Armada B2040-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648155079), received between Sep 12, 2019 and Dec 23, 2025 — classified as 3 malfunctions.

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

• MalfunctionDec 23, 2025Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  SUBSEQUENTLY, RETURNED DEVICE ANALYSIS OBSERVED THAT THE BALLOON CATHETER INFLATED AND MAINTAINED PRESSURE. THE BALLOON INFLATED WITH LIQUID, THERE WAS NO ISSUE AS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881826 ↗
• MalfunctionJun 29, 2023Material Rupture; Material Rupture

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: DURING ANGIOGRAM, THE ANGIOPLASTY BALLOON WITH A NOMINAL INFLATION RATING OF 8 ATM AND A MAXIMUM RATING OF 24 ATM BURST AT 20 ATM. BALLOON REMOVED INTACT. NO HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE RIGHT COMMON ILIAC ARTERY WITH CALCIFICATION. THE 4.00X20MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO 20 ATMOSPHERES (ATM) FOR 30 SECONDS; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NOT ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. PRIOR TO USE, THE ARMADA BDC WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226638 ↗
• MalfunctionSep 12, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION, AIR ASPIRATION, OF A 4.0 X 20 MM ARMADA 35 BALLOON CATHETER AN AIR LEAK WAS NOTED. THE BALLOON CATHETER WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED ARMADA BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9014129 ↗