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Terumo Cardiovascular Systems Corporation FDA Recalls
11 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe TriClass IIMay 28, 2025Due to an error in assembly of the thermistor within some un |
| Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754Class IIMar 3, 2025During some clinical cases, it has been observed that the SO |
| Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 6Class IIFeb 20, 2024Pressure relief valve included in certain lots of cardiovasc |
| CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19REClass IIMar 1, 2023Some Capiox NX, RX and FX Oxygenators may contain an arteria |
| CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWCClass IIMar 1, 2023Some Capiox NX, RX and FX Oxygenators may contain an arteria |
| CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30Class IIMar 1, 2023Some Capiox NX, RX and FX Oxygenators may contain an arteria |
| Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188Class IIJun 8, 2021intermittent failure causes a blender initialization fault u |
| The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeaClass IIApr 16, 2021Terumo CVS has been unable to validate a cleaning protocol t |
| The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangeClass IIApr 16, 2021Terumo CVS has been unable to validate a cleaning protocol t |
| The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directlClass IIApr 16, 2021Terumo CVS has been unable to validate a cleaning protocol t |
| Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an aClass IIMar 2, 2021There is a potential for the stainless steel locking plates |