Oxygenator, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4350
Recent MDR events
10,612 adverse event reports on file
- CAPIOX FX25Jul 31, 2026MalfunctionTerumo Corporation, Ashitaka9681834-2026-00159
- CAPIOX FX25Jul 31, 2026InjuryTerumo Corporation, Ashitaka9681834-2026-00161
- Inspire OxygenatorJul 31, 2026InjurySorin Group Italia9680841-2026-900025
- FUSION HOLLOW FIBER OXYGENATORJul 31, 2026MalfunctionPerfusion Systems2184009-2026-01244
- FUSION HOLLOW FIBER OXYGENATORJul 30, 2026MalfunctionPerfusion Systems2184009-2026-01183
- FUSION HOLLOW FIBER OXYGENATORJul 30, 2026MalfunctionPerfusion Systems2184009-2026-01184
- FUSION HOLLOW FIBER OXYGENATORJul 30, 2026MalfunctionPerfusion Systems2184009-2026-01185
- AFFINITY NT BALANCEJul 30, 2026MalfunctionPerfusion Systems2184009-2026-01186
- AFFINITY NT BALANCEJul 30, 2026MalfunctionPerfusion Systems2184009-2026-01187
- Affinity Pixie Pediatric Hollow Fiber OxygenatorJul 30, 2026MalfunctionPerfusion Systems2184009-2026-01188
Event type breakdown
Recalls
107 recall events for this product code
- Medtronic Perfusion SystemsOpen, ClassifiedNov 10, 2025
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Z-0487-2026 · View FDA record ↗ - Maquet Medical Systems USAOpen, ClassifiedFeb 13, 2024
Model No. BEQ-HLS 5050 USA,
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Z-1076-2024 · View FDA record ↗ - Maquet Medical Systems USAOpen, ClassifiedFeb 13, 2024
BEQ-HLS 7050 USA,
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Z-1077-2024 · View FDA record ↗ - Maquet Medical Systems USAOpen, ClassifiedMay 30, 2023
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Z-1655-2023 · View FDA record ↗ - Maquet Medical Systems USAOpen, ClassifiedMay 30, 2023
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Z-1656-2023 · View FDA record ↗ - Maquet Medical Systems USAOpen, ClassifiedMay 30, 2023
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Z-1657-2023 · View FDA record ↗ - Maquet Medical Systems USAOpen, ClassifiedMay 30, 2023
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Z-1658-2023 · View FDA record ↗ - Maquet Medical Systems USAOpen, ClassifiedMay 30, 2023
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Z-1659-2023 · View FDA record ↗ - Maquet Medical Systems USAOpen, ClassifiedMay 30, 2023
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Z-1660-2023 · View FDA record ↗ - Maquet Medical Systems USAOpen, ClassifiedMay 30, 2023
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Z-1661-2023 · View FDA record ↗
Registered firms
201 firms currently registered for this product code
Steril Verona Srl
Nogara Verona, IT
Sterigenics Us Llc
Los Angeles, CA, US
Dsv Contract Logistics
Tijuana Baja California, MX
Medtronic Perfusion Systems
Minneapolis, MN, US
Abiomed, Inc.
DANVERS, MA, US
Terumo Medical Canada, Inc.
Vaughan Ontario, CA
Terumo Corp.
SHIBUYA-KU, TOKYO, JP
Spectrum Medical Srl
Mirandola Modena, IT
Sterox Srl
Filago Bergamo, IT
Eurosets S.r.l.
Medolla Modena, IT
Medtronic Mexico S. De R.l. De Cv
Tijuana Baja California, MX
Lynx Medical Pennsylvania
ERIE, PA, US
Sterigenics U.s., Llc
Queensbury, NY, US
Midwest Sterilization Corp.
JACKSON, MO, US
Centerpiece S. De R.l De C.v (sterilization Site)
Tijuana Baja California, MX
Steril Verona Srl
Trevenzuolo Verona, IT
510(k) clearances
254 clearances for this product code
- Lifemotion Medical Technology Co., Ltd.Mar 16, 2026
K253838 · Lifemotion Disposable Membrane Oxygenator
- Spectrum Medical S.R.L.Mar 12, 2026
K240934 · Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);
- Eurosets S.R.LDec 12, 2025
K250821 · Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)
- Eurosets S.R.LNov 24, 2025
K242503 · Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
- Qura S.R.LSep 12, 2024
K231982 · Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
- Medtronic Perfusion SystemsJul 10, 2024
K240666 · Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)
- Medtronic, Inc.Jun 12, 2024
K241352 · Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
- Sorin Group Italia S.R.L.Nov 16, 2023
K231652 · D100 KIDS; D101 KIDS