Terumo Cardiovascular Systems Corporation: Device Recall

Recall #Z-2018-2025 · 05/28/2025

Class II: Risk

Recall Details

Recall Number: Z-2018-2025
Classification: Class II
Product Type: Device
Recalling Firm: Terumo Cardiovascular Systems Corporation
Status: Ongoing
Date Initiated: 05/28/2025
Location: Ann Arbor, MI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 28 US; 7 OUS

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.

Product Description

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

Distribution Pattern

US Nationwide distribution in the states of California, Delaware, Hawaii, Iowa, Indiana, Michigan, North Carolina, New York, Ohio, and Washington. The country of New Zealand.

Other Recalls by Terumo Cardiovascular Systems Corporation

Class II: Risk 03/03/2025

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.

View all recalls by Terumo Cardiovascular Systems Corporation →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.