FDA Device recall Z-2018-2025
CDI OneView System BPM Probe: Cat
- FDA Device
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of CDI OneView System BPM Probe: Cat by Terumo Cardiovascular Systems, citing 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 chang….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2018-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-28 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Reason
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.
Identifiers
| code_info | UDI-DI 00886799001889 Lot Number/Serial Number Range: B0050231-B0050240 B0050221-B0050230 B0050211-B0050219 B0050201-B0050209 B0050191-B0050200 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2018-2025%22
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