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AqueCool
Advanced Ambulatory, Inc. · Model 1.0 · UDI-DI 00860008048301
10
510(k) clearances
984
Adverse events (3 deaths)
22
Recalls
125
Facilities
Description
The AqueCool Device, in conjunction with AqueCool masks, pumps cooled water across recovering tissue to wick away excess heat. The device is controllable between 50 and 65 Degrees Fahrenheit and utilizes a 6 foot tube set to allow the device to remain on the floor while in operation. Simple On/Off power button and temperature control knob on top of device allow user to easily adjust temperature or turn device off. The AqueCool system requires a standard 120VAC wall receptacle and 8-10oz of distilled water to operate.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | DJO, LLC | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. |
| 2026-03-19 | DJO, LLC | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. |
| 2026-03-19 | DJO, LLC | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. |
| 2026-03-19 | DJO, LLC | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. |
| 2021-11-22 | Gentherm Medical, LLC | This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads. |
| 2019-07-19 | Cincinnati Sub-Zero Products LLC, a Gentherm Company | Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage |
| 2017-11-07 | Stryker Medical Division of Stryker Corporation | The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenanc |
| 2015-01-07 | Cincinnati Sub-Zero Products Inc | Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak. |
| 2013-09-17 | DeRoyal Industries Inc | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it t |
| 2013-09-17 | DeRoyal Industries Inc | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it t |
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Get your free API keyRead the docsData 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.