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AqueCool
Advanced Ambulatory, Inc. · Model 1.0 · UDI-DI 00860008048325
10
510(k) clearances
1,008
Adverse events (3 deaths)
22
Recalls
125
Facilities
Description
The AqueCool Lower Face and Neck Mask (LFAN) is a wearable water circulating face mask. It covers from below the jawline up to the top of the cheek and can provide compression. Embedded wire splints and flexible chin and ear patches allow form-fitting to each user’s face. When used in conjunction with the AqueCool Device, the mask delivers cool water within the wearable bladder, wicking excess heat away from recovering tissue. Storage Temperature < 45C
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.