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ManaCold Platinum Universal Pad 2.0

Manamed, Inc. · Model MCOLDPAD02 · UDI-DI 00810113683409

ILO Prescription

510(k) clearances

984

Adverse events (3 deaths)

Recalls

125

Facilities

Description

ManaCold Platinum 2.0 Universal Pad is a water-circulating pad that's attached to our water-circulation device used to decrease pain, swelling, and muscle spasms after surgery or injury. When the cold therapy pad is applied to the patient's injured area, it delivers continuous cold therapy through the pad. It creates an easy solution for your patients without a large mess. The device has a spill proof design to allow leak free transport in the home or clinical setting. ManaCold Platinum Unit Features: Contains a leak free cooling reservoir and 7' insulation tube Includes a controller to control water flow and usage time. ManaCold Platinum 2.0 can be used and operated by a patient or healthcare provider in a home or clinical setting Features a leak-proof lid and our most secure connectors Hand control for customized prescription Joint specific pads, all sold separately

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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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.