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AIRCAST 51ARecalls & reported problems

Djo, LLC · CRYO/CUFF IC COOLER · 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 00888912009102), received between Apr 10, 2018 and Apr 10, 2018 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Thrombosis1

Recent adverse event reports

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

  • InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    COMPLAINT RECEIVED THAT ALLEGES "MOTOR WILL NOT TURN OFF DOES NOT WORK INTERMITTENTLY..CUSTOMER STATED THAT IT CAUSE A BLOOD CLOT". QUESTIONNAIRE NOT RECEIVED FROM CUSTOMER OR CLINICIAN. DEVICE NOT RECEIVED MANUFACTURER AT THIS TIME.

    Patient problems: Thrombosis

    MAUDE report 7419462 ↗

Other Pack, hot or cold, water circulating devices

All Pack, hot or cold, water circulating devices →

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