Armada 1013466-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648208027), received between Sep 7, 2018 and Sep 13, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY THAT WAS 80% STENOSED. THE 3X200MM ARMADA 18 BALLOON WAS ADVANCED WITHOUT ISSUE TO THE LESION AND INFLATED ONCE AT 8 ATMOSPHERES WHEN IT RUPTURED. THE DEVICE WAS REMOVED. THEN A 4X200MM ARMADA 18 BALLOON WAS ADVANCED WITHOUT ISSUE TO THE LESION AND INFLATED ONCE AT 8 ATMOSPHERES WHEN IT RUPTURED. THE DEVICE WAS REMOVED. A ROTABLATOR 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 15414421 ↗
• MalfunctionJun 23, 2021Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT TIBIAL ARTERY. A 4X200MM ARMADA 18 BALLOON WAS ADVANCED TO THE LESION AND INFLATED ONCE AT 18 ATMOSPHERES (ATMS) WHEN IT RUPTURED. ANOTHER 4X60MM ARMADA 14 BALLOON WAS THEN USED BUT WHEN INFLATED ONCE IT RUPTURED AT ABOUT 4 ATMS. ANOTHER ARMADA 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 12050954 ↗
• MalfunctionNov 7, 2019Failure to Fold; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Fold; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED (CTO), HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE NOTED. THE BALLOON WAS INFLATED TO 18-22 ATMOSPHERES SEVERAL TIMES AND PULLED NEGATIVE TWICE FOR DEFLATION. WHEN ATTEMPTED TO REMOVE, THERE WAS SIGNIFICANT RESISTANCE. IT APPEARED THE BALLOON DETACHED FROM THE CATHETER AND WAS GETTING STUCK IN THE ANATOMY. THE SHEATH, GUIDE WIRE AND BALLOON CATHETER WERE ALL REMOVED AS A SINGLE UNIT AND THE DETACHED PORTION OF THE BALLOON WAS CAUGHT IN THE SHEATH. NOTHING REMAINED IN THE PATIENT. A COMMENT WAS MADE THAT THE ARMADA 18 BALLOON DOESN'T SEEM TO RE-WRAP WELL. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9293032 ↗
• MalfunctionSep 7, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH MODERATE CALCIFICATION. A 4.0 X 200 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED TO THE LESION WITH NO RESISTANCE. THE BALLOON OF THE PTA BALLOON CATHETER RUPTURED ON THE FIRST INFLATION AT 14 ATMOSPHERES. AN ADDITIONAL UNSPECIFIED ARMADA PTA BALLOON CATHETER WAS USED TO SUCCESSFULLY DILATE THE LESION. 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 7856338 ↗