Armada B1030-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648154492), received between Jan 17, 2017 and Apr 9, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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.

• MalfunctionApr 9, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A STENOSIS IN A RIGHT BRACHIAL SHUNT. A 3X40MM ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION AND INFLATED; HOWEVER, THE BALLOON DID NOT DILATE DUE TO AIR LEAKAGE FROM THE HUB. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3X40MM ARMADA 35 BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645526 ↗
• MalfunctionJul 14, 2020Break; Inflation Problem; Material Separation; Break; Inflation Problem; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN UNSPECIFIED LESION. THE 3.0X40MM ARMADA 35 BALLOON COULD NOT BE FULLY INFLATED AS THE HUB WAS CRACKED AT THE INFLATION PORT THREADING. THE BALLOON WAS USED AT NOMINAL PRESSURE AS FULL ANGIOPLASTY WAS NOT NEEDED. 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 10273040 ↗
• MalfunctionJan 17, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SHUNT PERCUTAEOUS PERIPHERAL INTERVENTION (PPI). A 3.0 X 40 MM ARMADA 35 WAS ADVANCED TO THE LESION AND INFLATED WHEN IT RUPTURED AT 7 ATMOSPHERES DURING THE FIRST INFLATION. A NEW 3.0 X 40MM ARMADA 35 WAS SUCCESSFULLY USED TO FURTHER DILATE THE LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6258699 ↗