Armada B1050-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648154591), received between Sep 27, 2019 and Dec 30, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Deflation 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Leak/Splash; Leak/Splash

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY. DURING DILATATION OF THE ARMADA 35 BDC IN THE PATIENT, LEAKING WAS OBSERVED BETWEEN THE HUB AND SHAFT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS OBSERVED THE BALLOON CATHETER INFLATED AND HELD PRESSURE. THERE WERE NO ANOMALIES NOTED TO THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930250 ↗
• MalfunctionSep 13, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 5X20MM ARMADA 35 BALLOON WAS ADVANCED TO THE LESION WITHOUT ISSUE AND WHEN INFLATED ONCE AT NOMINAL PRESSURE, A LEAK WAS NOTED IN THE BALLOON CATHETER AREA AND THE BALLOON FAILED TO INFLATE. ANOTHER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15412708 ↗
• MalfunctionMay 25, 2021Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method; Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-CALCIFIED, NON-TORTUOUS FISTULA WITH MODERATE STENOSIS. THE 5.0X20MM ARMADA 35 BALLOON WOULD NOT INFLATE, THEN THE BALLOON SUDDENLY AND RAPIDLY INFLATED PAST BURST PRESSURE AND BURST AT AN UNKNOWN PRESSURE. A NEW UNSPECIFIED BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11879144 ↗
• MalfunctionNov 18, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-CALCIFIED, NON-TORTUOUS LEFT FOREARM FISTULA. THE 5.0X20MM ARMADA 35 BALLOON FAILED TO DEFLATE. AFTER 3-5 MINUTES OF ATTEMPTING TO DEFLATE, THE BALLOON PARTIALLY DEFLATED AND WAS REMOVED. A NEW UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY CONTINUE 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 9335517 ↗
• MalfunctionSep 27, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE 5.0X20 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION AND INFLATED; HOWEVER, THE BALLOON WOULD NOT DEFLATE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9129689 ↗