Armada 1013464-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648207846), received between Mar 2, 2020 and Sep 18, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE TIBIAL ARTERY. A 2.5X120MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER DURING THE FIRST INFLATION ATTEMPT THE BALLOON WAS NOTED TO RUPTURE AT 10ATMS. THEREFORE THE BDC WAS REMOVED AND A NEW SAME SIZED ARMADA 18 BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23090956 ↗
• MalfunctionJun 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT POSTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION AND NO TORTUOSITY. THE 2.5X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND HAD NO RESISTANCE DURING ADVANCEMENT, HOWEVER, THE BALLOON RUPTURED AT 14 ATMOSPHERES (ATMS) ON THE FIRST INFLATION. THE BDC WAS REMOVED WITHOUT ISSUES. ANOTHER ARMADA 18 BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098709 ↗
• InjuryApr 4, 2022Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS FLUSHED WHILE INSIDE THE HOOP. THE 2.5MM X 200MM X 150CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. DURING THE SECOND INFLATION TO 18 ATMOSPHERES THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT RESISTANCE AND AFTER REMOVAL IT WAS OBSERVED THAT THE PROXIMAL BALLOON MARKER HAD DETACHED FROM THE BDC AND WAS LOCATED IN THE PERINEAL ARTERY. NO ATTEMPT WAS MADE TO RETRIEVE THE PROXIMAL BALLOON MARKER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14004057 ↗
• MalfunctionNov 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ANTERIOR TIBIAL ARTERY THAT WAS HEAVILY DISEASED. A 2.5X200MM ARMADA 18 WAS ADVANCED AND BURST WHEN INFLATED ONCE AT 8 ATMOSPHERES. ANOTHER UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10773383 ↗
• MalfunctionAug 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. TWO ARMADA 18 BALLOONS (2.5X200MM AND 3X200MM) WERE SEPARATELY ADVANCED TO THE LESION AND INFLATED ONCE AT 8 ATMOSPHERES AND RUPTURED. THE DEVICES WERE REMOVED AND CASE WAS ABORTED. 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 10376221 ↗
• MalfunctionMar 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED NON-TORTUOUS RIGHT ANTERIOR TIBIAL ARTERY. THE 2.5X200MM ARMADA 18 BALLOON RUPTURED ON THE FIRST INFLATION WHILE AT 8ATM. 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 Consequences Or Impact To Patient

  MAUDE report 9776091 ↗