Vital Signs™ Limb-O™ Single Limb Anesthesia Breathing Circuit AGRX2XXXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752122833), received between Oct 12, 2023 and Oct 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 18, 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.

• MalfunctionOct 12, 2023Material Deformation; Material Deformation

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE THE AGRX2XXX - ANES CIRCUIT, ADULT, 60 IN LIMBO, 3L BAG INFLATES UNEVENLY. ON FOLLOW-UP, THE CUSTOMER CONFIRMED THAT WHEN THE GAS WAS INJECTED INTO THE BAG, A LUMP HAD FORMED. ALTHOUGH THE AMOUNT OF GAS SENT WAS MONITORED (PRESSURE APPLIED WAS 40 H20, WHICH IS IN A NORMAL RANGE), THEY WERE HESITANT TO USE THE BAG BECAUSE IT MAY REQUIRE A DIFFERENT FORCE COMPARED TO USING A NORMAL BAG. SURROUNDING NURSES ALSO COMMENTED THAT THE INFLATED AREA WAS SO THIN THAT THEY COULD SEE THROUGH IT, AND THEY WERE WORRIED IT WOULD BURST OR LEAK LATER ON AFTER USE. THE CUSTOMER CONFIRMED THAT NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927823 ↗