Drug & Device Safety Atlas

FDA recall record · openFDA

Terumo Cardiovascular Systems Corporation

6 FDA recalls on record (2023–2025) — 6 device. 6 still ongoing.

0
Class I (most serious)
6
Class II
0
Class III
6
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxyg 3
Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measu 1
During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscre 1
Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 1

Recalls

CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Tri Class II 2025-05-28 Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 Class II 2025-03-03 Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 6 Class II 2024-02-20 CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE Class II 2023-03-01 CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC Class II 2023-03-01 CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 Class II 2023-03-01

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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