Armada B1120-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648154973), received between Sep 6, 2017 and Jun 10, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE COMMON ILIAC ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 100% STENOSIS. THE 12X20 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES AND RUPTURED. ANOTHER ARMADA WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460259 ↗
• MalfunctionMay 2, 2025Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS ILIAC ARTERY. ONCE AT THE LESION, THE 12X20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 12 ATMOSPHERES DURING THE SECOND INFLATION. THE ARMADA 35 BDC WAS REMOVED AND A NON-ABBOTT BALLOON AND UNSPECIFIED DRUG-COATED BALLOON WERE 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 21952113 ↗
• MalfunctionApr 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS ILIAC ARTERY. AN UNSPECIFIED GUIDEWIRE CROSSED THE LESION. A 12X20MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED AND ONCE AT THE LESION, THE BALLOON RUPTURED ON THE SECOND INFLATION AT 10 ATMOSPHERES. THE ARMADA 35 BDC WAS REMOVED AND A NON-ABBOTT BALLOON AND UNSPECIFIED DRUG-COATED BALLOON WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 21868372 ↗
• MalfunctionNov 2, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING ATTEMPTED AIR ASPIRATION OF THE 12X20MM ARMADA 35, PRIOR TO USE IN THE PATIENT, NEGATIVE PRESSURE COULD NOT BE APPLIED AND THE DEVICE CONTINUED ASPIRATING. THEREFORE, THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A DIFFERENT SIZED ARMADA WAS USED FOR THE PROCEDURE. 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 18062230 ↗
• MalfunctionSep 22, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE LEFT PULMONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 12.0X20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, RUPTURED AFTER 10 SECONDS AT 8 ATMOSPHERES DURING THE FIRST INFLATION. THE BDC WAS REMOVED FROM THE PATIENT AND ANOTHER ARMADA BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17799540 ↗
• MalfunctionDec 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TREATING A RIGHT SUBCLAVIAN, 80% STENOSED LESION WITHIN A DIALYSIS CIRCUIT. DURING USE, THE ARMADA BALLOON RUPTURED. A NON-ABBOTT DEVICE WAS USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8185059 ↗
• MalfunctionSep 6, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSIS IN A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) AND A 90% STENOSIS IN A HEAVILY CALCIFIED COMMON ILIAC ARTERY. A 6 X 80 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS SELECTED FOR PRE-DILATATION OF THE LESION IN THE SFA. THE PTA CATHETER WAS ADVANCED TO THE LESION AND WHEN INFLATED TO 10 ATMOSPHERES (ATM) THE BALLOON RUPTURED. A NEW 7 X 80 MM ARMADA 35 PTA CATHETER WAS USED TO COMPLETE THE PRE-DILATATION AND AN UNSPECIFIED STENT IMPLANT WAS SUCCESSFULLY DEPLOYED. FOLLOWING DEPLOYMENT OF AN UNSPECIFIED STENT IMPLANT IN THE COMMON ILIAC ARTERY, A 10 X 20 MM ARMADA 35 PTA CATHETER WAS SELECTED FOR POST- DILATATION. WHEN INFLATED TO 13 ATM THE BALLOON RUPTURED AND WAS REPLACED WITH A 12 X 20 MM ARMADA 35 PTA CATHETER. WHEN INFLATED TO 10 ATM THE BALLOON RUPTURED. AS THERE WAS SUFFICIENT WALL APPOSITION ADDITIONAL POST-DILATATION WAS NOT NECESSARY. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6846306 ↗