Terumo Cardiovascular Systems recalls
5 official recalls and safety alerts involving Terumo Cardiovascular Systems since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Terumo Cardiovascular Systems or the relevant agency.
- 2025-07-02
USTerumo Cardiovascular Systems Corporation recalls CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial…
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…
FDA · DeviceTerumo Cardiovascular Systems CorporationUS Nationwide distribution in the states of California, Delaware, Hawaii,…Official notice →- 2025-04-09
- US
Terumo Cardiovascular Systems Corporation recalls Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
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…
FDA · DeviceTerumo Cardiovascular Systems CorporationUS: IL, TX, NY, MI, FL, NV, and Australia, New ZealandOfficial notice → - 2024-04-10
- US
Terumo Cardiovascular Systems Corporation recalls Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312…
Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or…
FDA · DeviceTerumo Cardiovascular Systems Corporationworldwide distribution - US Nationwide and the countries of Canada, Chile,…Official notice → - 2023-04-12
- US
Terumo Cardiovascular Systems Corporation recalls CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly…
FDA · DeviceTerumo Cardiovascular Systems CorporationUS Nationwide. Belgium, Canada, Costa Rica, Thailand.Official notice → - 2022-04-27
- US
Terumo Cardiovascular Systems Corp recalls Cardiovascular Procedure Kit catalog # 76645 & 73806
Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
FDA · DeviceTerumo Cardiovascular Systems CorpUS Nationwide distribution in the states of CA and IN.Official notice →