Armada A1025-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648155734), received between May 1, 2024 and Jun 20, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Stretched; Difficult to Advance; Material Too Soft/Flexible; Stretched; Difficult to Advance; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT PERONEAL ARTERY BELOW THE KNEE WITH NO TORTUOSITY, MILD CALCIFICATION AND 65% STENOSIS. WHEN THE 2.5X40 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED OVER THE UNSPECIFIED .014 GUIDE WIRE, THE BALLOON SHAFT DID NOT HAVE AS MUCH SUPPORT AS USUAL. UPON REMOVAL FROM THE ANATOMY IT WAS FOUND THAT THE SHAFT WAS COMPLETELY COMPRESSED AND KINKED. ANOTHER ARMADA 14 DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE INNER AND OUTER MEMBER WERE STRETCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298595 ↗
• MalfunctionMay 1, 2024Deflation Problem; Difficult to Remove; Material Twisted/Bent; Deflation Problem; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO PERFORM RECANALIZATION AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE LOWER LEFT LEG USING THE ANTEGRADE APPROACH. THREE ARMADA BALLOON DILATATION CATHETERS (BDC) WERE ATTEMPTED TO BE USED IN THE PROCEDURE; HOWEVER, TWO OF THE ARMADA BALLOONS FAILED TO DEFLATE PROPERLY AND BOTH WERE DIFFICULT TO REMOVE. AFTER REMOVAL, THE BALLOONS WERE NOTED TO BE TWISTED. IN THE PHYSICIAN OPINION THE MATERIAL OF THE PTA BALLOONS IS WEAKER CAUSING BALLOON TWISTING [TORSION]. A THIRD ARMADA BDC WAS ATTEMPTED TO BE USED IN THE PROCEDURE; HOWEVER, THE BALLOON WAS NOTED TO HAVE A LEAK AT THE HUB. ANOTHER ARMADA 14 BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222987 ↗