Skip to content
Recall Observatory FDA recall evidence

Device product

CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

Z-1347-2023

March 01, 2023

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
Event
Event 91775
Status
Ongoing
Classification
Class II
Quantity
4940 units
Official record key
device-enforcement:Z-1347-2023

Official wording

Reason: 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 bonded to the oxygenator port.

Code information: UDI-DI: (01)00699753450868; Lot Number AM03

Distribution pattern: US Nationwide. Belgium, Canada, Costa Rica, Thailand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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 bonded to the oxygenator port.