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Daily Cardiac Cooling Jacket

DAILY MEDICAL PRODUCTS, INC · Model C1116, C1123, C1130 · UDI-DI 00867673000306

DWC

510(k) clearances

9,165

Adverse events (204 deaths)

Recalls

Facilities

Description

The Daily Cardiac Cooling Jacket is a conformable heat exchanger which is placed around the heart during cardiopulmonary bypass procedures. By circulating cold physiologic saline through the jacket the heat is transferred from the heart to the solution thus reducing the heart temperature to provide myocardial preservation. The device is used as an alternative to iced slush for topical cardiac hypothermia.

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 Mycobacteria species
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 contaminated water potenti
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 Nontuberculous mycobacteria NTM
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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.