Kool Kit® 900Recalls & reported problems
Gentherm Medical, LLC · Thermal Regulating System · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20613031829003), received between Sep 4, 2025 and Sep 4, 2025 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Tissue Breakdown2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTS THEY HAVE HAD SOME ISSUES RECENTLY WHERE TWO DIFFERENT PATIENTS DEVELOPED SOME PRESSURE INJURIES (BLISTER) TO THEIR SHOULDER BLADE AND BOTH WERE WEARING THE PATIENT VESTS FROM THE KOOL KITS. SECOND EVENT.
Patient problems: Tissue Breakdown
MAUDE report 22963231 ↗InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTS THEY HAVE HAD SOME ISSUES RECENTLY WHERE TWO DIFFERENT PATIENTS DEVELOPED SOME PRESSURE INJURIES (BLISTER) TO THEIR SHOULDER BLADE AND BOTH WERE WEARING THE PATIENT VESTS FROM THE KOOL KITS.
Patient problems: Tissue Breakdown
MAUDE report 22963207 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.