CDI™ H/S Cuvette 1/2 x 1/2 - Japan CV-6912Recalls & reported problems
Terumo Cardiovascular Systems Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00699753270114), received between Aug 1, 2023 and Aug 4, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unable to Obtain Readings” (2 reports).
4 other recalls cover devices cleared under the same FDA submission (K133658); they may or may not involve this specific model.
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
- Unable to Obtain Readings2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2023Unable to Obtain Readings; Unable to Obtain Readings
MalfunctionAug 1, 2023Unable to Obtain Readings; Unable to Obtain Readings
Recalls under the same FDA submission
These recalls involve devices cleared under K133658. One submission often covers many models, so check the product and lot details in each record.
- Z-2750-2018 · Jun 26, 2018 · TerminatedCDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure o
- Z-2751-2018 · Jun 26, 2018 · TerminatedMonitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provide
- Z-1250-2016 · Mar 14, 2016 · TerminatedCDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extrac
- Z-2742-2015 · Aug 7, 2015 · TerminatedCDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen sa
Other Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass devices
- CDI™ Shunt Sensor CDI510HTerumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass184 reports
- Quantum QLV1Spectrum Medical Limited · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass69 reports
- CDI® Blood Parameter Monitoring System 550 550AHCTTerumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass59 reports
- CDI OneView™ Monitoring System CDI754Terumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass1 recall1 report
- CDI™ Blood Parameter Monitoring System 500 500AHCTTerumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass27 reports
- Quantum QWS12ESpectrum Medical Limited · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass2 deaths27 reports
- Quantum QWSSpectrum Medical Limited · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass1 death23 reports
- CDI® Blood Parameter Monitoring System 550 550AVHCTTerumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass16 reports
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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