Home › Device types › DWC
Controller, Temperature, Cardiopulmonary Bypass
FDA product code DWC · Class 2 · Cardiovascular
87
Registered devices
9,255
Adverse events
52
Recalls
30
510(k) clearances
Devices with this code
Quantum — SPECTRUM MEDICAL LIMITEDCardioQuip Modular Cooler-Heater (MCH) — CARDIOQUIP, LLCMPS 3 Mini Prime Delivery Set w/AA w/o Line — QUEST MEDICAL INCMPS 3 Delivery Set w/AA w/106cm (10C) — QUEST MEDICAL INCSarns™ Temperature Control Module — Terumo Cardiovascular Systems CorporationMPS 3 Delivery Set w/183cm (16C) — QUEST MEDICAL INCMPS 3 Arrest Cartridge — QUEST MEDICAL INCAortic Root Transducer Interface Cable (Antegrade) — QUEST MEDICAL INCCardioQuip Dripless Hose Set 10' — CARDIOQUIP, LLCSarns™ Temperature Probe Module — Terumo Cardiovascular Systems CorporationSarns™ Temperature Control Module — Terumo Cardiovascular Systems CorporationHeart Chill Cardiac & Phrenic Insulator — GENESEE BIOMEDICAL, INC.Daily Cardiac Cooling Jacket — DAILY MEDICAL PRODUCTS, INCQuantum — SPECTRUM MEDICAL LIMITEDCardioQuip Standard Hose Set 10' with Straight HX — CARDIOQUIP, LLCMPS 3 ECG Cable — QUEST MEDICAL INCCardioQuip Dripless Hose Set 10' with 90 Connectors — CARDIOQUIP, LLCMPS 3 Blood Bypass Tubing — QUEST MEDICAL INCCardioQuip Refrigeration Module — CARDIOQUIP, LLCSarns™ Temperature Control Module — Terumo Cardiovascular Systems CorporationMPS 3 Delivery Set w/AA w/106cm (16C) — QUEST MEDICAL INCMPS 3 Console — QUEST MEDICAL INCQuantum — SPECTRUM MEDICAL LIMITEDHeater-Cooler System — LivaNova Deutschland GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-24 | CardioQuip, LLC | There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. |
| 2023-10-24 | CardioQuip, LLC | There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. |
| 2023-10-19 | CardioQuip, LLC | There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components. |
| 2023-10-19 | CardioQuip, LLC | There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components. |
| 2023-08-03 | LivaNova Deutschland GmbH | The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device. |
| 2021-07-14 | Maquet Medical Systems USA | There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including |
| 2021-06-24 | CardioQuip, LLC | There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contam |
| 2021-06-17 | Gentherm Medical, LLC | There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontubercul |
| 2021-05-12 | CardioQuip, LLC | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. |
| 2021-05-12 | CardioQuip, LLC | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. |
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