CDI OneView™ Monitoring System CDI754Recalls & reported problems
Terumo Cardiovascular Systems Corporation · CDI OneView™ H/S Probe · Class 2
All models of CDI OneView Monitoring System (3)
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
- 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 00886799001882), received between Jan 10, 2025 and Jan 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K234065); 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.
Reports received per month
Recalls naming this device
- Mar 3, 2025Class IIOpen, Classified
During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
Z-1492-2025 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
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.
MalfunctionJan 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
PER CLINICAL REVIEW: ON (B)(6) 2024 THE TEAM AT THE USER FACILITY EXPERIENCED A PROBLEM WITH THE BLOOD PARAMETER MONITOR (BPM) WHILE ON CARDIOPULMONARY BYPASS, WHEREBY THERE WERE INTERMITTENT VENOUS AND SATURATION VALUES 100 VENOUS SAT POST FIRST IN-VIVO AT 83. THIS COMPLAINT IS RELATED TO AN ISSUE WHERE THE THRESHOLD VALUE IN THE SIGNAL FILTER IMPLEMENTED IN THE HEMATOCRIT SATURATION (H/S) SOFTWARE WAS SET BELOW THE LEVEL OF ELECTRONIC NOISE, RESULTING IN A THRESHOLD TOO RESTRICTIVE FOR NORMAL SIGNAL VARIATION IN A CLINICAL SETTING. THIS WAS CAUSING THE H/S SATURATION OF OXYGEN (SO2) VALUE TO APPEAR AS DASHES INTERMITTENTLY. THE DEVICE WAS NOT CHANGED OUT. THERE WAS NO DELAY, NO BLOOD LOSS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21124113 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K234065. One submission often covers many models, so check the product and lot details in each record.
- Z-2018-2025 · May 28, 2025 · Open, ClassifiedCDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
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™ 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
- Quantum QWS15SSpectrum Medical Limited · 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 · 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.
How reports and recalls are matched · Editorial policy · Report an error on this page