CDI OneView System BPM Probe temperature sensor measurement inaccuracy
Terumo Cardiovascular Systems is recalling CDI OneView System BPM Probe units due to thermistor assembly errors that cause inaccurate temperature and blood gas measurements, potentially leading to inappropriate clinical decisions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device that measures critical blood gas and hemodynamic parameters. Although no injuries or illnesses are reported in the source text, the hazard involves inaccurate clinical data that could lead to inappropriate medical responses, meeting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the CDI OneView System BPM Probe (catalog numbers CDI753 and CDI753TK) due to an assembly error in the thermistor within some units. This error causes the affected probes to report inaccurate shunt sensor temperature readings.
When a probe with this defect is used without an in vivo recalibration following patient temperature changes, it may also report inaccuracy in other measured parameters, including pCO2, pO2, pH, potassium, and calculated parameters such as base excess, bicarbonate, arterial oxygen saturation, delivered oxygen, area under the curve of delivered oxygen, oxygen consumption, and oxygen extraction ratio. These parameters rely on temperature as an input variable.
Inaccurate data from affected probes may lead to inappropriate user response. A total of 28 units were distributed in the United States across California, Delaware, Hawaii, Iowa, Indiana, Michigan, North Carolina, New York, Ohio, and Washington. Seven units were distributed internationally to New Zealand. Affected units bear lot numbers B0050201 through B0050240.
Healthcare facilities using these probes should verify the lot numbers and serial numbers against the affected ranges and contact Terumo for instructions on replacement or return.
The recalled product
- Product
- CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
- Manufacturer
- Terumo Cardiovascular Systems Corporation
Distribution
Related recalls
Same manufacturer · Terumo Cardiovascular Systems Corporation
See all →- HighTerumo CDI OneView Monitor Probe May Fail to Display Oxygen Saturation Data
FDA (Devices) · 2025-04-09
- HighCardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect
FDA (Devices) · 2024-04-10
- HighCAPIOX RX15 Oxygenator units recalled due to improper thermistor bonding
FDA (Devices) · 2023-04-12
- HighTerumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding
FDA (Devices) · 2023-04-12
- HighCAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding
FDA (Devices) · 2023-04-12
Same hazard · measurement inaccuracy
See all →- ModeratePhilips Tempus Pro Patient Monitor Software Update for Operational Issues
FDA (Devices) · 2025-05-14
- SevereVentilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure
FDA (Devices) · 2024-11-20
- SevereAeris EVO Ventilator May Develop Flow Sensor Fouling from Aerosols
FDA (Devices) · 2024-11-20
- SevereTrilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation
FDA (Devices) · 2024-11-20
- HighBoston Scientific AVVIGO+ Guidance System Grid Mark Display Error
FDA (Devices) · 2024-10-23