Armada A1025-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648155772), received between Jun 26, 2020 and May 1, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 1, 2024Leak/Splash; Leak/Splash

  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 19222994 ↗
• MalfunctionNov 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE AN PERONEAL ARTERY WITH HEAVY CALCIFICATION. THE 2.5X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON PRESSURE BEGAN DROPPING FASTER THAN ANTICIPATED. A LEAK AT THE HUB OF THE BDC WAS NOTED. 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 18124582 ↗
• MalfunctionJun 26, 2020Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MODERATELY CALCIFIED, NON-TORTUOUS, 90% STENOSED POSTERIOR TIBIAL ARTERY. A 2.5X200MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED, AND THE BALLOON WAS ATTEMPTED TO BE INFLATED TO RATED BURST PRESSURE; HOWEVER, THE BALLOON COMPLETELY FAILED TO INFLATE DESPITE SEVERAL ATTEMPTS. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED A PINHOLE RUPTURE ON THE BALLOON, WHICH LEAKED FLUID DURING TESTING. AFTER FOLLOW-UP, IT WAS REPORTED THAT THE LEAK IN THE BALLOON WAS NOTICED BY THE PHYSICIAN SINCE THE BALLOON FAILED TO INFLATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10203343 ↗