The Recall Desk
HighFDA (Devices)·Z-2018-2025·Announced 2025-07-02

CDI OneView System BPM Probe temperature sensor measurement inaccuracy

Terumo Cardiovascular Systems is recalling CDI OneView System BPM Probe units due to thermistor assembly errors that cause inaccurate temperature and blood gas measurements, potentially leading to inappropriate clinical decisions.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device that measures critical blood gas and hemodynamic parameters. Although no injuries or illnesses are reported in the source text, the hazard involves inaccurate clinical data that could lead to inappropriate medical responses, meeting the rubric criterion for high-risk products where injury has not yet been reported.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling the CDI OneView System BPM Probe (catalog numbers CDI753 and CDI753TK) due to an assembly error in the thermistor within some units. This error causes the affected probes to report inaccurate shunt sensor temperature readings.

When a probe with this defect is used without an in vivo recalibration following patient temperature changes, it may also report inaccuracy in other measured parameters, including pCO2, pO2, pH, potassium, and calculated parameters such as base excess, bicarbonate, arterial oxygen saturation, delivered oxygen, area under the curve of delivered oxygen, oxygen consumption, and oxygen extraction ratio. These parameters rely on temperature as an input variable.

Inaccurate data from affected probes may lead to inappropriate user response. A total of 28 units were distributed in the United States across California, Delaware, Hawaii, Iowa, Indiana, Michigan, North Carolina, New York, Ohio, and Washington. Seven units were distributed internationally to New Zealand. Affected units bear lot numbers B0050201 through B0050240.

Healthcare facilities using these probes should verify the lot numbers and serial numbers against the affected ranges and contact Terumo for instructions on replacement or return.

The recalled product

Product
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Blood gas/hemodynamic monitoring probe
Hazard
  • measurement-inaccuracy
  • sensor-defect

Distribution

Distributed nationwide across the United States.

Related recalls

Same category