Terumo Recalls CDI Blood Parameter Monitoring System 500 for Temperature Errors
Terumo is recalling 222 CDI Blood Parameter Monitoring System 500 devices because a faulty thermistor may cause inaccurate temperature and analyte readings.
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: The recall is classified as FDA Class II. The source explicitly states that no illnesses or injuries have been reported, but the hazard involves a risk of moderate patient injury due to inaccurate medical monitoring, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is voluntarily recalling 222 units of the CDI Blood Parameter Monitoring System 500. These devices are used for continuous, on-line monitoring of blood parameters during cardiopulmonary bypass. The recall affects specific devices distributed worldwide, including in the United States, Australia, Belgium, Canada, Japan, Singapore, and the United Arab Emirates.
The recall is due to a defect in the BPM Sensor Head Assembly's thermistor, which does not meet specification. This defect may cause inaccurate blood temperature measurements, which in turn can lead to inaccurate display values for other analytes such as potassium, pO2, pCO2, and pH. Terumo received complaints of inaccurate temperature measurements for devices distributed since November 5, 2015, including both new and recently serviced units.
There have been no reported illnesses or injuries associated with this issue. However, the FDA notes that inaccurate temperature data could lead to inappropriate patient management strategies, potentially resulting in prolonged time on bypass, excessive hyperthermia or hypothermia, or moderate patient injury. Users should contact Terumo Cardiovascular Systems Corporation for instructions on how to resolve the issue.
The recalled product
- Product
- CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hemato
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 222
Distribution
Distributed nationwide across the United States.
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