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Kelvi KLV20003Recalls & reported problems

Hypothermia Devices, Inc. · Kelvi Knee Pro Smart Wrap · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850001185042), received between Jun 30, 2023 and Jun 30, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excessive Heating” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Excessive Heating1

Patient problems

  • Blister1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 30, 2023Excessive Heating; Excessive Heating

    AN ATHLETE WAS USING A KNEE WRAP ON THEIR THIGH AND INITIATED A CONTRAST TREATMENT WITH A TEMPERATURE SETTING OF 102 DEGREES FAHRENHEIT. DURING THE TREATMENT THE ATHLETE COMPLAINED OF THE WRAP BEING TOO HOT SO THE ATHLETIC TRAINER REMOVED THE WRAP AND INSPECTED THE AREA. THE ATHLETE"S THIGH DEVELOPED A SMALL BLISTER, NO MEDICAL TREATMENT WAS NECESSARY DUE TO THE MINOR INJURY. A REPRESENTATIVE NOTIFIED KELVI OF THE ISSUE AND RETURNED THE DEVICE TO THE MANUFACTURING SITE.

    Patient problems: Blister

    MAUDE report 17240504 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.