Armada B1080-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648154850), received between Feb 14, 2017 and Jun 22, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. THE 8.0X20MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER WOULD NOT HOLD PRESSURE WHEN INFLATED DUE TO A HOLE IN THE BALLOON. 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 25579079 ↗
• MalfunctionNov 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS COMMON ILIAC ARTERY. THE 8.0X20MM ARMADA 35 BALLOON WAS UNABLE TO INFLATE IN THE ARTERY. IT WAS NOTED THE BALLOON WAS LOSING PRESSURE WHEN ATTEMPTING TO INFLATE. ANOTHER SAME SIZE ARMADA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 23512393 ↗
• MalfunctionAug 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT INTERNAL ILIAC ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. REPORTEDLY, AFTER A NON-ABBOTT STENT WAS DEPLOYED, THE ARMADA 35 BALLOON WAS USED FOR POST-DILATATION, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 12 ATMOSPHERES. A NON-ABBOTT BALLOON WAS USED TO CONTINUE 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 19953958 ↗
• InjuryJun 18, 2024Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENT GRAFT IN THE ARTERIOVENOUS (AV) FISTULA WITH HARD STENOSIS IN THE ANASTOMOSIS. THE 8X20 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED TWICE TO AN UNKNOWN PRESSURE AND RUPTURED. DURING REMOVAL THE DEVICE WAS STUCK AND THERE WAS RESISTANCE WITH A GUIDE WIRE AND EXTREME FORCE WAS USED TO REMOVE THE DEVICE. THE DISTAL PORTION OF THE BALLOON INCLUDING THE DISTAL MARKER SEPARATED AND WERE LEFT IN THE RIGHT ARM OF THE PATIENT. SURGERY WAS PERFORMED TO REMOVE THE SEPARATED PIECES AND MARKER FROM THE FISTULA AND NOTHING REMAINED IN THE PATIENT. IT IS BELIEVED PART OF THE BALLOON WAS BURNED UP BY THE DIATERMI [DIATHERMY]. THE ADDITIONAL PROCEDURE TOOK ABOUT 30 MINUTES EXTRA INCLUDING ANESTHETICS. THE PATIENT WENT HOME AFTER DIALYSIS NOT RELATED TO THIS PROCEDURE, AND WAS NOT HOSPITALIZED ADDITIONAL TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563727 ↗
• MalfunctionJul 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED MID SUPERFICIAL FEMORAL ARTERY IN THE LEFT LEG. A NON-ABBOTT STENT WAS IMPLANTED. DURING POST-DILATATION OF A 8X20MM ARMADA 35 BALLOON BURST AT 8 ATMOSPHERES. THEN A 5X40MM ARMADA 35 BALLOONS BURST AT 26 ATMOSPHERES. THE BALLOONS WERE AT THE PROXIMAL END OF THE STENT (2/3 OUTSIDE THE STENT AND TO 1/3 IN THE STENT) - WHEN IT BURST. THERE WAS NO DAMAGE TO THE PATIENT. THE BALLOONS WERE SUCCESSFULLY REMOVED. 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 14946704 ↗
• MalfunctionJan 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN IN-STENT RESTENOSIS IN THE EXTERNAL ILIAC ARTERY WITH MILD CALCIFICATION AND HEAVY TORTUOSITY. THE 8X20 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE TO THE LESION AND INFLATED ONCE TO 10 ATMOSPHERES (ATM) FOR 20 SECONDS AND RUPTURED. A NEW ARMADA 35 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13179953 ↗
• MalfunctionNov 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS, 80% STENOSED LEFT ILIAC ARTERY. AN 8X20MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. AN UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY 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 12729068 ↗
• InjuryDec 5, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A FISTULA. DURING USE, THE ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED AND SEPARATED. THE SEPARATED PIECES WERE RETRIEVED WITH A SNARE AND THE PROCEDURE CONTINUED. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9417710 ↗
• MalfunctionSep 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS SHUNT GRAFT. THE 8X20 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS AIR ASPIRATED OUTSIDE THE ANATOMY PRIOR TO USE. THE CATHETER WAS INFLATED TWICE TO 15 ATMOSPHERES (ATM) AND RUPTURED. ANOTHER, SAME SIZE, ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 9014478 ↗
• MalfunctionFeb 14, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO CONCENTRIC LESION IN THE ILIAC WITH NO TORTUOSITY AND MILD CALCIFICATION THAT WAS 90% STENOSED. RESISTANCE WAS NOT FELT DURING ADVANCEMENT OF AN 8.0 MM X 20 MM/80 CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) TO THE LESION AND IT CROSSED SUCCESSFULLY; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES, HELD FOR 30 SECONDS. THE DEVICE WAS REPLACED WITH A NON-ABBOTT BDC TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6330815 ↗