Recall Z-2018-2025 ยท DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
| Date | Jun 24, 2025 (initiated May 28, 2025) |
| Status | Open, Classified |
| 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 l |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 28 US; 7 OUS |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K234065 | CDI OneView Monitoring System Terumo Cardiovascular Systems Corporation, Apr 25, 2024 |