Armada B1040-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648154560), received between Feb 3, 2017 and Feb 3, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionFeb 3, 2017Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE 4.0 X 150 MM ARMADA 35 MM CROSSED TO THE TARGET LESION AND WAS INFLATED; HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES, CONTRAST MEDIA WAS NOTED TO BE LEAKING FROM THE JUNCTION BETWEEN THE HUB AND SHAFT. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY OR PATIENT INJURY AND A NON-ABBOTT DILATATION CATHETER WAS USED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6301737 ↗