Armada B2040-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648155109), received between Apr 9, 2019 and Jan 2, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN AV FISTULA IN THE LEFT ARM. THE 4.0X80MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION AND INFLATED TO 8 ATMOSPHERES (ATM) WHEN A LEAK WAS NOTED COMING FROM THE STRAIN RELIEF BELOW THE SIDEARM. THE DEVICE WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE COMPLETED WITH A NEW DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9538158 ↗
• MalfunctionNov 15, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY THAT WAS 80% STENOSED. THE 4.0X80MM ARMADA 35 BALLOON DILATATION CATHETER WAS PRESSURIZED TO NOMINAL PRESSURE. THE BALLOON ONLY PARTIALLY INFLATED AND A LEAK WAS NOTED FROM THE HUB. A NEW 4.0X60MM ARMADA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9329855 ↗
• MalfunctionApr 9, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 4.0X80 MM ARMADA 35 WAS ADVANCED TO THE MILDLY CALCIFIED, SUPERFICIAL FEMORAL ARTERY AND RUPTURED WITH THE FIRST INFLATION BELOW NOMINAL PRESSURE. THE ARMADA WAS REMOVED FROM THE ANATOMY IN ONE PIECE WITHOUT ISSUE. ANOTHER ARMADA WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8496147 ↗