Oxygenator, Cardiopulmonary Bypass

FDA product code DTZ · Class 2 · 123 devices · 1,144 reports · 29 deaths reported · 50 devices named in recalls

• HLS Set BEQ-HLS 7050 USA

  Maquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass
  3 recalls13 deaths90 reports
• Affinity Fusion® BB811

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls90 reports
• HLS Set BEQ-HLS 5050 USA

  Maquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass
  3 recalls4 reports
• NA HLS Set Advanced 5.0, Small Adult, BIOLINE Coating

  Maquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS
  3 recalls0 reports
• A.M.G. PMP Sterile A.M.G. Module PMP NO T.P. Sterile

  Eurosets Srl · Oxygenator, Cardiopulmonary Bypass
  2 deaths106 reports
• CAPIOX®FX CX*FX25RW

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  2 deaths102 reports
• CAPIOX®RX CX*RX25RW

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  1 death102 reports
• NA CB7X82R4

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• NA CB7J98R7

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• NA CB7J97R8

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• NA HLS Set Advanced 7.0, Adult, BIOLINE Coating

  Maquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• QUADROX-i HMO 71000-USA #SQUADROX-i Adult + Coating, Filter

  Maquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• QUADROX-iD QUADROX-iD Adult, SOFTLINE Coating, without Filter

  Maquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• QUADROX-i HMO 50000-USA #SQUADROX-i Small Adult, no Filter

  Maquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• QUADROX-i BEQ-HMO 50000-USA #SQUADR-i Small Ado.Fi / Small Adult, BIOLINE

  Maquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• Affinity NT™ 541B

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall38 reports
• CAPIOX®FX CX*FX05RW

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  74 reports
• Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX15RE30

  Terumo Cardiovascular Systems Corporation · Oxygenator, Cardiopulmonary Bypass
  1 recall16 reports
• INSPIRE 8 PH.I.S.I.O.

  Sorin Group Italia Srl · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall6 reports
• Affinity Fusion™ CB811

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall4 reports
• INSPIRE 6 PH.I.S.I.O.

  Sorin Group Italia Srl · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall3 reports
• NA CB10W63R1

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall2 reports
• NA CB4Z27R

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB5S68R3

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB6M85R7

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB7D52R

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB6Z18R3

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB7J45R2

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB7N52R

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB7N54R1

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB6V11R9

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB5X49R17

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB5D50R2

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB7X88R8

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB6Z60R7

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB5A30R11

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB8L67R

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB7J97R5

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB5P36R10

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB3Z71R12

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB8L68R1

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB2V10R24

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB8A17R1

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB7E31R11

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB8U31R1

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB8Q44R2

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB8L67R1

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB7X82R5

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB1H18R20

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• Affinity Fusion™ CB841

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB4W67R20

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB10W64R1

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• NA CB10W65R1

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• Abiomed Breethe OXY-1 System 001-0500-001

  Breethe, Inc. · Oxygenator, Cardiopulmonary Bypass
  1 recall0 reports
• Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX25RW

  Terumo Cardiovascular Systems Corporation · Oxygenator, Cardiopulmonary Bypass
  39 reports
• CAPIOX®FX CX*FX25E

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  26 reports
• Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX25RE

  Terumo Cardiovascular Systems Corporation · Oxygenator, Cardiopulmonary Bypass
  1 death24 reports
• CAPIOX®FX CX*FX25RE

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  24 reports
• CAPIOX®FX CX*FX05RE

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  23 reports
• AMG PMP INFANT STERILE

  Eurosets Srl · Oxygenator, Cardiopulmonary Bypass
  22 reports
• Affinity® 95214

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  19 reports
• CAPIOX®FX CX*FX15E

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  19 reports
• CAPIOX®FX CX*FX15RW40

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  17 reports
• CAPIOX®FX CX*FX15RW30

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  17 reports
• CAPIOX®RX CX*RX25RE

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  17 reports
• INSPIRE 8F PH.I.S.I.O.

  Sorin Group Italia Srl · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 death16 reports
• CAPIOX®RX CX*RX05RW

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  1 death15 reports
• CAPIOX®FX CX*FX25W

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  14 reports
• CAPIOX®RX CX*RX15RW30

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  14 reports
• INSPIRE 6F PH.I.S.I.O.

  Sorin Group Italia Srl · OXYGENATOR, CARDIOPULMONARY BYPASS
  14 reports
• Affinity Fusion™ CB811

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  13 reports
• Affinity Pixie™ BBP211

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  12 reports
• Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX15RE40

  Terumo Cardiovascular Systems Corporation · Oxygenator, Cardiopulmonary Bypass
  11 reports
• Affinity Fusion™ BB811

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 deaths11 reports
• Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. 3CX*FX25RW

  Terumo Cardiovascular Systems Corporation · Oxygenator, Cardiopulmonary Bypass
  10 reports
• CAPIOX CX*FX05RWA

  Terumo Corporation · OXYGENATOR, CARDIOPULMONARY BYPASS
  10 reports
• CAPIOX®FX CX*FX15W

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  8 reports
• LILLIPUT D902 PH.I.S.I.O.

  Sorin Group Italia Srl · OXYGENATOR, CARDIOPULMONARY BYPASS
  7 reports
• NA CB9Q53R

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  5 reports
• Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX15RW30

  Terumo Cardiovascular Systems Corporation · Oxygenator, Cardiopulmonary Bypass
  5 reports
• CAPIOX CX*FX05REA

  Terumo Corporation · OXYGENATOR, CARDIOPULMONARY BYPASS
  5 reports
• CAPIOX®RX CX*RX15RW40

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  5 reports
• A.M.G.PMP PEDIATRIC A.M.G.PMP PEDIATRIC STERILE

  Eurosets Srl · Oxygenator, Cardiopulmonary Bypass
  5 reports
• Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir 3CX*RX15RW40

  Terumo Cardiovascular Systems Corporation · Oxygenator, Cardiopulmonary Bypass
  4 reports
• Affinity NT™ 95215

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 death4 reports
• CAPIOX®RX CX*RX15RE40

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  4 reports
• LILLIPUT D902

  Sorin Group Italia Srl · OXYGENATOR, CARDIOPULMONARY BYPASS
  4 reports
• KIDS D100 PHISIO

  Sorin Group Italia Srl · OXYGENATOR, CARDIOPULMONARY BYPASS
  4 reports
• Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. 3CX*FX15RE30

  Terumo Cardiovascular Systems Corporation · Oxygenator, Cardiopulmonary Bypass
  3 reports
• Capiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. 3CX*FX25RE

  Terumo Cardiovascular Systems Corporation · Oxygenator, Cardiopulmonary Bypass
  3 reports
• Affinity NT™ 95217

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  3 reports
• LILLIPUT D901 + ADAPTORS

  Sorin Group Italia Srl · OXYGENATOR, CARDIOPULMONARY BYPASS
  3 reports
• INSPIRE 8M

  Sorin Group Italia Srl · OXYGENATOR, CARDIOPULMONARY BYPASS
  3 reports
• INSPIRE 8 DUAL PH.I.S.I.O.

  Sorin Group Italia Srl · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 death3 reports
• TRILLIUM® AFFINITY NT® 95217

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 reports
• NA CB10G17R

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 reports
• NA CB11A09R3

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 reports
• Abiomed Breethe OXY-1 System 001-3300-0011

  Breethe, Inc. · Oxygenator, Cardiopulmonary Bypass
  1 death2 reports
• CAPIOX®FX CX*FX15RE40

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  2 reports
• CAPIOX®FX CX*FX15RE30

  Terumo Corporation · Oxygenator, Cardiopulmonary Bypass
  2 reports