Juzo Dynamic 3511AD5SB IVRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00640095168652), received between Aug 17, 2022 and Aug 17, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryAug 17, 2022Product Quality Problem; Inadequacy of Device Shape and/or Size

  MEDICAL COMPRESSION STOCKINGS MANUFACTURED BY JUVO (MODEL 3511, TYPE AD, SIZE IV, DYNAMIC, KNEE, OT, 5 CM, SILICONE, 20-30 MMHG). A MANUFACTURING CHANGE SOMETIME AROUND OR BEFORE THIS DATE RESULTED IN THE STOCKINGS BEING MADE TOO SHORT. EXAMPLE: LENGTH MEASUREMENT FROM TOP CUFF BELOW THE KNEE TO HEEL NOW BECAME THE ENTIRE STOCKING LENGTH FROM TOP CUFF-TO-HEEL-TO-END-OF-OPEN-TOE-STOCKING (END IS SUPPOSED TO BE ALONG BALL OF FOOT FROM BIG TO LITTLE TOE). SINCE THIS REDUCTION OF SIZE, CUFF PULLS DOWN AND WEARS AT LOWER MID-CALF CAUSING EXTREME SWELLING ABOVE CUFF TO KNEE AND EXTREME PAIN DURING NORMAL 12-16 HOUR DAY WEAR TIME, AND HEEL-TO-BALL-OF-FOOT PULLS BACK TO HEEL-TO-MID-ARCH CAUSING EXTREME PAIN FROM ARCH TO AND INCLUDING TOES DUE TO EXTREME SWELLING OF END OF FOOT (ROUNDED LIKE BALLOON) AND EXTREME SWELLING OF TOES (EXTREME SWELLING OF TOES TO 2-3 TIMES NORMAL DIAMETER). THE CUFF-TO-KNEE SWELLING ALSO TURNS RED, BUT THE SWELLING OF MID-ARCH-TO-TOES TURNS RED TO PURPLE DUE TO STOPPING BLOOD FLOW AND POOLING OF BLOOD IN SWOLLEN TISSUES, REQUIRING HOURS OF HAND COMPRESSIONS OF FOOT AND UPPER CALF TO SQUEEZE OUT BLOOD WHICH IS ALMOST COAGULATED. I AM VERY AFRAID THIS WILL RESULT I

  Patient problems: Bruise/Contusion; Erythema; Pain; Swelling/ Edema

  MAUDE report 15249906 ↗