Oxygenator, Cardiopulmonary Bypass
FDA product code DTZ · Class II (moderate risk) · 21 CFR 870.4350 · Cardiovascular
254510(k) clearances
0PMA approvals
94recalls
Manufacturers
- Sorin Group Italia S.R.L. 22
- Medtronic, Inc. 16
- Maquet Cardiopulmonary, AG 13
- American Bentley 13
- Terumo Cardiovascular Systems Corporation 12
- Medtronic Vascular 12
- Shiley, Inc. 10
- Bentley Laboratories, Inc. 10
- Dideco S.P.A. 10
- Terumo Medical Corp. 10
- 3M Health Care, Sarns 9
- Cobe Cardiovascular, Inc. 8
- C.R. Bard, Inc. 7
- Terumo Corp. 6
- Scimed Life Systems, Inc. 6
- Gish Biomedical, Inc. 6
- Eurosets S.R.L 6
- Cobe Laboratories, Inc. 6
- 3M Company 4
- Minntech Corp. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253838 | Lifemotion Disposable Membrane OxygenatorDTZ · Traditional | Lifemotion Medical Technology Co., Ltd. | 03/16/2026SE |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…DTZ · Traditional | Spectrum Medical S.R.L. | 03/12/2026SE |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…DTZ · Traditional | Eurosets S.R.L | 12/12/2025SE |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)DTZ · Traditional | Eurosets S.R.L | 11/24/2025SE |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2DTZ · Traditional | Qura S.R.L | 09/12/2024SE |
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…DTZ · Traditional | Medtronic Perfusion Systems | 07/10/2024SE |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT…DTZ · Special | Medtronic, Inc. | 06/12/2024SE |
| K231652 | D100 Kids; D101 KidsDTZ · Special | Sorin Group Italia S.R.L. | 11/16/2023SE |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum…DTZ · Traditional | Qura S.R.L | 11/08/2023SE |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)DTZ · Traditional | Chalice Medical , Ltd. | 11/01/2023SE |
| K230640 | Affinity Fusion Oxygenator SystemDTZ · Special | Medtronic, Inc. | 04/06/2023SE |
| K223161 | OXY-1 SystemDTZ · Traditional | Abiomed, Inc. | 02/23/2023SE |
| K222297 | CentriMag Pre-connected PackDTZ · Traditional | Abbott | 12/01/2022SE |
| K212341 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum…DTZ · Traditional | Qura S.R.L | 01/28/2022SE |
| K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…DTZ · Traditional | Qura S.R.L | 12/17/2021SE |
| K202510 | AMG PMP InfantDTZ · Traditional | Eurosets S.R.L | 12/10/2021SE |
| K203111 | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation SystemDTZ · Traditional | Medtronic | 09/16/2021SE |
| K211495 | Eos PMPDTZ · Special | Sorin Group Italia S.R.L. | 07/12/2021SE |
| K202206 | AMG PMP PediatricDTZ · Traditional | Eurosets S.R.L | 04/01/2021SE |
| K200109 | OXY-1 SystemDTZ · Traditional | Abiomed, Inc. | 10/23/2020SE |
| K201642 | Paragon Adult Maxi PMP Oxygenator with Tubing PackDTZ · Traditional | Chalice Medical , Ltd. | 09/18/2020SE |
| K201916 | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M…DTZ · Special | Sorin Group Italia S.R.L. | 08/13/2020SE |
| K200683 | INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow…DTZ · Special | Sorin Group Italia S.R.L. | 06/12/2020SE |
| K191246 | Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)DTZ · Traditional | Chalice Medical , Ltd. | 02/28/2020SE |
| K191444 | Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance…DTZ · Traditional | Medtronic, Inc. | 09/27/2019SE |
| K191029 | Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma…DTZ · Special | Medtronic, Inc. | 05/17/2019SE |
| K190690 | INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir…DTZ · Special | Sorin Group Italia S.R.L. | 04/13/2019SE |
| K183490 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT…DTZ · Traditional | Medtronic, Inc. | 04/12/2019SE |
| K183511 | Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie…DTZ · Traditional | Medtronic, Inc. | 03/18/2019SE |
| K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19…DTZ · Traditional | Terumo Cardiovascular Systems Corporation | 06/22/2018SE |
| K172071 | Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19…DTZ · Traditional | Terumo Cardiovascular Systems Corporation | 03/29/2018SE |
| K180448 | INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated…DTZ · Special | Sorin Group Italia S.R.L. | 03/15/2018SE |
| K172984 | Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with…DTZ · Traditional | Medtronic, Inc. | 11/20/2017SE |
| K172626 | Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with…DTZ · Traditional | Medtronic, Inc. | 10/25/2017SE |
| K162896 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium BiosurfaceDTZ · Traditional | Medtronic, Inc. | 12/06/2016SE |
| K162016 | Affinity NT Oxygenator with Cortiva BioActive SurfaceDTZ · Traditional | Medtronic, Inc. | 09/21/2016SE |
| K153295 | TandemLung OxygenatorDTZ · Traditional | Cardiacassist, Inc. | 02/26/2016SE |
| K153213 | Capiox RX Hollow Fiber Oxygenator with/without Hardshell ReservoirDTZ · Special | Terumo Cardiovascular Systems Corporation | 12/03/2015SE |
| K153140 | Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/…DTZ · Special | Terumo Cardiovascular Systems Corp. | 12/02/2015SE |
| K151791 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir…DTZ · Special | Terumo Cardiovascular Systems Corporation | 11/19/2015SE |
| K151713 | Lillipup PMP, Lilliput PMP IntegratedDTZ · Traditional | Sorin Group Italia S.R.L. | 11/06/2015SE |
| K151389 | Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell…DTZ · Traditional | Terumo Cardiovascular Systems Corporation | 10/20/2015SE |
| K150489 | EOS PMP, EOS PMP IntegratedDTZ · Traditional | Sorin Group Italia S.R.L. | 06/11/2015SE |
| K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsDTZ · Traditional | Maquet Cardiopulmonary, AG | 05/07/2015SE |
| K143073 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT…DTZ · Traditional | Medtronic, Inc. | 03/25/2015SE |
| K141492 | Advanced Membrance Gas Exchange PMP Sterile (A.M.G PMP Sterile)DTZ · Traditional | Eurosets S.R.L | 02/06/2015SE |
| K142784 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…DTZ · Special | Medtronic, Inc. | 10/24/2014SE |
| K140774 | Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirDTZ · Traditional | Terumo Cardiovascular Systems Corporation | 06/02/2014SE |
| K140181 | Medos Hilite Infant OxygenatorDTZ · Special | Medos Medizintechnik AG | 02/19/2014SE |
| K140177 | Medos Hilite OxygenatorDTZ · Special | Medos Medizintechnik AG | 02/18/2014SE |
| K133261 | Medos Hilite 7000 & 7000 LT OxygenatorDTZ · Special | Medos Medizintechnik AG | 01/09/2014SE |
| K132829 | Quadrox-I, Quadrox-Id, Quadrox-Ir OxygenatorsDTZ · Special | Maquet Cardiopulmonary, AG | 10/08/2013SE |
| K130433 | Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow…DTZ · Special | Sorin Group Italia S.R.L. | 03/20/2013SE |
| K130520 | Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirDTZ · Special | Ashitaka Factory of Terumo Corp. | 03/13/2013SE |
| K130493 | Capiox RX05 Hollow Fiber Oxygenator/ReservoirDTZ · Special | Terumo Corporation | 03/13/2013SE |
| K130359 | Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir, Capiox SX25…DTZ · Special | Terumo Cardiovascular Systems Corp. | 03/13/2013SE |
| K130333 | Capix RX Hollow Fiber Oxygenator With/Without Hardshell ReservoirDTZ · Special | Terumo Cardiovascular Systems Corp. | 03/13/2013SE |
| K130280 | Capiox FX Hollow Fiber Oxygenator W/ ReservoirDTZ · Special | Terumo Corporation | 03/13/2013SE |
| K130209 | Inspire 6 Hollow Fiber Oxygenator with Integrated Hardhell Reservoir, Inspire 6F Hollow…DTZ · Special | Sorin Group Italia S.R.L. | 02/12/2013SE |
| K123314 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive SurfaceDTZ · Traditional | Medtronic, Inc. | 01/22/2013SE |
| K122827 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface Model…DTZ · Traditional | Medtronic, Inc. | 12/14/2012SE |
| K122844 | Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…DTZ · Special | Sorin Group Italia S.R.L. | 10/17/2012SE |
| K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance BiosurfaceDTZ · Traditional | Medtronic, Inc. | 09/14/2012SE |
| K122254 | Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirDTZ · Special | Sorin Group Italia S.R.L. | 08/24/2012SE |
| K121536 | Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell ReservoirDTZ · Traditional | Sorin Group Italia S.R.L. | 08/22/2012SE |
| K121909 | Inspire 6 Dual Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy…DTZ · Special | Sorin Group Italia S.R.L. | 07/26/2012SE |
| K121229 | Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated Hardshell Venous/CardiotomyDTZ · Traditional | Sorin Group Italia S.R.L. | 07/23/2012SE |
| K120185 | Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…DTZ · Traditional | Sorin Group Italia S.R.L. | 05/11/2012SE |
| K113626 | Inspire 6 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirDTZ · Traditional | Sorin Group Italia S.R.L. | 04/05/2012SE |
| K112360 | Quadrox-I Microporporous Membrane Oxgenator Series and Qudrox-Id Diffusion Membrane…DTZ · Special | Maquet Cardiopulmonary, AG | 09/15/2011SE |
| K103191 | Quadrox-I Pediatric Microporous Membrane Oxygenator with Integrated Arterial Filter with…DTZ · Traditional | Maquet Cardiopulmonary, AG | 03/08/2011SE |
| K102464 | Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with…DTZ · Traditional | Maquet Cardiopulmonary, AG | 03/04/2011SE |
| K102109 | Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy…DTZ · Traditional | Eurosets S.R.L | 02/15/2011SE |
| K101153 | Quadrox-Id Adult Diffusion Membrane Oxygenator with Softline Coating, Model: Be-Hmod…DTZ · Traditional | Maquet Cardiopulmonary, AG | 12/08/2010SE |
| K100278 | Quadrox-Id Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Models Be-Hmod…DTZ · Traditional | Maquet Cardiopulmonary, AG | 04/30/2010SE |
| K093522 | Quadrox-I Small Adult Microporous Membrane Oxygenator; W/ Bioline Coating and W/…DTZ · Special | Maquet Cardiopulmonary, AG | 12/07/2009SE |
| K090689 | Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline…DTZ · Traditional | Maquet Cardiopulmonary, AG | 10/29/2009SE |
| K092895 | Apex HP M Adult Hollow Fiber Membrane OxygenatorDTZ · Special | Sorin Group Italia S.R.L. | 10/19/2009SE |
| K090450 | Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LTDTZ · Traditional | Gish Biomedical, Inc. | 09/18/2009SE |
| K090449 | Medos Hilite Infant Oxygenator, Model 1000, 800 LTDTZ · Traditional | Gish Biomedical, Inc. | 09/18/2009SE |
| K090511 | Quadrox-I Adult Microporous Membrane Oxygenator with Bioline Coating, Model…DTZ · Special | Maquet Cardiopulmonary, AG | 06/12/2009SE |
| K082403 | Medos Hilite Oxygenator, Model 7000 & 7000 LTDTZ · Traditional | Gish Biomedical, Inc. | 05/15/2009SE |
| K082117 | Quadrox-I Adult with and Without Integrated Arterial Filter with Softline Coating…DTZ · Traditional | Maquet Cardiopulmonary, AG | 02/18/2009SE |
| K080708 | Vision Hollow Fiber Oxygenator with Ha CoatingDTZ · Traditional | Gish Biomedical, Inc. | 02/02/2009SE |
| K083021 | Apex HP M Ph.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorDTZ · Special | Sorin Group Italia S.R.L. | 10/29/2008SE |
| K073380 | Synthesis Ph.I.S.I.O. Adult Membrane Oxygenator with Integrated Areterial Filter and…DTZ · Traditional | Sorin Group Italia S.R.L. | 02/29/2008SE |
| K071774 | Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Model Be-Hmod 2000…DTZ · Traditional | Maquet Cardiopulmonary, AG | 01/23/2008SE |
| K072091 | D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell…DTZ · Abbreviated | Sorin Group Italia S.R.L. | 10/29/2007SE |
| K072362 | Novalung Surgical Lung Assist (Sla) Membrane LungDTZ · Traditional | Novalung GmbH | 10/23/2007SE |
| K071572 | Capiox FX05 Hollow Fiber Oxygenator with Integrated Arterial FilterDTZ · Traditional | Terumo Corp. | 07/23/2007SE |
| K071494 | Capiox FX15 and FX25 Hollow Fiber Oxygenator and Arterial FilterDTZ · Traditional | Terumo Corp. | 07/16/2007SE |
| K062381 | Capiox RX Oxygenator with or Without ReservoirDTZ · Traditional | Terumo Cardiovascular Systems Corp. | 08/24/2006SE |
| K061628 | Jostra Quadrox D Safeline Diffusion Membrane Oxygenator, Model Hmod 2030DTZ · Traditional | Maquet Cardiopulmonary, AG | 08/22/2006SE |
| K061031 | D 100 L001 Ph.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator with Integrated…DTZ · Special | Sorin Group Italia S.R.L. | 06/02/2006SE |
| K051997 | Capiox RX15 Hollow, Fiber Oxygenator With/Without Hardshell ReservoirDTZ · Traditional | Terumo Cardiovascular Systems Corp. | 09/15/2005SE |
| K050447 | Performa Adult Hollow Fiber Membrane OxygenatorDTZ · Special | Dideco S.R.L. | 03/08/2005SE |
| K043323 | D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirDTZ · Abbreviated | Dideco S.R.L. | 02/01/2005SE |
| K040210 | Capiox RX25 Hollow Fiber Oxygenator W/Wo Hardshell ReservoirDTZ · Traditional | Terumo Corp. | 03/03/2004SE |
| K031903 | Rapido Cut-Away Bleedback Control Valve (BBCV), Model 7568DTZ · Traditional | Guidant Corporation | 03/03/2004SE |
| K033323 | D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 Ph.I.S.I.O. Adult Hollow…DTZ · Abbreviated | Dideco S.P.A. | 01/13/2004SE |
| K031223 | Synthesis Mimesys Adult Membrane OxygenatorDTZ · Special | Dideco S.P.A. | 05/02/2003SE |
| K023381 | Vision Hollow Fiber Oxygenator with Guardian CoatingDTZ · Traditional | Gish Biomedical, Inc. | 03/31/2003SE |
| K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030DTZ · Special | Jostra AG | 02/26/2003SE |
| K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter…DTZ · Abbreviated | Dideco S.P.A. | 10/22/2002SE |
| K022115 | Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell ReservoirDTZ · Traditional | Terumo Corp. | 09/27/2002SE |
| K013038 | Safe Maxi Hollow Fiber Oxygenator, Model 016010DTZ · Traditional | Polystan A/S | 08/14/2002SE |
| K020997 | Apex Ph.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorDTZ · Special | Dideco S.P.A. | 04/04/2002SE |
| K020351 | D 903 Avant 2 Ph.I.S.I.O. Adult Hollow Fiber OxygenatorDTZ · Special | Dideco S.P.A. | 02/26/2002SE |
| K014080 | Apex Adult Hollowe Fiber OxygenatorDTZ · Special | Dideco S.P.A. | 01/08/2002SE |
| K013915 | D902 Ph.I.S.I.O Oxygenator; D920 Ph.I.S.I.O Reservoir; Dideco D736 Ph.I.S.I.O FilterDTZ · Special | Dideco S.P.A. | 12/27/2001SE |
| K010443 | Capiox SX10 Hollow Fiber Oxygenator With/Without Hardshell Reservoir with X-CoatingDTZ · Traditional | Terumo Cardiovascular Systems Corp. | 12/11/2001SE |
| K013480 | Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane OxygenatorDTZ · Special | Cobe Cardiovascular, Inc. | 11/16/2001SE |
| K004001 | Monolyth Mimesys Hollow Fiber OxygenatorDTZ · Abbreviated | Dideco | 10/04/2001SE |
| K010478 | Dideco D901 Lilliput Hollow Fiber Oxygenator with or Without Soft Venous Reservoir Bag…DTZ · Abbreviated | Dideco | 09/27/2001SE |
| K980974 | Safe MiniDTZ · Traditional | Polystan A/S | 10/13/2000SE |
| K993772 | X-Coated Capiox SX18 and SX25 Hollow Fiber Oxygenator With/ Without Detachable Hardshell…DTZ · Traditional | Terumo Medical Corp. | 06/05/2000SE |
| K001021 | Lilliput Phospholypidic Inert Surface in Oxygenation (Ph.I.S.I.O.) Infant Hollow Fibre…DTZ · Special | Dideco S.P.A. | 04/25/2000SE |
| K000255 | Cobe Smarxt Optima XP Surface Modified Hollow Fiber Membrane OxygenatorDTZ · Traditional | Cobe Cardiovascular, Inc. | 04/25/2000SE |
| K000430 | Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda Bioactive…DTZ · Special | Medtronic Vascular | 02/25/2000SE |
| K991737 | Lilliput Phospholypidic Inert Surface in Oxygenation (Ph.I.S.I.O.) Infant/Newborn Hollow…DTZ · Traditional | Dideco S.P.A. | 02/17/2000SE |
| K990103 | Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell Venous…DTZ · Traditional | Sorin Biomedical, Inc. | 11/05/1999SE |
| K991452 | Cobe Optimin Hollow Fiber Membrane OxygenatorDTZ · Traditional | Cobe Cardiovascular, Inc. | 10/07/1999SE |
| K992559 | Hollow Fiber Membrane Oygenator Quadrox Hmo 1010DTZ · Traditional | Jostra Bentley | 09/20/1999SE |
| K992910 | Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Balance…DTZ · Special | Medtronic Vascular | 09/15/1999SE |
| K984271 | Modification of Maxima Forte' Hollow Fiber Oxygenator with Balance Biocompatible Surface…DTZ · Traditional | Medtronic Vascular | 03/09/1999SE |
| K974812 | Cobe(R) CML Duo(R) with Smart(Tm) Surface Modified Membrance OxygenatorDTZ · Traditional | Cobe Cardiovascular, Inc. | 06/01/1998SE |
| K973760 | Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceDTZ · Traditional | Avecor Cardiovascular, Inc. | 02/18/1998SE |
| K974085 | Cobe Oxygenator ProductsDTZ · Traditional | Cobe Cardiovascular, Inc. | 01/27/1998SE |
| K963518 | Cobe Optima XP Hollow Fiber Membrane OxygenatorDTZ · Traditional | Cobe Cardiovascular, Inc. | 12/08/1997SE |
| K971877 | Lilliput 2 Infant Hollow Fiber OxygenatorDTZ · Traditional | Dideco S.P.A. | 10/08/1997SE |
| K964043 | Cobe Optima and Cobe CML Duo Membrane OxygenatorsDTZ · Traditional | Cobe Cardiovascular, Inc. | 09/29/1997SE |
| K961734 | Capiox 308 Hollow Fiber Oxygenator W/Integrated Heat ExchangeDTZ · Traditional | Terumo Medical Corp. | 07/07/1997SE |
| K970463 | Capiox E Hollow Fiber Oxygenator with Integrated Heat Exchanger/Arterial ReservoirDTZ · Traditional | Terumo Medical Corp. | 05/06/1997SE |
| K964967 | Biocor 200 High PerformanceoxygenatorDTZ · Traditional | Minntech Corp. | 03/06/1997SE |
| K953976 | Safe MicroDTZ · Traditional | Polystan A/S | 02/04/1997SE |
| K962641 | Maxima Forte Hollow Fiber Oxygenator with Plasma Resistant FiberDTZ · Traditional | Medtronic Vascular | 12/16/1996SE |
| K961530 | Gish Reliance Oxygenator (Model Hfo)DTZ · Traditional | Gish Biomedical, Inc. | 12/05/1996SE |
| K954850 | Bard William Harvey HF-6000 Membrane OxygenatorDTZ · Traditional | C.R. Bard, Inc. | 10/30/1996SE |
| K960074 | Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous ReservoirDTZ · Traditional | Terumo Medical Corp. | 10/16/1996SE |
| K962667 | Capiox SX25 Hollow Fiber Oxygenator with Detachable Hardshell ReservoirDTZ · Traditional | Terumo Medical Corp. | 10/07/1996SE |
| K961000 | Capiox SX18 Hollow Fiber Oxygenator with and Without Detachable Hardshell ReservoirDTZ · Traditional | Terumo Medical Corp. | 10/02/1996SE |
| K953835 | Lilliput 1 New Born Hollow Fiber OxygenatorDTZ · Traditional | Dideco S.R.L. | 03/15/1996SE |
| K951247 | Spiralgold & Spiraloxy Hollow Fiber OxygenatorsDTZ · Traditional | Baxter Healthcare Corp | 11/02/1995SE |
| K941473 | Maxima Plus Hollow Fiber OxygenatorDTZ · Traditional | Medtronic Vascular | 06/21/1995SE |
| K941653 | Sarns Turbo Membrane Oxygenator ModificationDTZ · Traditional | 3M Health Care, Sarns | 08/24/1994SE |
| K941225 | Univix Gold Membrane Oxygenation Module with Duroflo II Heparin TreatmentDTZ · Traditional | Baxter Healthcare Corp | 08/16/1994SE |
| K934292 | William Harvey HF5000 Membrane OxygenatorDTZ · Traditional | Minntech Corp. | 07/26/1994SE |
| K931444 | Plexus 2 & 3.5 Hollow Fiber OxygenatorsDTZ · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 05/27/1994SE |
| K933586 | Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive SurfaceDTZ · Traditional | Medtronic Vascular | 02/07/1994SE |
| K932252 | Affinity Hollow Fiber OxygenatorDTZ · Traditional | Avecor Cardiovascular, Inc. | 11/19/1993SE |
| K926467 | Cobe Cms-Fs Membrane OxygenatorDTZ · Traditional | Cobe Cardiovascular, Inc. | 11/09/1993SE |
| K922799 | Capiox SX Hollow Fiber OxygenatorDTZ · Traditional | Terumo Medical Corp. | 09/02/1993SE |
| K926226 | Intersept Filtered Cardiotomy ReservoirDTZ · Traditional | Medtronic Vascular | 06/22/1993SE |
| K925076 | Sarns Turbo Membrane Oxygena. W/Int. Cardiotomy R.DTZ · Traditional | 3M Health Care, Sarns | 06/07/1993SE |
| K925075 | Sarns Turbo Membrane Oxygena. W/Int. ReservoirDTZ · Traditional | 3M Health Care, Sarns | 06/07/1993SE |
| K923272 | Cobe Cms-Hf Hollow Fiber Membrane OxygenatorDTZ · Traditional | Cobe Laboratories, Inc. | 05/11/1993SE |
| K925626 | Maxima Plus Hollow Fiber OxygenatorDTZ · Traditional | Medtronic Vascular | 02/05/1993SE |
| K922933 | Sorin Monolyrh Integrated Membrane LungDTZ · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 11/30/1992SE |
| K920889 | Minimax(R)/Maxima(R) Hollow Fiber OxygenatorsDTZ · Traditional | Medtronic Vascular | 09/15/1992SE |
| K912082 | Safe IIDTZ · Traditional | Polystan A/S | 12/04/1991SE |
| K912079 | Sarns Smoc Membrane Oxy W/Integrat Card Res,ModifyDTZ · Traditional | 3M Health Care, Sarns | 10/23/1991SE |
| K912920 | Sarns SM03 Membrane Oxygenator W/ Integrated ReserDTZ · Traditional | 3M Health Care, Ltd. | 09/25/1991SE |
| K912655 | Minimax Oxygenation SystemDTZ · Traditional | Medtronic Vascular | 09/13/1991SE |
| K897068 | Medtronic Minimax Hollow Fiber OxygenatorDTZ · Traditional | Medtronic Vascular | 08/28/1991SE |
| K912078 | Sarns SM03 Membrane Oxygenator, ModificationDTZ · Traditional | 3M Health Care, Sarns | 08/20/1991SE |
| K911227 | New Sterility Character/Sarns Oxygenator ProductsDTZ · Traditional | 3M Health Care, Sarns | 05/29/1991SE |
| K910107 | Duraflo II Heparin Oxygenator Model Univox GoldDTZ · Traditional | Baxter Healthcare Corp | 04/10/1991SE |
| K903436 | Sarns Membrane Oxgenator Part Number 9443DTZ · Traditional | 3M Health Care, Sarns | 10/19/1990SE |
| K901253 | (PBS) Portable Bypass System, Model 1000DTZ · Traditional | Bio Medicus, Inc. | 09/05/1990SE |
| K901624 | Shiley Plexus Integral Reservoir Hollow Fiber Oxy.DTZ · Traditional | Shiley, Inc. | 07/03/1990SE |
| K901250 | Plexus 2(TM) Infant Hollow Fiber OxygenatorDTZ · Traditional | Shiley, Inc. | 06/11/1990SE |
| K901249 | Plexus 3.5(TM) Pediatric Hollow Fiber OxygenatorDTZ · Traditional | Shiley, Inc. | 06/11/1990SE |
| K896978 | Closed Chest Support Circuit W/Bio-Active SurfaceDTZ · Traditional | Medtronic Vascular | 02/28/1990SE |
| K894826 | Univox W/Holders, Models Univox-Hl, HLB, HLFDTZ · Traditional | Bentley Laboratories, Inc. | 02/28/1990SE |
| K896671 | Sarns Membrane Oxygenator W/Integral Reser. #9461DTZ · Traditional | 3M Company | 02/14/1990SE |
| K892664 | Cardiopulmonary Support (CPS) SystemDTZ · Traditional | Bard Cardiosurgery Div | 02/13/1990SE |
| K893704 | SAFE-1DTZ · Traditional | Polystan C/O Vitalcor, Inc. | 12/22/1989SE |
| K895632 | Sarns Membrane Oxygenator W/Integral Cadio. 16380DTZ · Traditional | 3M Company | 12/12/1989SE |
| K893207 | Closed Chest Support CircuitDTZ · Traditional | Medtronic Blood Systems, Inc. | 12/12/1989SE |
| K895393 | Sarns Ingant Membrane OxygenatorDTZ · Traditional | 3M Company | 12/04/1989SE |
| K894970 | William Harvey HF5000 Membrane OxygenatorDTZ · Traditional | Minntech Corp. | 11/01/1989SE |
| K892641 | Bard WM Harvey HF-5700 Memb Oxygen W/Hardshell ResDTZ · Traditional | Bard Cardiosurgery Div | 11/01/1989SE |
| K894630 | Shiley Plexus(Tm) Adult Hollow Fiber OxygenatorDTZ · Traditional | Shiley, Inc. | 10/20/1989SE |
| K894103 | Scimed Ultrox True Membrane Oxygen Syst, Ultrox IIDTZ · Traditional | Scimed Life Systems, Inc. | 09/21/1989SE |
| K891687 | Extracorporeal Circuit with Bio-Active SurfaceDTZ · Traditional | Medtronic Blood Systems, Inc. | 05/31/1989SE |
| K891230 | Maxima* Hollow Fiber Oxygenator W/Filtered Reserv.DTZ · Traditional | Medtronic Blood Systems, Inc. | 05/19/1989SE |
| K890808 | Sarns Membrane Oxygenator W/Integral Cardio ReservDTZ · Traditional | 3M Company | 05/01/1989SE |
| K882892 | Membrane OxygenatorDTZ · Traditional | Baxter Bentley Laboratories, Inc. | 09/27/1988SE |
| K883054 | Scimed Ultrox True Membrane Oxy. Ultrox I & IIDTZ · Traditional | Scimed Life Systems, Inc. | 09/26/1988SE |
| K883053 | Scimed Membrane Oxygenator, Model 0600-2ADTZ · Traditional | Scimed Life Systems, Inc. | 09/26/1988SE |
| K880021 | Cobe CML3DTZ · Traditional | Cobe Laboratories, Inc. | 04/01/1988SE |
| K874841 | Integrated Membrane Oxygenator W/Cardiotomy FilterDTZ · Traditional | Bentley Laboratories, Inc. | 02/02/1988SE |
| K873923 | Integrated Membrane Oxygenator W/Cardiotomy FilterDTZ · Traditional | American Bentley | 11/06/1987SE |
| K872107 | William Harvey HF5000 Membrane OxygenatorDTZ · Traditional | Minntech Corp. | 08/28/1987SE |
| K872133 | Oxygenator Model No. Bentley 5 PlusDTZ · Traditional | American Bentley | 08/24/1987SE |
| K864235 | Bard(R) WM Harvey(R) Blood Oxygenator/Model H-1600DTZ · Traditional | C.R. Bard, Inc. | 01/02/1987SE |
| K863476 | Scimed Membrane Oxygenator System - EcmoDTZ · Traditional | Scimed Life Systems, Inc. | 11/25/1986SE |
| K863515 | Modified Sarns Oxygenator SystemDTZ · Traditional | 3M Health Care, Sarns | 11/18/1986SE |
| K863249 | Oxygenator Model No. BENTLEY-10 PlusDTZ · Traditional | American Bentley | 10/20/1986SE |
| K861641 | Heparin-Coated Extracorporeal CircuitsDTZ · Traditional | American Bentley | 09/29/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0487-2026 Class II | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated…Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet… | Medtronic Perfusion Systems | 09/12/2025Open, Classified |
| Z-1077-2024 Class II | BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with…The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to… | Maquet Medical Systems USA | 01/16/2024Open, Classified |
| Z-1076-2024 Class II | Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077.…The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to… | Maquet Medical Systems USA | 01/16/2024Open, Classified |
| Z-1662-2023 Class II | QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO…Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1661-2023 Class II | Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No.…Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1660-2023 Class II | QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO…Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1659-2023 Class II | QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO…Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1658-2023 Class II | QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No.…Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1657-2023 Class II | QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no.…Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1656-2023 Class II | QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD…Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1655-2023 Class II | QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO…Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1640-2023 Class II | QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1639-2023 Class II | BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1638-2023 Class II | QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1637-2023 Class II | QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1636-2023 Class II | BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1635-2023 Class II | BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no.…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1634-2023 Class II | HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no.…1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's… | Maquet Medical Systems USA | 05/18/2023Open, Classified |
| Z-1347-2023 Class II | CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWCSome Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded… | Terumo Cardiovascular Systems Corporation | 03/01/2023Open, Classified |
| Z-1346-2023 Class II | CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RESome Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded… | Terumo Cardiovascular Systems Corporation | 03/01/2023Open, Classified |
| Z-1345-2023 Class II | CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded… | Terumo Cardiovascular Systems Corporation | 03/01/2023Open, Classified |
| Z-1188-2023 Class II | BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS…Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to… | Maquet Medical Systems USA | 02/13/2023Open, Classified |
| Z-1028-2023 Class II | Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated…An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity… | Medtronic Perfusion Systems | 12/12/2022Open, Classified |
| Z-1027-2023 Class II | Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated…An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity… | Medtronic Perfusion Systems | 12/12/2022Open, Classified |
| Z-1026-2023 Class II | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity… | Medtronic Perfusion Systems | 12/12/2022Open, Classified |
| Z-1025-2023 Class II | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity… | Medtronic Perfusion Systems | 12/12/2022Open, Classified |
| Z-1024-2023 Class II | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity… | Medtronic Perfusion Systems | 12/12/2022Open, Classified |
| Z-1023-2023 Class II | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity… | Medtronic Perfusion Systems | 12/12/2022Open, Classified |
| Z-1767-2022 Class II | BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for…The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility… | Maquet Medical Systems USA | 07/22/2022Open, Classified |
| Z-1766-2022 Class II | BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for…The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility… | Maquet Medical Systems USA | 07/22/2022Open, Classified |
| Z-1765-2022 Class II | BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for…The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility… | Maquet Medical Systems USA | 07/22/2022Open, Classified |
| Z-1764-2022 Class II | BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for…The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility… | Maquet Medical Systems USA | 07/22/2022Open, Classified |
| Z-0550-2022 Class I | OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1…The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use… | Abiomed, Inc. | 12/14/2021Terminated |
| Z-0633-2021 Class II | HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part…The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's… | Maquet Cardiovascular Us Sales, Llc | 11/20/2020Terminated |
| Z-0632-2021 Class II | HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part…The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's… | Maquet Cardiovascular Us Sales, Llc | 11/20/2020Terminated |
| Z-0565-2021 Class II | (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC…Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West) | Terumo Cardiovascular Systems Corporation | 11/11/2020Terminated |
| Z-0677-2020 Class II | Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator…Sterile barrier system may be compromised | Getinge US Sales LLC | 11/13/2019Open, Classified |
| Z-2149-2019 Class II | Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050…The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous… | Maquet Cardiovascular Us Sales, Llc | 07/11/2019Terminated |
| Z-2104-2019 Class II | Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for…Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | Terumo Cardiovascular Systems Corporation | 06/14/2019Terminated |
| Z-2103-2019 Class II | Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan…Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | Terumo Cardiovascular Systems Corporation | 06/14/2019Terminated |
| Z-2102-2019 Class II | Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RWCapiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | Terumo Cardiovascular Systems Corporation | 06/14/2019Terminated |
| Z-2101-2019 Class II | Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RECapiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | Terumo Cardiovascular Systems Corporation | 06/14/2019Terminated |
| Z-0437-2019 Class I | QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO…There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter… | Maquet Cardiovascular Us Sales, Llc | 10/25/2018Terminated |
| Z-0436-2019 Class I | QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO…There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter… | Maquet Cardiovascular Us Sales, Llc | 10/25/2018Terminated |
| Z-2495-2020 Class II | Extra corporeal circuit with bio-active surface.Affected products failed a sterilization test. | Medtronic Perfusion Systems | 08/08/2018Terminated |
| Z-1919-2018 Class II | Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The…Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique… | LivaNova USA | 03/13/2018Terminated |
| Z-1918-2018 Class II | Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The…Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique… | LivaNova USA | 03/13/2018Terminated |
| Z-0826-2017 Class II | Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion…Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion… | Medtronic Inc | 11/16/2016Terminated |
| Z-1371-2016 Class II | QUADROX-i oxygenators Custom tubing packs for the oxygenatorMaquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to… | Maquet Cardiovascular Us Sales, Llc | 02/23/2016Terminated |
| Z-1689-2015 Class II | Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult…A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of… | Maquet Cardiovascular Us Sales, Llc | 03/05/2015Terminated |