Armada 1013469-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648208324), received between Dec 5, 2019 and Aug 4, 2025 — 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 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A SEVERELY STENOSED LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE 5.5X120MM ARMADA 18 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 14 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 22700185 ↗
• MalfunctionDec 16, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY / POPLITEAL ARTERY. THE 5.5 X 120 MM ARMADA 18 DILATATION CATHETER WAS PREPARED FOR USE AND NO ISSUES WERE NOTED. THE DEVICE WAS ADVANCED INTO THE PATIENT ANATOMY. THE DILATATION CATHETER BALLOON WAS INFLATED THREE TIMES. AFTER THE THIRD INFLATION TO 14 ATMOSPHERES, THE BALLOON RUPTURED. THE RUPTURE WAS LARGE AND THE BALLOON SEPARATED FROM THE DEVICE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND ALL SEPARATED PIECES WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13021246 ↗
• MalfunctionDec 5, 2019Deflation Problem; Difficult to Insert; Difficult to Remove; Deflation Problem; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT AFTER INFLATION OF THE ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER ONCE TO 8 ATMOSPHERES, THE BALLOON EXPERIENCED RESISTANCE AND COULD NOT BE PULLED BACK INTO THE SHEATH BECAUSE IT WAS NOT FULLY DEFLATED. NEGATIVE PRESSURE WAS HELD FOR 10 SECONDS. IT WAS ABLE TO BE REMOVED WITHOUT ISSUE; HOWEVER IT WAS UNABLE TO BE RE-INSERTED BACK INTO THE SHEATH. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9417748 ↗