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AIRCAST 3040Recalls & reported problems

Djo, LLC · VENAFLOW ELITE CALF CUFF · 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 00888912022408), received between May 23, 2016 and May 23, 2016 — 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

  • Pressure Sore/Ulcer1

Recent adverse event reports

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

  • InjuryMay 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    COMPLAINT RECEIVED THAT ALLEGES "PATIENT DEVELOPED GRADE 3 ULCER ON LOWER ANKLE/FOOT. POSSIBLY CAUSED BY THE TUBING ON THE CUFF ". QUESTIONNAIRE NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.

    Patient problems: Pressure Sore/Ulcer

    MAUDE report 5673697 ↗

Other SLEEVE, LIMB, COMPRESSIBLE devices

All SLEEVE, LIMB, COMPRESSIBLE devices →

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