Home › Device types › DTN
Reservoir, Blood, Cardiopulmonary Bypass
FDA product code DTN · Class 2 · Cardiovascular
171
Registered devices
490
Adverse events
47
Recalls
169
510(k) clearances
Devices with this code
QUADROX-i — Maquet Cardiopulmonary AGXTRA — SORIN GROUP ITALIA SRLBetter-Bladder — CIRCULATORY TECHNOLOGY INCMVR™ — MEDTRONIC, INC.XTRA — SORIN GROUP ITALIA SRLCAPIOX — TERUMO CORPORATIONXTRA — SORIN GROUP ITALIA SRLXTRA — SORIN GROUP ITALIA SRLNA — MEDTRONIC, INC.XTRA — SORIN GROUP ITALIA SRLAffinity Fusion® — MEDTRONIC, INC.MVR™ — MEDTRONIC, INC.XTRA — SORIN GROUP ITALIA SRLCapiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems CorporationINSPIRE — SORIN GROUP ITALIA SRLVANGUARD — SORIN GROUP ITALIA SRLTRILLIUM™ MYOtherm™ — MEDTRONIC, INC.INSPIRE — SORIN GROUP ITALIA SRLIntersept™ — MEDTRONIC, INC.NA — Maquet Cardiopulmonary AGCapiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. — Terumo Cardiovascular Systems CorporationCapiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir — Terumo Cardiovascular Systems CorporationMACE — Maquet Cardiopulmonary AGTRILLIUM™ AFFINITY®NT — MEDTRONIC, INC.
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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