Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe Recalled by Terumo Cardiovascular Systems Corporation Due to Due to an error in assembly of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Terumo Cardiovascular Systems Corporation directly.
Affected Products
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Quantity: 28 US; 7 OUS
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Systems Corporation has 204 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report