Heat-Exchanger, Cardiopulmonary Bypass
FDA product code DTR · Class II (moderate risk) · 21 CFR 870.4240 · Cardiovascular
91510(k) clearances
0PMA approvals
31recalls
Manufacturers
- Shiley, Inc. 11
- Gish Biomedical, Inc. 10
- 3M Health Care, Sarns 6
- Quest Medical, Inc. 5
- American Bentley 4
- Medtronic Vascular 4
- Electromedics, Inc. 3
- Electro-Catheter Corp. 3
- Cobe Laboratories, Inc. 3
- Medtronic, Inc. 3
- Cobe Cardiovascular, Inc. 3
- Scimed Life Systems, Inc. 3
- Bentley Laboratories, Inc. 2
- Maquet Cardiopulmonary, AG 2
- Delta Medical Industries 2
- Qura S.R.L 2
- 3M Company 2
- Texas Medical Products, Inc. 1
- Norton Texas Medical Products 1
- Honeywell, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WDTR · Traditional | Spectrum Medical S.R.L. | 03/12/2026SE |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module…DTR · Traditional | Spectrum Medical , Ltd. | 07/08/2025SE |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…DTR · Special | Sorin Group Italia S.R.L. | 05/30/2025SE |
| K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…DTR · Special | Medtronic | 02/23/2024SE |
| K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)DTR · Special | Quara S.R.L. | 04/13/2023SE |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | Qura S.R.L | 05/06/2022SE |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | Qura S.R.L | 01/10/2022SE |
| K201984 | MPS 3 ND Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 11/20/2020SE |
| K200438 | MPS 3 Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 06/19/2020SE |
| K173716 | MPS2 Myocardial Protection System ConsoleDTR · Traditional | Quest Medical, Inc. | 10/01/2018SE |
| K162774 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…DTR · Traditional | Medtronic, Inc. | 02/10/2017SE |
| K162958 | MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP…DTR · Traditional | Medtronic, Inc. | 02/01/2017SE |
| K090555 | Plegiox Cardioplegia Heat Exchanger with Softline Coating, Model Bio-Chx 30DTR · Special | Maquet Cardiopulmonary, AG | 12/23/2009SE |
| K081838 | Gish Vision Blood Cardioplegia with Ha CoatingDTR · Traditional | Gish Biomedical, Inc. | 01/26/2009SE |
| K072583 | Plegiox Cardioplegia Heat Exchanger, with Safeline Coating, Model(S) CHX30, Bsq-Chx 30DTR · Traditional | Maquet Cardiopulmonary, AG | 04/04/2008SE |
| K041979 | MPS Myocardial Protection System - MPS 2 Console, Model 5201260DTR · Special | Quest Medical, Inc. | 09/02/2004SE |
| K040355 | Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS CoatingDTR · Traditional | Gish Biomedical, Inc. | 03/15/2004SE |
| K032068 | Cardiovention Corx IOS-200 System, Model IOS-200DTR · Traditional | Cardiovention, Inc. | 08/22/2003SE |
| K021830 | Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia SystemDTR · Special | Cobe Cardiovascular, Inc. | 07/02/2002SE |
| K020106 | Vision Blood Cardioplegia System and Extracorporeal Heat ExchangerDTR · Traditional | Gish Biomedical, Inc. | 04/10/2002SE |
| K012898 | Modification to: CSC14 Blood Cardioplegia SystemDTR · Special | Cobe Cardiovascular, Inc. | 09/17/2001SE |
| K000977 | Components for Cardiovascular Procedure Kit - Heat Exchanger CoilsDTR · Traditional | Olson Medical Sales, Inc. | 03/23/2001SE |
| K003724 | Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface, Models CB41…DTR · Special | Medtronic Vascular | 12/21/2000SE |
| K991137 | Enguard PHX Cardioplegia Heat ExchangerDTR · Traditional | Minntech Corp. | 06/08/2000SE |
| K982467 | Capiox CardioplegiaDTR · Traditional | Terumo Medical Corp. | 06/23/1999SE |
| K973475 | Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr…DTR · Traditional | Medtronic Vascular | 11/20/1997SE |
| K964571 | Vision Cardioplegia Delivery SystemDTR · Traditional | Lifestream Int'L, Inc. | 08/08/1997SE |
| K962320 | S3 Cardioplegia ControlDTR · Traditional | Stoeckert Instrumente | 01/10/1997SE |
| K953838 | Myocardial Protection SystemDTR · Traditional | Quest Medical, Inc. | 03/06/1996SE |
| K944219 | Single Pass Blood Cardioplegia SPBC System ComponentsDTR · Traditional | Gish Biomedical, Inc. | 06/30/1995SE |
| K944267 | Heat Exchanger Modification for Duo and OptimaDTR · Traditional | Cobe Cardiovascular, Inc. | 04/28/1995SE |
| K934355 | Electromedics Blood Heat ExchangerDTR · Traditional | Electromedics, Inc. | 12/03/1993SE |
| K932251 | Rotator;Male-Male, Male-FemaleDTR · Traditional | Merit Medical Systems, Inc. | 08/05/1993SE |
| K931967 | HE-30 GoldDTR · Traditional | Bentley Laboratories, Inc. | 07/13/1993SE |
| K925369 | BCD Advanced Blood Carioplegia SystemsDTR · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 03/26/1993SE |
| K923311 | Conducer Heat ExchangerDTR · Traditional | 3M Health Care, Sarns | 09/18/1992SE |
| K913077 | Lancaster Cooling Jacket, Cat. Code #13500/13501DTR · Traditional | Dlp, Inc. | 01/09/1992SE |
| K913691 | Cps-Plus Cardioplegia Systems, Cat# Cps-X SeriesDTR · Traditional | Gish Biomedical, Inc. | 12/18/1991SE |
| K914742 | Myocard Protect Syst W/Blood Cardio Heat Exc/ModifDTR · Traditional | Medtronic Vascular | 12/04/1991SE |
| K905500 | Myocardial Protection SystemDTR · Traditional | Medtronic Vascular | 06/10/1991SE |
| K910923 | BCD AdvancedDTR · Traditional | Shiley, Inc. | 04/09/1991SE |
| K905568 | Topical Cooling Pad, Model 7000DTR · Traditional | Daily Medical Products, Inc. | 01/23/1991SE |
| K904171 | Scimed Cardiotherm Cardioplegia Delivery SystemDTR · Traditional | Scimed | 12/06/1990SE |
| K896807 | SPBC Series Single Pass Blood Cardioplegia SystemDTR · Traditional | Gish Biomedical, Inc. | 07/31/1990SE |
| K896020 | Extracorporeal Heat Exchanger He SeriesDTR · Traditional | Gish Biomedical, Inc. | 05/17/1990SE |
| K900640 | Modified MP-4 Cardioplegia Delivery System W/ConduDTR · Traditional | 3M Company | 04/20/1990SE |
| K897039 | Sarns Miniprime Cardioplegia Set W/Conducer(Tm)DTR · Traditional | 3M Company | 03/16/1990SE |
| K884560 | Scimed Ecmotherm(Tm) Heat ExchangerDTR · Traditional | Scimed Life Systems, Inc. | 04/03/1989SE |
| K883071 | Sarns MP4 Cardioplegia Delivery SystemDTR · Traditional | 3M Health Care, Sarns | 12/05/1988SE |
| K883439 | Intersept*Crystalloid Cardioplegia Delivery SystemDTR · Traditional | Medtronic Blood Systems, Inc. | 10/13/1988SE |
| K883332 | Mast for Basic Heater-Cooler Unit 16-09-00DTR · Traditional | Shiley, Inc. | 09/26/1988SE |
| K883331 | Basic Heater-Cooler Unit W/Mast, 115/110V 16-21-10DTR · Traditional | Shiley, Inc. | 09/26/1988SE |
| K883330 | Basic Heater-Cooler Unit, 115/100V 16-02-20DTR · Traditional | Shiley, Inc. | 09/26/1988SE |
| K880663 | Shiley BCD Plus Heat ExchangerDTR · Traditional | Shiley, Inc. | 05/11/1988SE |
| K880451 | Scimed Models P-7-14 and A-19-38 Heat ExchangersDTR · Traditional | Scimed Life Systems, Inc. | 04/28/1988SE |
| K873561 | Electromedics D1079EDTR · Traditional | Electromedics, Inc. | 11/05/1987SE |
| K870804 | Cardioplegia Heat Exchanger Model No. HE-100DTR · Traditional | American Bentley | 09/01/1987SE |
| K871774 | Ccs-Xxx, Cardioplegia Administration SetsDTR · Traditional | Gish Biomedical, Inc. | 08/03/1987SE |
| K861102 | CPS-3000 Cardioplegia ReservoirDTR · Traditional | Gish Biomedical, Inc. | 05/28/1986SE |
| K860920 | Stockert-Shiley Heater/Cooler Temperature ControlDTR · Traditional | Shiley, Inc. | 05/21/1986SE |
| K860523 | Cardio-CoolDTR · Traditional | Bio-Vascular, Inc. | 04/29/1986SE |
| K853791 | Norton Cardioplegic Quick Cooling Coil 421738-000DTR · Traditional | Norton Performance Plastics Corp. | 12/09/1985SE |
| K853516 | Sarns Retrograde Cardioplegia Delivery SystemDTR · Traditional | 3M Health Care, Sarns | 11/14/1985SE |
| K853410 | Model 492-03 Polyflex Implantable Pacing LeadDTR · Traditional | Intermedics, Inc. | 10/11/1985SE |
| K852780 | BCD Plus Blood Cardioplegia Sys(Hereaf Refer Dev)DTR · Traditional | Shiley, Inc. | 09/30/1985SE |
| K850794 | Patient Monitor Model RM-300DTR · Traditional | Honeywell, Inc. | 04/18/1985SE |
| K843983 | Myocardial InsulatorDTR · Traditional | Norton Texas Medical Products | 12/27/1984SE |
| K840256 | Cardioplegia Heat Exchanger HolderDTR · Traditional | American Bentley | 02/17/1984SE |
| K840045 | Cardioplegia Heat Exchanger HE-100DTR · Traditional | American Bentley | 02/13/1984SE |
| K833555 | Lal Test Release & Bonchek Car/JacketDTR · Traditional | Shiley, Inc. | 02/04/1984SE |
| K833662 | Cardioplegia System Ccs-Xxx SeriesDTR · Traditional | Gish Biomedical, Inc. | 12/29/1983SE |
| K832417 | Hypothermic Mycardial Protection DevDTR · Traditional | 3M Health Care, Sarns | 10/20/1983SE |
| K831157 | Blood Cardioplegia Stainless Steel CoolDTR · Traditional | American Bentley | 05/09/1983SE |
| K823451 | Clear Cardioplejia Delivery SystemDTR · Traditional | 3M Health Care, Sarns | 01/14/1983SE |
| K823533 | Jacket & SetDTR · Traditional | Shiley, Inc. | 12/30/1982SE |
| K813264 | D6ZO Disposable Heat ExchangerDTR · Traditional | Electromedics, Inc. | 07/06/1982SE |
| K812093 | Cobe Heat Exchanger Reservoir ModuleDTR · Traditional | Cobe Laboratories, Inc. | 08/13/1981SE |
| K811204 | Bronchek-Shiley Cardiac Jacket & BSC JDTR · Traditional | Shiley, Inc. | 05/21/1981SE |
| K802545 | Cardioplegic SetsDTR · Traditional | Texas Medical Products, Inc. | 01/16/1981SE |
| K802879 | Buckberg-Shiley Blood Cardioplegic Spl.DTR · Traditional | Shiley, Inc. | 12/19/1980SE |
| K802848 | Cardioplegia Cooling Syst. CCAS-2DTR · Traditional | Bentley Laboratories, Inc. | 12/11/1980SE |
| K800717 | Topical Cooling Dev. Tcd. #27-999DTR · Traditional | Cobe Laboratories, Inc. | 04/16/1980SE |
| K800377 | Cardioplegia Delivery SystemDTR · Traditional | 3M Health Care, Sarns | 03/19/1980SE |
| K791430 | Miniprime Hypothermic Heat ExchangerDTR · Traditional | Travenol Laboratories, S.A. | 08/28/1979SE |
| K790756 | Heat Exchanger CoilDTR · Traditional | Delta Medical Industries | 06/11/1979SE |
| K781764 | Pad, Cooling #27-999DTR · Traditional | Cobe Laboratories, Inc. | 12/04/1978SE |
| K781210 | Heat Exchanger, FHX-14DTR · Traditional | Delta Medical Industries | 10/10/1978SE |
| K772117 | Heat Exchanger, Disp., OmnithermDTR · Traditional | Scimed Life Systems, Inc. | 03/02/1978SE |
| K770018 | Pacing Kit, Semi-FloatingDTR · Traditional | Electro-Catheter Corp. | 01/14/1977SE |
| K770017 | Pacing Kit, TransmyocardialDTR · Traditional | Electro-Catheter Corp. | 01/14/1977SE |
| K770016 | Pacing Kit, Elecath TransthoracicDTR · Traditional | Electro-Catheter Corp. | 01/14/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1641-2023 Class II | QUADROX-i Pediatric, 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-2107-2020 Class II | Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7…Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS… | Quest Medical, Inc. | 12/17/2019Terminated |
| Z-0361-2016 Class II | Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger…The products have been found to intermittently exhibit a seal failure during use. | Quest Medical, Inc. | 10/28/2015Terminated |
| Z-1165-2014 Class II | MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is…The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia… | Maquet Cardiovascular Us Sales, Llc | 01/31/2014Terminated |
| Z-0161-2015 Class II | Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a…Defect in the luer connector can compromise the seal on the female side of the connector and the compromised… | Terumo Cardiovascular Systems Corp | 03/01/2011Terminated |
| Z-0158-2015 Class II | Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia…Defect in the luer connector can compromise the seal on the female side of the connector. and the… | Terumo Cardiovascular Systems Corp | 03/01/2011Terminated |
| Z-0156-2015 Class II | Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item…Defect in the luer connector can compromise the seal on the female side of the connector and the compromised… | Terumo Cardiovascular Systems Corp | 03/01/2011Terminated |
| Z-1924-2011 | Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software…User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles. | Quest Medical, Inc | 07/29/2010Terminated |
| Z-2617-2010 | Cardiovascular Procedure Kit X-Coated H/L pack with Cardioplegia, Item # 70067-03Medical device vent port may be occluded and prevent delivery of priming fluid. | Terumo Cardiovascular Corporation | 06/08/2010Terminated |
| Z-2616-2010 | Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component…Medical device vent port may be occluded and prevent delivery of priming fluid. | Terumo Cardiovascular Corporation | 06/08/2010Terminated |
| Z-2615-2010 | Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part…Medical device vent port may be occluded and prevent delivery of priming fluid. | Terumo Cardiovascular Corporation | 06/08/2010Terminated |
| Z-2614-2010 | Cardiovascular Procedure Kit X-Coated Pump and Table Pack, Item #71552Medical device vent port may be occluded and prevent delivery of priming fluid. | Terumo Cardiovascular Corporation | 06/08/2010Terminated |
| Z-2613-2010 | Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010Medical device vent port may be occluded and prevent delivery of priming fluid. | Terumo Cardiovascular Corporation | 06/08/2010Terminated |
| Z-2612-2010 | Sarns Cardioplegia Set with w/ PVC Coil from MP4, Item # 15501Medical device vent port may be occluded and prevent delivery of priming fluid. | Terumo Cardiovascular Corporation | 06/08/2010Terminated |
| Z-2611-2010 | Sarns Cardioplegia Set with Conducer Heat Exchanger Cplg/MP4 4:1, Item # 165720Medical device vent port may be occluded and prevent delivery of priming fluid. | Terumo Cardiovascular Corporation | 06/08/2010Terminated |
| Z-2610-2010 | Sarns Cardioplegia Set Conducer Heat Exchanger Cplg/MP4 4:1 Bridge, Item# 6375Medical device vent port may be occluded and prevent delivery of priming fluid. | Terumo Cardiovascular Corporation | 06/08/2010Terminated |
| Z-2163-2010 | Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N:…Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2162-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED HEART - LUNG PACK P/N: 70608-01Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2161-2010 | Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N: 131351-02Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2160-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PACK P/N 72846Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2159-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED MASTER PACK P/N 72790Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2158-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED PUMP AND TABLE PACK W/8:1…Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2157-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED PERFUSION PACK P/N 71934Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2156-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED HEART/LUNG FRAMEPACK P/N 71766PPVent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2155-2010 | Terumo Cardiovascular Procedure Kit Custom PERFUSION TUBING PACK P/N 71733Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2154-2010 | Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N 71546-01Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2153-2010 | Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PRESTIGE PACK P/N 71544-01Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2152-2010 | Terumo Cardiovascular Procedure Kit Custom 8:1 CARDIOPLEGIA SET P/N 70608-01Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2151-2010 | Terumo Cardiovascular Procedure Kit Custom MP4, 4:1, PRELIEF, W/RECIRC, COND / PUMP &…Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2150-2010 | Terumo Cardiovascular Procedure Kit Custom 1:1 CONDUCER/MP4 CRYSTALLOID CARDIOPLEGIA P/N…Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |
| Z-2149-2010 | Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937Vent port may be occluded and prevent delivery of fluid | Terumo Cardiovascular Systems Corp | 06/08/2010Terminated |