Terumo Cardiovascular Systems Corporation recalls Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe

During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.

Terumo Cardiovascular issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 03/03/2025 via email. The notice explained the reason for the removal, potential hazard, and requested the following: 1. Review this Medical Device Correction and assure that all users have received notice of this issue. 2. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 3. Terumo CVS will contact users to discuss removal and correction activities. Note: Terumo CVS recommends that users continue using CDI OneView System H/S Probes while waiting for this removal

• FDA enforcement recordOfficial FDA database entry for Z-1492-2025
• FDA 510(k) clearance · K234065The device's official FDA premarket clearance record
• FDA device classification · DRYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.4330The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Terumo Cardiovascular Systems CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.