CDI OneView™ Monitoring System CDI763Recalls & reported problems
Terumo Cardiovascular Systems Corporation · CDI OneView™ Flow Sensor 3/8" x 3/32" · Class 2
All models of CDI OneView Monitoring System (3)
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 00886799001950), received between Sep 4, 2025 and Sep 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
2 other recalls 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
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.
MalfunctionSep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE BLOOD PARAMETER MONITOR (BPM) FLOW SENSOR WAS VARIABLE FROM 2.0 TO 6.5 LITERS PER MINUTE (L/MIN). AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22973929 ↗
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
- Z-1492-2025 · Mar 3, 2025 · Open, ClassifiedTerumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
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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