CDI OneView System BPM Probe recallZ-2018-2025 · Terumo Cardiovascular Systems Corporation · initiated May 28, 2025
Class II Open, Classified All recalls posted in June 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-2018-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- May 28, 2025
- Posted by the FDA
- Jun 24, 2025
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 28 US; 7 OUS
- Product code
- DRY
- FDA submissions
- K234065
- 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.
Product description
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Code information (models, lots, serial numbers)
UDI-DI 00886799001889 Lot Number/Serial Number Range: B0050231-B0050240 B0050221-B0050230 B0050211-B0050219 B0050201-B0050209 B0050191-B0050200
Other devices under the same FDA submission
3 devices cleared under K234065 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CDI OneView™ Monitoring System CDI754Terumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass1 recall1 report
- CDI OneView™ Monitoring System CDI753Terumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass4 reports
- CDI OneView™ Monitoring System CDI763Terumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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