Armada B2040-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648155116), received between Apr 2, 2020 and Apr 21, 2025 — 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 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.

• MalfunctionApr 21, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT TO A MODERATELY CALCIFIED, MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. AFTER CROSSING AN UNSPECIFIED .035 GUIDEWIRE A 4.0X100MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED AND CROSSED THE LESION. WHEN ATTEMPTING TO INFLATE THE BALLOON TO NOMINAL PRESSURE THE BALLOON DID NOT INFLATE TO ITS COMPLETE PROFILE AS A LEAK WAS OBSERVED AT THE HUB. THE BALLOON WAS REMOVED AND A 4.0X120MM ARMADA 35 WAS USED 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 21876519 ↗
• MalfunctionSep 21, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE SUPERIOR FEMORAL ARTERY. AN ARMADA35 4X100MM BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND WAS INSERTED WITHOUT ISSUES. ONCE THE DEVICE REACHED THE TARGET LESION, THE BALLOON WAS ATTEMPTED TO BE INFLATED. HOWEVER, WHEN THE BALLOON WAS ATTEMPTED TO BE INFLATED AT NORMAL PRESSURE, THE BALLOON DID NOT FULLY EXPAND. AT THIS MOMENT, THE PHYSICIAN NOTICED THAT A LEAK OCCURRED IN THE HUB; THEREFORE, THE BALLOON CATHETER WAS REMOVED AND REPLACED WITH A SAME SIZE BALLOON CATHETER. 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 10561022 ↗
• MalfunctionApr 2, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A 4X100MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS RECEIVED BY THE CUSTOMER WITH BLOOD ON THE OUTSIDE PACKAGING. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9916678 ↗