Food, drugs, devices › Terumo Cardiovascular Systems Corporation
Device recall: CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Terumo Cardiovascular Systems Corporation (Elkton, MD) initiated this device recall on 1 Mar 2023; FDA lists 3 product records under event 91775, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Terumo Cardiovascular Systems Corporation has 73 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Terumo Cardiovascular Systems Corporation, Elkton, MD.
Reason for recall
"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."
Distribution
"US Nationwide. Belgium, Canada, Costa Rica, Thailand."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1345-2023 | CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 | 1412 units | Class II | Ongoing | 12 Apr 2023 |
| Z-1346-2023 | CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE | 84 units | Class II | Ongoing | 12 Apr 2023 |
| Z-1347-2023 | CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC | 4940 units | Class II | Ongoing | 12 Apr 2023 |
Context
Other enforcement events for Terumo Cardiovascular Systems Corporation
All 73 events for Terumo Cardiovascular Systems Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide. Belgium, Canada, Costa Rica, Thailand."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.