Home › Device types › DTN
Reservoir, Blood, Cardiopulmonary Bypass
FDA product code DTN · Class 2 · Cardiovascular
174
Registered devices
491
Adverse events
47
Recalls
169
510(k) clearances
Devices with this code
TRILLIUM™ AFFINITY®NT — MEDTRONIC, INC.INSPIRE — SORIN GROUP ITALIA SRLINSPIRE — SORIN GROUP ITALIA SRLAFFINITY® NT — MEDTRONIC, INC.NA — MEDTRONIC, INC.XTRA — SORIN GROUP ITALIA SRLCapiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems CorporationQUADROX-i — Maquet Cardiopulmonary AGNX19 Oxygenator w/4-liter reservoir; right-side outlet port — Terumo Cardiovascular Systems CorporationAffinity Fusion® — MEDTRONIC, INC.NA — Maquet Cardiopulmonary AGQUADROX-i — Maquet Cardiopulmonary AGQUADROX-i — Maquet Cardiopulmonary AGCapiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. — Terumo Cardiovascular Systems CorporationATR 120 Autotransfusion Reservoir — Fresenius Kabi AGXTRA — SORIN GROUP ITALIA SRLBMR — SORIN GROUP ITALIA SRLCapiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. — Terumo Cardiovascular Systems CorporationMVR™ — MEDTRONIC, INC.Capiox® SX Hollow Fiber Oxygenator with Hardshell Reservoir — Terumo Cardiovascular Systems CorporationXTRA — SORIN GROUP ITALIA SRLXTRA — SORIN GROUP ITALIA SRLCapiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems CorporationRESERVOIR — SORIN GROUP ITALIA SRL
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-18 | Maquet Medical Systems USA | 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, |
| 2021-04-27 | Circulatory Technology Inc. | The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistan |
| 2021-02-04 | Medtronic Perfusion Systems | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu |
| 2021-02-04 | Medtronic Perfusion Systems | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu |
| 2021-02-04 | Medtronic Perfusion Systems | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu |
| 2021-02-04 | Medtronic Perfusion Systems | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu |
| 2021-02-04 | Medtronic Perfusion Systems | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu |
| 2021-02-04 | Medtronic Perfusion Systems | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu |
| 2021-02-04 | Medtronic Perfusion Systems | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu |
| 2021-02-04 | Medtronic Perfusion Systems | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acu |
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