Terumo Cardiovascular Systems Corporation recalls CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe

Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.

On May 28, 2025, firm began notifying affected consignees via Urgent Medical Device Removal letters. A Terumo Service Representative will contact each customer to discuss removal and replacement of affected devices. The firm is not recommending that customers halt use of their CDI OneView BPM Probe while waiting for removal and replacement. In the event suspected parameter inaccuracy occurs, performance of an in vivo recalibration is recommended. Per the Operator's Manual, displayed values should be verified for accuracy from another source before initial treatment.

• FDA enforcement recordOfficial FDA database entry for Z-2018-2025
• FDA 510(k) clearance · K234065The device's official FDA premarket clearance record
• FDA device classification · DRYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.4330The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Terumo Cardiovascular Systems CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.