QL Disposable Inflation Device QL® 6015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00856877002179), received between Dec 15, 2020 and Dec 15, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Jam” (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.

• InjuryDec 15, 2020Mechanical Jam; Mechanical Jam

  THE ATRION QL6015 WAS BEING USED DURING A TAVI PROCEDURE TO PLACE A 32 MM MYVAL (MANUFACTURED BY MERIL) WITH THE DELIVERY SYSTEM NAVIGATOR ON WHICH THE INFLATION DEVICE WAS CONNECTED AND FILLED WITH CONTRAST. DURING THE PROCEDURE WHEN THE CRIMPED VALVE WAS PLACED IN THE AORTIC ANNUALS, THE LOCKING MECHANISM ON THE INFLATION DEVICE WAS RELEASED AND THE PISTON PUSHED FORWARD TO THE BOTTOM. WHEN THE OPERATOR WANTED TO PULL BACK THE PISTON, IT WAS IMPOSSIBLE TO REDRAW THE PISTON TO DEFLATE THE BALLOON IN THE DELIVERY SYSTEM. THE STAFF DID STATE THE SYSTEM WAS UNLOCKED DURING THE EPISODE. THEY DEFLATED THE BALLOON DURING THE PROCEDURE USING A STOPCOCK WITH A SYRINGE. DURING THE EVENT, THE PATIENT WENT INTO CARDIAC ARREST AND CARDIAC MASSAGE WAS PERFORMED, THE PATIENT RECOVERED FROM THE EVENT AND IS WITHOUT SYMPTOMS.

  Patient problems: Cardiac Arrest

  MAUDE report 11012411 ↗