Armada A1030-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648155796), received between Sep 18, 2020 and Mar 20, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionMar 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCFIED LESION IN THE PROFUNDA ARTERY THAT WAS 70% STENOSED. A 3.0X40MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INTO THE ANATOMY; HOWEVER, DURING THE SECOND ATTEMPT TO INFLATE THE BALLOON AT 4MMHG CONTRAST WAS NOTED TO BE LEAKING AND THE BALLOON WAS NOTED TO BE RUPTURED. THE BDC WAS REMOVED AND ANOTHER SAME SIZE ARMADA 14 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652749 ↗
• MalfunctionDec 1, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE LEFT TIBIAL ARTERY. THE 3.0X40MM ARMADA 14 BALLOON DILATATION CATHETER WAS PRESSURIZED TO THE RATED BURST PRESSURE THEN A LEAK WAS NOTED FROM THE BLACK STRAIN RELIEF TUBING NEAR THE HUB. PRESSURE WAS INCREASED WITH THE INDEFLATOR TO MAINTAIN THE PRESSURE IN THE BALLOON. THE BALLOON ANGIOPLASTY WAS ACHIEVED WITH THIS BALLOON. 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 10925039 ↗
• MalfunctionSep 18, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE FEMORAL ARTERY. DURING INFLATION, A 3X40MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS LEAKING CONTRAST WHILE CONNECTED WITH AN UNSPECIFIED Y-CONNECTOR. AN UNSPECIFIED ARMADA 14 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 Consequences Or Impact To Patient

  MAUDE report 10556412 ↗