Recall Z-2018-2025— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-2018-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-28

Class II · Ongoing

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2025-05-28. It names one FDA 510(k) clearance: K234065. Product: CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit. Reason: 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..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-05-28
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K234065 — CDI OneView Monitoring SystemTerumo Cardiovascular Systems Corporation·cleared 2024-04-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.