Armada B1040-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648154522), received between May 5, 2017 and Dec 13, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Folded” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY THAT IS 90% STENOSED. THE 4.0X60MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED AT 4 ATMOSPHERES DURING THE FIRST INFLATION. NO OTHER DEVICE WAS NEEDED TO COMPLETE THE PROCEDURE. THERE WAS 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 20926600 ↗
• MalfunctionJun 26, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 4.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), THE DEVICE WAS NOTED TO HAVE A LEAK DUE TO AIR NOT GOING ALL THROUGHOUT THE BALLOON. WHEN TRYING TO PREP THE BALLOON BY SUCKING BACK ON THE BALLOON HUB WITH THE SYRINGE, IT CONSTANTLY PULLED AIR INTO THE SYRINGE. TRIED MULTIPLE TIMES INCLUDING RE-PREPARATION BUT UNSUCCESSFUL. ANOTHER SAME SIZE ARMADA 35 BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199841 ↗
• MalfunctionMay 5, 2017Inflation Problem; Folded

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON ILIAC ARTERY. A 4.0X60MM ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE LESION. AN ATTEMPT TO INFLATE THE BALLOON WAS MADE; HOWEVER, THE BALLOON DILATED IRREGULARLY AND THE POSITIONING PART WAS NOT DILATED (THE DILATED PART WAS ABOUT 10MM DISTAL TO THE POSITIONING PART). THE DEVICE WAS REMOVED AND IT WAS CONFIRMED THAT THE BALLOON WAS FOLD AT THE FRONT END PORTION AGAINST THE BALLOON MARKER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ADDITIONAL TREATMENT. 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 6549481 ↗