Armada A2015-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648155901), received between Mar 17, 2022 and May 20, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 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.

• MalfunctionMay 20, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR TIBIAL ARTERY. DURING PRE-DILATATION, THE 1.5X20X150CM ARMADA 14 BALLOON WAS ADVANCED BUT THERE WAS NOTED RESISTANCE DURING ADVANCEMENT DUE TO CALCIUM, HOWEVER IT REACHED THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES (ATM). A 1.5X120X150CM ARMADA 14 BALLOON WAS THEN USED BUT THERE WAS NOTED RESISTANCE DURING ADVANCEMENT DUE TO CALCIUM, HOWEVER IT REACHED THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 5ATM. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353472 ↗
• MalfunctionMay 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2022, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE PERONEAL ARTERY LESION. AN ARMADA BALLOON CATHETER ADVANCED WITHOUT ISSUE. ON THE INITIAL INFLATION ATTEMPT, THE BALLOON RUPTURED AT 12 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ISSUES. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283402 ↗
• MalfunctionMar 17, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED DURING PREPARATION OF AN ARMADA 14 1.5MM/20MM/150CM BALLOON DILATATION CATHETER (BDC), THE PHYSICIAN REMOVED THE PROTECTIVE COVER AND NOTICED THE BALLOON WAS BROKEN. THEREFORE, THE DEVICE WAS NOT USED AND WAS REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A LONGITUDINAL TEAR IN BOTH SIDES OF THE BALLOON 5.5MM PROXIMAL TO THE PROXIMAL END OF THE DISTAL BALLOON MARKER FOR A LENGTH OF 8MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13794903 ↗