Cardiovascular Procedure Kit 66852Recalls & reported problems
Terumo Cardiovascular Systems Corporation
Data updated Oct 13, 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 00699753513716), received between Mar 10, 2026 and Mar 10, 2026 — 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. How this data works · Data updated Oct 13, 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 · FDA record ↗
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping1
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.
MalfunctionMar 10, 2026Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CARDIOPLEGIA TUBING CONFIGURATION WAS INCORRECT. AS A RESULT, THE TUBING WAS REPLACED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS BLOOD LOSS OF AN UNKNOWN AMOUNT. THERE WAS NO DELAY, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24562489 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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