AIRCAST 10A01Recalls & reported problems
Djo, LLC · ANKLE CUFF ONLY · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912001342), received between Apr 18, 2024 and Apr 18, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Temperature Problem” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Temperature Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem
IT WAS REPORTED THAT, CUFFS WERE APPLIED AT THE SURGERY CENTER AND PATIENT EDUCATION WAS PERFORMED AT THE SURGERY CENTER AS WELL ON INSTRUCTION FOR USING THE DEVICES. THE ANKLE LEAKED AT THE TOES AND OTHER UP TOP OF ANKLE. SHE LATER DEVELOPED FROST BITE LEADING TO WOUNDS AND PLASTIC SURGERY.
Patient problems: Burn(s)
MAUDE report 19136648 ↗
Other Pack, hot or cold, water circulating devices
- DONJOY 11-0494Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-1422Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-9099Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- Micro-Temp LT 749Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- DONJOY 11-1424Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- Electri-Cool ll 767Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- T/Pump TP700Stryker Corporation · Pack, hot or cold, water circulating15 reports
- Mul-T-Pad 8002-062-026Stryker Corporation · Pack, hot or cold, water circulating7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.