Armada 1013466-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648207952), received between Oct 23, 2019 and Apr 27, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. A 4.00X40MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED AFTER THE SECOND INFLATION AT NOMINAL PRESSURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. ANOTHER ARMADA BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14224093 ↗
• MalfunctionApr 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE TIBIOPERONEAL TRUNK. THE 4.0MM X 40MM X 150CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. DURING THE FIRST INFLATION, TO 6 ATMOSPHERES, THE BALLOON RUPTURED. A SAME SIZE ARMADA 18 WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14000750 ↗
• MalfunctionMay 20, 2021Failure to Fold; Failure to Fold

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT AV FISTULA. DURING RE-INSERTION INTO THE SHEATH, THE RE-WRAP OF THE 4.0X40MM ARMADA 18 BALLOON WAS LOOSE, AND RE-INSERTION INTO THE SHEATH WAS DIFFICULT. EVENTUALLY THE BALLOON WAS ABLE TO BE RE-INTRODUCED INTO THE SHEATH. 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 11860596 ↗
• MalfunctionOct 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2019, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE SUPERFICIAL FEMORAL ARTERY (SFA), HEAVILY CALCIFIED LESION. UPON THE FIRST INFLATION TO 13 ATMOSPHERES, THE ARMADA DILATATION CATHETER BALLOON BURST. REPORTEDLY, THE PATIENT IS IN FINE CONDITION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9227124 ↗