Reservoir, blood, cardiopulmonary bypass
FDA product code DTN · Class 2 · 16 devices · 584 reports · 20 deaths reported · 5 devices named in recalls
- Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. 3CX*FX25RWCTerumo Cardiovascular Systems Corporation · Reservoir, Blood, Cardiopulmonary Bypass1 recall11 deaths286 reports
- Affinity Fusion® BB841Medtronic, Inc. · RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS2 recalls36 reports
- NX19 Oxygenator w/4-liter reservoir; right-side outlet port 3CX*NX19RETerumo Cardiovascular Systems Corporation · Reservoir, Blood, Cardiopulmonary Bypass2 recalls27 reports
- Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. 3CX*FX15RW40CTerumo Cardiovascular Systems Corporation · Reservoir, Blood, Cardiopulmonary Bypass3 deaths79 reports
- Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. 3CX*FX15RW30CTerumo Cardiovascular Systems Corporation · Reservoir, Blood, Cardiopulmonary Bypass3 deaths57 reports
- Better-Bladder BB14Circulatory Technology Inc · RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS1 recall5 reports
- Affinity Pixie™ BBP241Medtronic, Inc. · RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS1 recall2 reports
- Affinity Fusion™ BB841Medtronic, Inc. · Reservoir, blood, cardiopulmonary bypass44 reports
- NX19 Oxygenator w/4-liter reservoir; left-side outlet port 3CX*NX19RWTerumo Cardiovascular Systems Corporation · Reservoir, Blood, Cardiopulmonary Bypass3 deaths31 reports
- NA EL240Medtronic, Inc. · RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS6 reports
- MyOtherm XP® 61399405331Medtronic, Inc. · RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS4 reports
- Affinity Fusion® BB841Medtronic, Inc. · RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS2 reports
- Bigger Better-Bladder BBB38Circulatory Technology Inc · RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS2 reports
- Affinity Fusion® BB841Medtronic, Inc. · Reservoir, blood, cardiopulmonary bypass1 report
- INSPIRE 7Sorin Group Italia Srl · Reservoir, blood, cardiopulmonary bypass1 report
- INSPIRE 7 DUALSorin Group Italia Srl · Reservoir, blood, cardiopulmonary bypass1 report