Controller, Temperature, Cardiopulmonary Bypass
FDA product code DWC · Class II (moderate risk) · 21 CFR 870.4250 · Cardiovascular
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
30510(k) clearances
0PMA approvals
52recalls
Manufacturers
- Daily Medical Products, Inc. 5
- Gambro, Inc. 2
- Livanova Deutschland, GmbH 2
- Sorin Group Deutschland GmbH 2
- 3M Health Care, Sarns 2
- OriGen Biomedical, Inc. 1
- Shiley, Inc. 1
- Spectrum Medical , Ltd. 1
- Cincinnati Sub-Zero Products Inc 1
- CardioQuip, LLC 1
- Terumo Cardiovascular Systems Corporation 1
- Sams, Inc. 1
- Jostra AG 1
- Minntech Corp. 1
- Seabrook Medical Systems, Inc. 1
- Alpha Omega , Ltd. 1
- Jostra Bentley 1
- Daily Medical, Inc. 1
- Polystan C/O Vitalcor, Inc. 1
- Buckman Co., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220635 | Heater-Cooler System 3TDWC · Traditional | Livanova Deutschland, GmbH | 11/16/2022SE |
| K212657 | Quantum Heater-CoolerDWC · Traditional | Spectrum Medical , Ltd. | 05/06/2022SE |
| K191402 | Heater-Cooler System 3TDWC · Traditional | Livanova Deutschland, GmbH | 02/25/2020SE |
| K140012 | Sorin FlexthermDWC · Special | Sorin Group Deutschland GmbH | 01/31/2014SE |
| K130300 | Heater-Cooler Unit Hcu 40DWC · Traditional | Maquet Cardiopulmonary, AG | 07/01/2013SE |
| K122813 | Hemotherm Model 400CE Cooler/Heater SystemDWC · Traditional | Cincinnati Sub-Zero Products, Inc. | 12/18/2012SE |
| K102147 | Cardioquip Modular Cooler-Heater Model MCH-1000DWC · Traditional | Cardioquip Llp | 11/19/2010SE |
| K071521 | Terumo HX2 Temperature Management SystemDWC · Traditional | Terumo Cardiovascular Systems Corp. | 11/21/2007SE |
| K052601 | Stockert Heater-Cooler System 3TDWC · Traditional | Sorin Group Deutschland GmbH | 06/06/2006SE |
| K031544 | Heater Cooler Unit, Model Hcu 30DWC · Traditional | Jostra AB | 08/07/2003SE |
| K014016 | Enguard CHC Dual Reservoir Cardioplegia Heater/CoolerDWC · Traditional | Minntech Corp. | 02/01/2002SE |
| K003145 | Origen Bladder HolderDWC · Traditional | Origen Biomedical, Inc. | 04/20/2001SE |
| K001520 | Alpha Omega Dual Cooler-HeaterDWC · Traditional | Alpha Omega, Inc. | 11/22/2000SE |
| K945720 | Jostra HL-15 Modular Heart-Lung Machine (Hereinafter Called the HL-15 or the DeviceDWC · Traditional | Jostra Bentley | 03/29/1995SE |
| K896975 | Cardiac Cooling Jacket, 30% Reduced, Model CJ-220DWC · Traditional | Daily Medical Products, Inc. | 02/05/1990SE |
| K896974 | Cardiac Cooling Jacket, 8 CM, Model CJ-120DWC · Traditional | Daily Medical Products, Inc. | 02/05/1990SE |
| K896973 | Cardiac Cooling Jacket, 30% Enlarged, Model CJ-320DWC · Traditional | Daily Medical Products, Inc. | 02/05/1990SE |
| K896972 | Cardiac Cooling Jacket, 12 CM, Model CJ-520DWC · Traditional | Daily Medical Products, Inc. | 02/05/1990SE |
| K896971 | Cardiac Cooling Jacket, 8 CM, Model CJ-420DWC · Traditional | Daily Medical Products, Inc. | 02/05/1990SE |
| K896393 | Cardiac Cooling Jacked, 16 CM, Model CJ-620DWC · Traditional | Daily Medical, Inc. | 02/02/1990SE |
| K893940 | Polystan Heater-Cooler UnitDWC · Traditional | Polystan C/O Vitalcor, Inc. | 01/18/1990SE |
| K883603 | Sarns Temp. Control and Monitor System (TCM II)DWC · Traditional | 3M Health Care, Sarns | 11/03/1988SE |
| K873924 | Pti Heart-Chill Pouch/Pad Sling (Sterile)DWC · Traditional | Buckman Co., Inc. | 02/02/1988SE |
| K874927 | Pti Heart-Chill(Tm) Cardiac Insulating JacketDWC · Traditional | Pioneering Technologies, Inc. | 01/29/1988SE |
| K873699 | Ecmo-Temp (TM) Blood Warming DeviceDWC · Traditional | Seabrook Medical Systems, Inc. | 12/22/1987SE |
| K873813 | Sarns Warmer, Part #164975 and #164980DWC · Traditional | 3M Health Care, Sarns | 11/06/1987SE |
| K841402 | Temperature Control & MonitorDWC · Traditional | Sams, Inc. | 06/11/1984SE |
| K831677 | Hyper-Hypothermia Unit Hypo 10-200DWC · Traditional | Gambro, Inc. | 07/18/1983SE |
| K822874 | Thermostatic Water Mixing Valve TWV10DWC · Traditional | Gambro, Inc. | 10/18/1982SE |
| K810647 | Shiley Oxygenator Thermistor ProbeDWC · Traditional | Shiley, Inc. | 04/03/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0566-2024 Class II | CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16AThere is the potential that cooler-heater devices may contain bacterial contamination which could result in… | CardioQuip, LLC | 10/24/2023Open, Classified |
| Z-0565-2024 Class II | CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16AThere is the potential that cooler-heater devices may contain bacterial contamination which could result in… | CardioQuip, LLC | 10/24/2023Open, Classified |
| Z-0439-2024 Class II | CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16AThere is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater… | CardioQuip, LLC | 10/19/2023Open, Classified |
| Z-0438-2024 Class II | CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16AThere is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater… | CardioQuip, LLC | 10/19/2023Open, Classified |
| Z-0073-2024 Class II | 3T Heater Cooler System, REF: 16-02-85The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for… | LivaNova Deutschland GmbH | 08/03/2023Open, Classified |
| Z-2140-2021 Class II | Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for…There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a… | Maquet Medical Systems USA | 07/14/2021Terminated |
| Z-0069-2022 Class II | CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI:…There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of… | CardioQuip, LLC | 06/24/2021Open, Classified |
| Z-2092-2021 Class II | Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used…There is a potential risk of device contamination and patient infection associated with the device because… | Gentherm Medical, LLC | 06/17/2021Terminated |
| Z-0038-2022 Class II | CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model:…Labeling does not include guidance for proper water-quality maintenance and device inspection for heater… | CardioQuip, LLC | 05/12/2021Open, Classified |
| Z-0037-2022 Class II | CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI:…Labeling does not include guidance for proper water-quality maintenance and device inspection for heater… | CardioQuip, LLC | 05/12/2021Open, Classified |
| Z-0036-2022 Class II | CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797…Labeling does not include guidance for proper water-quality maintenance and device inspection for heater… | CardioQuip, LLC | 05/12/2021Open, Classified |
| Z-0035-2022 Class II | CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103Labeling does not include guidance for proper water-quality maintenance and device inspection for heater… | CardioQuip, LLC | 05/12/2021Open, Classified |
| Z-1791-2021 Class II | The Sarns TCM II (system) is a source of temperature-controlled water for blood heat…Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and… | Terumo Cardiovascular Systems Corporation | 04/16/2021Terminated |
| Z-1790-2021 Class II | The Sarns Temperature Control and Monitor unit (TCM) is a source of…Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and… | Terumo Cardiovascular Systems Corporation | 04/16/2021Terminated |
| Z-1789-2021 Class II | The Terumo HX2 Temperature Management System provides temperature control of two…Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and… | Terumo Cardiovascular Systems Corporation | 04/16/2021Terminated |
| Z-1498-2020 Class II | LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to…The firm is providing validated cleaning and disinfection instructions in their revised operating… | LivaNova USA Inc. | 02/24/2020Terminated |
| Z-0825-2019 Class II | Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM…Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the… | Cincinnati Sub-Zero Products LLC, a… | 12/19/2018Terminated |
| Z-0220-2020 Class II | SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The…The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to… | LivaNova USA Inc. | 11/01/2018Terminated |
| Z-1099-2019 Class II | SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin…For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM). | LivaNova USA Inc. | 09/14/2018Terminated |
| Z-0063-2019 Class II | Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir…Potential for membrane (control panel) switch errors leading to an inability of the device to change control… | Cincinnati Sub-Zero Products LLC, a… | 09/04/2018Terminated |
| Z-1901-2018 Class II | Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #:…Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert… | LivaNova USA | 04/20/2018Terminated |
| Z-1418-2018 Class II | Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI…Update to cooler-heater cleaning instructions. | Terumo Cardiovascular Systems Corporation | 03/16/2018Terminated |
| Z-1417-2018 Class II | Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring…Update to cooler-heater cleaning instructions. | Terumo Cardiovascular Systems Corporation | 03/16/2018Terminated |
| Z-1416-2018 Class II | Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature…Update to cooler-heater cleaning instructions. | Terumo Cardiovascular Systems Corporation | 03/16/2018Terminated |
| Z-0629-2018 Class II | Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A…Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to… | Cincinnati Sub-Zero Products LLC | 11/27/2017Terminated |
| Z-2776-2017 Class II | STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 HzPlastic heat exchanger fibers separating the blood compartment from the water compartment in certain… | Sorin Group USA, Inc. | 06/30/2017Terminated |
| Z-2775-2017 Class II | STOCKERT Heater-Cooler System 3T, 120V/60 HzPlastic heat exchanger fibers separating the blood compartment from the water compartment in certain… | Sorin Group USA, Inc. | 06/30/2017Terminated |
| Z-2774-2017 Class II | STOCKERT Heater-Cooler System 3T, 127V/60 HzPlastic heat exchanger fibers separating the blood compartment from the water compartment in certain… | Sorin Group USA, Inc. | 06/30/2017Terminated |
| Z-2773-2017 Class II | STOCKERT Heater-Cooler System 3T, 208V/60 HzPlastic heat exchanger fibers separating the blood compartment from the water compartment in certain… | Sorin Group USA, Inc. | 06/30/2017Terminated |
| Z-2772-2017 Class II | STOCKERT Heater-Cooler System 3T, 240V/60 HzPlastic heat exchanger fibers separating the blood compartment from the water compartment in certain… | Sorin Group USA, Inc. | 06/30/2017Terminated |
| Z-2771-2017 Class II | STOCKERT Heater-Cooler System 3T, 230 VPlastic heat exchanger fibers separating the blood compartment from the water compartment in certain… | Sorin Group USA, Inc. | 06/30/2017Terminated |
| Z-1825-2017 Class II | Hemotherm CE, model 400CE, Heater-Cooling DeviceImproperly rated fuses were used in the manufacture of the device. | Cincinnati Sub-Zero Products Inc | 03/09/2017Terminated |
| Z-0348-2017 Class II | Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies…There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a… | Maquet Cardiovascular Us Sales, Llc | 09/27/2016Terminated |
| Z-2210-2016 Class II | Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a…Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due… | Terumo Cardiovascular Systems Corporation | 06/08/2016Terminated |
| Z-2209-2016 Class II | Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a…Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due… | Terumo Cardiovascular Systems Corporation | 06/08/2016Terminated |
| Z-2208-2016 Class II | Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of…Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due… | Terumo Cardiovascular Systems Corporation | 06/08/2016Terminated |
| Z-2207-2016 Class II | HX2" Temperature Management Systems; The Terumo HX2" Temperature Management System…Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due… | Terumo Cardiovascular Systems Corporation | 06/08/2016Terminated |
| Z-0589-2016 Class II | Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product…Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can… | Maquet Cardiovascular Us Sales, Llc | 11/13/2015Terminated |
| Z-2081-2015 Class II | Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for…Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper… | Sorin Group USA, Inc. | 06/15/2015Terminated |
| Z-2080-2015 Class II | Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal…Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper… | Sorin Group USA, Inc. | 06/15/2015Terminated |
| Z-2079-2015 Class II | Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal…Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper… | Sorin Group USA, Inc. | 06/15/2015Terminated |
| Z-2078-2015 Class II | Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal…Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper… | Sorin Group USA, Inc. | 06/15/2015Terminated |
| Z-2077-2015 Class II | Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal…Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper… | Sorin Group USA, Inc. | 06/15/2015Terminated |
| Z-2076-2015 Class II | Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion…Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper… | Sorin Group USA, Inc. | 06/15/2015Terminated |
| Z-1116-2015 Class II | Terumo HX2 Temperature Management System provides temperature control of two independent…Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and… | Terumo Cardiovascular Systems Corporation | 02/06/2015Terminated |
| Z-0682-2017 Class II | STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item…On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and… | Sorin Group USA, Inc. | 08/01/2014Terminated |
| Z-1569-2013 Class II | Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module…Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink… | Terumo Cardiovascular Systems Corporation | 05/30/2013Terminated |
| Z-0279-2013 Class II | Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a…Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2… | Terumo Cardiovascular Systems Corporation | 10/16/2012Terminated |
| Z-0278-2013 Class II | HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a…Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2… | Terumo Cardiovascular Systems Corporation | 10/16/2012Terminated |
| Z-1186-2016 Class II | Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz…On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the… | Sorin Group USA, Inc. | 08/15/2012Terminated |