Capiox® FX Hollow Fiber Oxygenator W Integrated Arterial Filter W Hardshell Res.
The Capiox FX15 and FX25 oxygenator assemblies exchange oxygen and carbon dioxide with blood during cardiopulmonary bypass for procedures lasting up to six hours. The listed configuration…
The Capiox FX15 and FX25 oxygenator assemblies exchange oxygen and carbon dioxide with blood during cardiopulmonary bypass for procedures lasting up to six hours. The listed configuration combines the oxygenator with an arterial filter, a heat exchanger and a hardshell blood reservoir.
Blood flows outside microporous polypropylene hollow fibers while gas flows inside them, allowing gas exchange through their walls. A 32-micron PET filter captures particles and emboli and assists air removal. Water circulated through the stainless-steel heat exchanger warms or cools the blood.
Reservoir and Flow Limits
The reservoir stores venous and cardiotomy blood and includes filtering and defoaming sections. FX15 supports up to 4L/min with a 3L reservoir or 5L/min with a 4L reservoir. FX25 supports up to 7L/min with its 4L reservoir.
1manufacturer
6catalogue numbers in this listing
12510(k) clearances naming this product code
22recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifemotion Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Terumo Cardiovascular Systems Corporation, United States |
|---|---|
| FDA product code | DTZ |
| Device type | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K140774 |
| Record published | 2015-10-01 |
| Record revised | 2020-01-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | 4 piece case of 4 |
| Distribution end date | 2018-12-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3CX*FX15RE40 | Withdrawn | |
| 3CX*FX25RE | Withdrawn | |
| 3CX*FX15RE30 | Withdrawn | |
| 3CX*FX15RW30 | Withdrawn | |
| 3CX*FX25RW | Withdrawn | |
| 3CX*FX15RW40 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | Medtronic, Inc. | 1,281 |
| Intersept™ | Medtronic, Inc. | 103 |
| Inspire | Sorin Group Italia SRL | 14 |
| Capiox®fx | Terumo Corp. | 14 |
| Capiox®rx | Terumo Corp. | 13 |
| Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U | Spectrum Medical Ltd | 11 |
| Lilliput | Sorin Group Italia SRL | 11 |
| Abiomed Breethe OXY-1 System | Breethe, Inc. | 11 |
| Kids | Sorin Group Italia SRL | 8 |
| Affinity NT™ | Medtronic, Inc. | 8 |
| Affinity Fusion™ | Medtronic, Inc. | 7 |
| QUADROX-i | Maquet Cardiopulmonary GmbH | 7 |
Showing 12 of 69. All products under Oxygenator, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180950 | 2018-06-22 |
| K172071 | 2018-03-29 |
| K153213 | 2015-12-03 |
| K153140 | 2015-12-02 |
| K151791 | 2015-11-19 |
| K151389 | 2015-10-20 |
| K140774 | 2014-06-02 |
| K130333 | 2013-03-13 |
| K130359 | 2013-03-13 |
| K062381 | 2006-08-24 |
| K051997 | 2005-09-15 |
| K010443 | 2001-12-11 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-03-01 | Class II | Process control | 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 | 84 units | |
| 2023-03-01 | Class II | Process control | 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 | 1412 units | |
| 2023-03-01 | Class II | Process control | 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 | 4940 units | |
| 2020-11-11 | Class II | Labeling mix-ups | Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West) | 5,079 Total: 523 US and 4,556 OUS | 2021-11-22 |
| 2019-06-14 | Class II | Process control | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | 52units | 2020-06-11 |
| 2019-06-14 | Class II | Process control | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | 16 units | 2020-06-11 |
| 2019-06-14 | Class II | Process control | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | 78 units | 2020-06-11 |
| 2019-06-14 | Class II | Process control | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | 123 units | 2020-06-11 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 10 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 22 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 3 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 37 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 30 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 2013-01-23 | |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 13 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 160 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 7 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 215 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 3 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 173 units | 2013-01-23 |
| 2012-04-12 | Not classified | Nonconforming Material/Component | Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss | 170 units | 2013-01-23 |
| 2010-06-28 | Not classified | Employee error | Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators. | 16 units | 2012-02-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.