Armada 1013464-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648207785), received between Sep 13, 2018 and Aug 2, 2022 — 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 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.

• MalfunctionAug 2, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT THE LEFT SYSTOLIC AORTIC ARCH WITH HEAVY IN STENT STENOSIS. A 2.5X60MM ARMADA 18 BALLOON WAS INSERTED AND ADVANCED TO THE TARGET LESION WITHOUT ISSUES. HOWEVER, ON THE FIRST INFLATION, THE BALLOON RUPTURED AT 15 ATMOSPHERES. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH A NON-ABBOTT DEVICE. 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 15147657 ↗
• MalfunctionApr 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT ANTERIOR TIBIAL ARTERY THAT WAS MODERATELY CALCIFIED. REPORTEDLY, THE ARMADA 18 2.5MM/60MM/150CM OTW BALLOON RUPTURED AT 2 ATMOSPHERES DURING THE FIRST INFLATION. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AN UNSPECIFIED BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14252974 ↗
• MalfunctionSep 13, 2018Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED PROXIMAL ANTERIOR TIBIAL ARTERY. A 2.5 X 60 MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS USED; HOWEVER, THE TIP OF THE CATHETER BECAME KINKED DUE TO THE ANATOMY. THEREFORE, A NON-ABBOTT GUIDE WIRE COULD NOT ADVANCE THROUGH THE BDC DUE TO THE KINK. BOTH DEVICES WERE THEN REMOVED AS A SINGLE UNIT AS THE ARMADA BDC MET RESISTANCE WITH THE GUIDE WIRE. A CSI PROCEDURE WAS THEN PERFORMED WITH ANOTHER UNSPECIFIED BDC 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 7872758 ↗