—#213809

Product

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

FDA product code: DRY — Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K234065
Affected lot / code info: UDI-DI 00886799001889 Lot Number/Serial Number Range: B0050231-B0050240 B0050221-B0050230 B0050211-B0050219 B0050201-B0050209 B0050191-B0050200

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

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.

Timeline

Recall initiated: 2025-05-28
Posted by FDA: 2025-06-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.