Armada B1080-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648154874), received between Sep 15, 2016 and Jun 2, 2025 — classified as 1 death, 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN AV FISTULA IN THE CEPHALIC VEIN. THE 8.0X60MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED, WITHOUT RESISTANCE TO THE TARGET LESION. THE BDC WAS INFLATED 3 TIMES TO 4 ATMOSPHERES (ATM) FOR EACH INFLATION. ON THE 3RD INFLATION TO 4 ATM, THE BALLOON RUPTURED. THE BDC WAS REMOVED IN ONE PIECE WITH NOTHING LEFT IN THE ANATOMY AND NO RESISTANCE DURING THE REMOVAL. A NON-ABBOTT NON-COMPLIANT BALLOON WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125586 ↗
• MalfunctionDec 12, 2024Difficult to Remove; Material Rupture; Material Too Soft/Flexible; Material Split, Cut or Torn; Difficult to Remove; Material Rupture; Material Too Soft/Flexible; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED EXTERNAL ILIAC ARTERY. SURGICAL CUTDOWN WAS PERFORMED TO OBTAIN ACCESS TO THE EXTERNAL ILIA ARTERY. THE 8.0X60MM ARMADA 35 BALLOON WAS INFLATED AND AFTER DEFLATION OF THE DEVICE A RUPTURE WAS NOTED. BLOOD WAS OBSERVED IN THE SYRINGE; THEREFORE, THE ARMADA 35 BALLOON WAS ATTEMPTED TO BE REMOVED BUT RESISTANCE WAS FELT AND THE BALLOON TEARED LONGITUDINALLY. THERE WAS DIFFICULTY IN PULLING BACK THE ARMADA INTO INTRODUCER SHEATH THEREFORE, THE ENTIRE SYSTEM WAS REMOVED ALTOGETHER. IT WAS NOTED THAT THE BALLOON SEEMED MORE SOFT THAN USUAL (NOT ENOUGH SUPPORT). 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 20920380 ↗
• InjuryDec 6, 2024Material Rupture; Material Separation; Material Rupture; Material Separation

  USER FACILITY MEDWATCH REPORT (MW5161097) RECEIVED THAT STATES: DOCTOR WAS INFLATING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. AT THIS TIME, THE PTA CATHETER WAS ALREADY INSERTED IN THE PATIENT'S LEFT ARM. AS HE INFLATED THE BALLOON UNDER FLUOROSCOPY, HE IMMEDIATELY RECOGNIZED THAT THE BALLOON BURST, AND THE DISTAL END OF THE CATHETER WAS BROKEN OFF. HE REMOVED THE CATHETER THAT WAS STILL INTACT AND USED FLUOROSCOPY TO GUIDE HIM IN THE REMOVAL OF THE DETACHED BALLOON. ALL CONTENTS OF THE CATHETER WERE QUICKLY REMOVED FROM INSIDE THE PATIENT AND WAS CONFIRMED WITH FLUOROSCOPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20868641 ↗
• MalfunctionJan 16, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 8X60MM ARMADA 35 BALLOON CATHETER, THE HUB WAS NOTED TO BE CRACKED/BROKEN. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER ARMADA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED A LEAK OF FLUID OUT OF THE CRACKS IN THE HUB ON FUNCTIONAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518704 ↗
• MalfunctionNov 17, 2023Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ARTERIO-VENOUS FISTULA. THE BALLOON OF AN 8X60MM ARMADA 35 CATHETER WAS UNABLE TO INFLATE AND A LEAK WAS OBSERVED FROM A CRACK AT THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER ARMADA 35 CATHETER. 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 18160766 ↗
• InjuryOct 30, 2023Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEPATIC TRUNK ARTERY. THE 8X60MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER MET RESISTANCE DURING ADVANCEMENT DUE TO THE LESION; HOWEVER, WAS INFLATED TWICE UP TO 12 ATMOSPHERES AND A RUPTURE OCCURRED. DURING REMOVAL THE DEVICE SEPARATED INTO TWO PIECES AND A FRAGMENT BECAME STUCK ON THE WIRE; THEREFORE, A LOOP SNARED WAS USED TO RETRIEVE THE SEPARATED BALLOON FRAGMENT. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030707 ↗
• MalfunctionJul 20, 2023Off-Label Use; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Off-Label Use; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT CEPHALIC ARCH VEIN WITH MILD TORTUOSITY. THE 8/60MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION AND INFLATED ONCE, BUT THE BALLOON RUPTURED WHEN INFLATED TO 23 ATMOSPHERES. THE BALLOON SEPARATED AND ONE PART REMAINED ON THE BALLOON CATHETER AND THE OTHER PART WAS ON THE GUIDE WIRE. NOTHING WAS LEFT IN THE ANATOMY. AFTER THE ARMADA WAS REMOVED, THE PROXIMAL MARKER WAS NOTED TO BE MISSING BUT WAS FOUND ON THE TABLE. ANOTHER ARMADA 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 17362520 ↗
• InjuryFeb 2, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE 8.00X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPPED PER INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT AV FISTULA. THE BDC WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED 2 TIMES TO 18 ATMOSPHERES (ATM); HOWEVER, DURING THE SECOND INFLATION THE BALLOON RUPTURED TRANSVERSELY. THE BDC WAS REMOVED FROM THE PATIENT, WITH FRAGMENTS OF THE BALLOON REMAINING IN THE PATIENT. ANOTHER BDC WAS ADVANCED PAST THE BALLOON FRAGMENTS. THE BALLOON WAS THEN INFLATED TRAPPING THE FRAGMENTS SO THAT THE FRAGMENTS COULD BE SNARED OUT OF THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16288022 ↗
• MalfunctionDec 1, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT INTERNAL ILIAC ARTERY. AN 8X60MM ARMADA 35 BALLOON WAS INFLATED ONCE AND RUPTURED AT 4 ATMOSPHERES. A NON-ABBOTT BALLOON 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 15898581 ↗
• MalfunctionOct 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY STENOSED LESION IN THE CEPHALIC VEIN. AN 8X60MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION AND RUPTURED ON THE FIRST INFLATION AT 11 ATMOSPHERES. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AN 8X40X80 ARMADA BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656718 ↗
• MalfunctionFeb 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A RIGHT CORONARY ARTERY INTERVENTION, THE ARMADA BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 12 ATMOSPHERES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518862 ↗
• MalfunctionFeb 9, 2022Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  B5 CORRECTION: IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 60% STENOSED VESSEL INVOLVING AN ARTERIOVENOUS (AV) DIALYSIS FISTULA IN THE LEFT ARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13500178 ↗
• MalfunctionSep 30, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY CALCIFIED, 50% STENOSED ILIAC ARTERY. AN 8X60MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED. THE BALLOON PARTIALLY INFLATED, AND AN UNKNOWN LEAK WAS NOTED. 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 12558255 ↗
• DeathJul 29, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE EXTERNAL ILIAC ARTERY. THE 8.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS SELECTED EVEN THOUGH THE BALLOON WAS OVERSIZED FOR THE VESSEL. THE BALLOON WAS INFLATED AND THE VESSEL PERFORATED. THE PATIENT WENT INTO CARDIAC ARREST AND RESUSCITATION WAS ATTEMPTED HOWEVER WAS UNSUCCESSFUL AND THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Perforation of Vessels

  MAUDE report 12246693 ↗
• MalfunctionJul 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT FOREARM FISTULA. AN 8X60MM ARMADA 35 BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE AND ADVANCED WITHOUT RESISTANCE. ONCE AT THE TARGET LESION, THE BALLOON WAS BEING INFLATED BELOW NOMINAL FOR THE FIRST TIME; HOWEVER, A LEAK OF CONTRAST WAS NOTED ON ANGIOGRAM IN THE BALLOON AREA. THE BALLOON CATHETER WAS REMOVED AND A PINHOLE ON THE BALLOON WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 8X60MM ARMADA 35 BALLOON CATHETER. 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 12222209 ↗
• InjuryJun 7, 2021Off-Label Use; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Off-Label Use; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RE-STENOSED LESION LOCATED IN THE RIGHT ILIAC VEIN THAT WAS NON-CALCIFIED AND NON-TORTUOUS. AFTER THE ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION, AND DURING THE SECOND INFLATION BELOW NOMINAL PRESSURE, THE ARMADA BALLOON RUPTURED CIRCUMFERENTIALLY. DURING REMOVAL OF THE DEVICE, THERE WAS RESISTANCE AND DEVICE INTERACTION WITHIN THE STENT; THE BALLOON FOLDED OVER ON ITSELF AND THE DISTAL PART OF THE BALLOON SEPARATED IN THE PATIENT. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE SEPARATED BALLOON PORTION. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11947493 ↗
• MalfunctionDec 17, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THIS PROCEDURE WAS PERFORMED TO TREAT A HIGH GRADE STENOSED AND MILDLY TORTUOUS LEFT AV FISTULA. AN ARMADA 35 BALLOON CATHETER WAS INSERTED INTO THE STENOTIC AREA AND ANGIOPLASTY WAS PERFORMED. THE BALLOON WAS SUCCESSFULLY INFLATED TO 17ATM AND WAS ABLE TO RESOLVE MOST OF THE STENOTIC AREA. HOWEVER, AFTER THE BALLOON WAS FULLY DEFLATED, IT WAS NOTED THAT DUE TO PATIENT ANATOMY, RESISTANCE WAS FELT DURING REMOVAL. THE BALLOON CATHETER WAS ABLE TO BE REMOVED WITHOUT CAUSING ANY ADVERSE PATIENT¿S EFFECTS. A NON-ABBOTT DEVICE WAS THEN USED TO TREAT THE REST OF THE STENOTIC AREA. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11031949 ↗
• MalfunctionFeb 21, 2018Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED RIGHT COMMON ILIAC. THE 8MM X 60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE FOR PRE-DILATATION. AFTER PRE-DILATION WAS PERFORMED DURING REMOVAL, RESISTANCE WAS FELT WITH THE INTRODUCER SHEATH. THE BDC AND INTRODUCER SHEATH WERE REMOVED AS A SINGLE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7286795 ↗
• InjuryJan 12, 2018Detachment Of Device Component; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION LOCATED IN THE CEPHALIC VEIN. DURING REMOVAL, THE BALLOON BROKE AND HAD TO BE RETRIEVED. THE BALLOON WAS NOT FULLY DEFLATED AND WHEN REMOVING FROM THE SHEATH, IT SEPARATED. THERE WAS NO REPORTED DEFLATION ISSUE, THE PHYSICIAN DID NOT MAKE SURE IT WAS FULLY DEFLATED BEFORE TRYING TO REMOVE. A SNARE DEVICE WAS USED TO REMOVE THE SEPARATED SEGMENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. RESISTANCE WAS NOTED DURING WITHDRAWAL WITH THE INTRODUCER SHEATH. DEVICE ANALYSIS REVEALED THE BALLOON WAS SEPARATED RADIALLY, ALSO, THE INNER MEMBER WAS SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7187877 ↗
• MalfunctionFeb 8, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS, DISTAL COMMON ILIAC ARTERY. THE 8 MM/60 MM ARMADA 35 BALLOON RUPTURED UPON THE FIRST INFLATION TO 14 ATMOSPHERES. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THE BALLOON CATHETER TO THE LESION. A NEW BALLOON CATHETER WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6312157 ↗
• MalfunctionSep 15, 2016Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY STENOSED VENUS AV FISTULA OF THE ARM. AN 8 X 60 MM ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE AND INFLATED TO 14 ATMOSPHERES; HOWEVER, THE BALLOON WOULD NOT INFLATE FULLY. THERE WAS A WAIST IN THE BALLOON. A NON-ABBOTT 7 X 40 MM BALLOON CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5954079 ↗