Armada A1030-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648155819), received between Jan 12, 2018 and Apr 10, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 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.

• MalfunctionApr 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY. THE 3X80 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER HAD A HOLE NOTED DURING INFLATION AND WAS REMOVED. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709436 ↗
• MalfunctionDec 26, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED TIBIAL ARTERY. THE COMMAND GUIDE WIRE WAS INSIDE OF AN ARMADA PERCUTANEUOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER AND TIP OF THE GUIDE WIRE BROKE OFF IN THE DISTAL TIBIAL VESSEL. THE TIP WAS RETRIEVED VIA SNARE. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED 12/08/2019 INDICATES THAT THE COMMAND GUIDE WIRE WAS ADVANCED WITHOUT RESISTANCE. THERE WAS DIFFICULTY DURING WITHDRAW OF THE ARMADA BALLOON AND THE GUIDE WIRE. SOME FORCE WAS REQUIRED AND BOTH THE GUIDE WIRE AND THE ARMADA BALLOON WERE REMOVED TOGETHER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9521887 ↗
• MalfunctionJan 12, 2018Inflation Problem

  IT WAS REPORTED THAT AN ARMADA DILATATION CATHETER WAS ADVANCED TO THE POSTERIOR TIBIAL, HEAVILY CALCIFIED LESION WITHOUT ISSUE. BALLOON INFLATION ATTEMPT WAS PERFORMED; HOWEVER, THE BALLOON FAILED TO INFLATE. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE AND ANOTHER DEVICE WAS USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7186540 ↗