TO ARREST, AS THE IMPROPER CONCENTRATION OF BLOOD CARDIOPLEGIA WAS DELIVERED. THUS, THE PATIENT WAS UNDERDOSED BLOOD CARDIOPLEGIA. THE CARDIOPLEGIA CIRCUIT TUBING WAS NOT RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION, HOWEVER PICTURES WERE TAKEN AND SHARED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23639392 ↗
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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