Cardiovascular Procedure Kit 66388Recalls & reported problems
Terumo Cardiovascular Systems Corporation
All models of Cardiovascular Procedure Kit (227)
Data updated Oct 16, 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699753493261), received between Nov 26, 2025 and Nov 26, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (1 report).
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 16, 2026.
Reports received per month
Recalls naming this device
- Feb 20, 2024Open, 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
- 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 26, 2025Inaccurate Delivery; Device Misassembled During Manufacturing /Shipping; Inaccurate Delivery; Device Misassembled During Manufacturing /Shipping
PER CLINICAL REVIEW: THE ISSUE INVOLVED A TUBING PACK AND A CARDIOPLEGIA DELIVERY CIRCUIT WITHIN IT THAT HAD THE WRONG DIAMETER TUBING SIZE IN IT. THE TUBING SIZES WERE REVERSED. THE ISSUE 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 COMPLETED SUCCESSFULLY. THE CARDIOPLEGIA CIRCUIT TUBING WAS NOT RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION, HOWEVER, PICTURES WERE TAKEN AND SHARED BY THE CUSTOMER CONFIRMING THE REPORTED ISSUE. FURTHER INVESTIGATION REVEALED THAT THE 1/4-INCH TUBING WAS USED WHERE THE 1/8-INCH TUBING SHOULD HAVE BEEN AND VICE VERSA. THE CARDIOPLEGIA TUBING CIRCUIT WAS ASSEMBLED IN A 1:4 RATIO INSTEAD OF A 4:1 RATIO. THIS WAS A WORKMANSHIP ERROR, WITH PRODUCTION ASSOCIATES NOT CORRECTLY USING THE SPECIFIED DIAMETER TUBING, IDENTIFIED IN THE CUSTOMERS' SPECIFICATIONS DIAGRAM. THE RESULT OF THIS INCORRECT ASSEMBLY IS THAT THE INCORRECT VOLUME AND CONCENTRATION OF CARDIOPLEGIA WAS DELIVERED TO THE PATIENT SINCE THE CUSTOMER WAS NOT AWARE OF THE TUBING DIAMETER CHANGE AND DID NOT CHANGE THE FLOW CONSTANT FACTOR ON THE ROLLER PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23662852 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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