Armada B1040-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648154508), received between Jul 6, 2020 and Mar 31, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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.

• MalfunctionMar 31, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE EXTERNAL ILIAC ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 4X20MM ARMADA 35 BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 16 ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED, AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744343 ↗
• MalfunctionJan 14, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS, STENOSED ILIAC LESION. DURING ADVANCEMENT OF THE 4.0X20MM ARMADA BALLOON DILATATION CATHETER (BDC), DIFFICULTY WAS NOTED DUE TO ANATOMY AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT THE RATED BURST PRESSURE. A NON-ABBOTT BALLOON AND DRUG-COATED BALLOON WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073167 ↗
• MalfunctionDec 2, 2020Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING PREPARATION A 4.0X20MM ARMADA 35 PTA CATHETER WAS ATTEMPTED TO BE INFLATED; HOWEVER FAILED. THE BALLOON WAS NOTED TO HAVE A TEAR. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. CORRECTION: THE REPORTED LEAK WAS NOTED DURING PREPARATION WHEN PERFORMING AIR ASPIRATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10935375 ↗
• MalfunctionJul 6, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE HEAVILY TORTUOUS, CONCENTRIC LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 4.0X20 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITH NOTED RESISTANCE WITH THE CALCIFIED LESION. THE ARMADA 35 BALLOON WAS INFLATED TO NOMINAL PRESSURE AND RUPTURED. A NEW ARMADA PTA CATHETER 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 Consequences Or Impact To Patient

  MAUDE report 10235541 ↗