Armada B1060-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 08717648154690), received between Jan 12, 2017 and Jun 11, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (51 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 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), A BALLOON LEAK WAS NOTED WHEN ATTEMPTING TO PULL NEGATIVE. THE BDC WAS NOT USED IN THE PROCEDURE. ANOTHER ARMADA BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25480709 ↗
• MalfunctionMay 28, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE AV FISTULA. THE 6X40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, AT THE THIRD INFLATION IT WAS NOTED THAT THE BALLOON HAD RUPTURE AT 20 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT, AND THE BALLOON WAS NOTED TO BE LEAKING. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322322 ↗
• MalfunctionApr 9, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, HEAVILY TORTUOUS AV FISTULA LESION WITH 90% STENOSIS. A 6X40 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE AS PER THE INSTRUCTIONS FOR USE WITHOUT ISSUE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION WITHOUT RESISTANCE; HOWEVER, THE DEVICE COULD NOT BE PRESSURIZED TO 20 ATMOSPHERES AND A LEAK WAS NOTED IN THE PROXIMAL SHAFT. AN ADDITIONAL 6X40 MM BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24837578 ↗
• MalfunctionApr 6, 2026Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE EXTERNAL ILIAC ARTERY. THE 6X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS FOUND TO BE LEAKING AT THE HUB DURING USE. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794015 ↗
• MalfunctionMar 20, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, HEAVILY TORTUOUS ARTERIOVENOUS FISTULA THAT WAS 90% STENOSED. THE 6 X 40 MM ARMADA BALLOON DILATATION CATHETER WAS ADVANCED AND RESISTANCE WAS NOTED WITH THE ANATOMY. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERES. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650765 ↗
• MalfunctionMar 18, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ARTERIOVENOUS FISTULA WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 6 X 40 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION AND INFLATED TO 20 ATMOSPHERES ON THE FIRST INFLATION. UPON THE SECOND INFLATION TO 16 ATMOSPHERES, THE BALLOON RUPTURED. ANOTHER SAME SIZE ARMADA PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628205 ↗
• MalfunctionFeb 17, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LOWER EXTREMITY LESION. THE 6X40MM ARMADA 35 PTA BALLOON DILATION CATHETER (BDC) WAS PREPARED FOR USE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE. THE METHOD USED TO COMPLETE THE PROCEDURE WAS NOT PROVIDED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368243 ↗
• MalfunctionJan 13, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS FISTULA STENOSIS. REPORTEDLY, THE 6.0X40 MM ARMADA BALLOON WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE, WITHOUT ANY ISSUES. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THIS BALLOON. IT WAS INFLATED TO 20 ATMOSPHERES [RATED BURST PRESSURE] OF PRESSURE WITH THE FIRST INFLATION. WHEN IT WAS INFLATED TO 15 ATMS DURING THE SECOND INFLATION, THE ARMADA RUPTURED. THE PHYSICIAN REPLACED IT WITH ANOTHER SAME SIZE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24057087 ↗
• MalfunctionDec 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT ARTERIOVENOUS FISTULA STENOSIS UNDER COLOR DOPPLER ULTRASOUND GUIDANCE IN THE HEMODIALYSIS CATHETERIZATION ROOM. THE 6X40 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION AND INFLATED TO 16 ATMOSPHERES FOR 1 MINUTE. DURING THE SECOND INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A NON-ABBOTT BALLOON 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 23907756 ↗
• MalfunctionDec 16, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ARTERIOVENOUS FISTULA (AVF) WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 70% STENOSIS. THE 6X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS USED BUT THE CONNECTION BETWEEN THE BALLOON TIP AND THE BALLOON PUMP WAS NOT SEALED. A LEAK OF AIR OCCURRED AT THE CONNECTION BETWEEN THE ARMADA AND THE INFLATION DEVICE, PRIOR TO INFLATION. ANOTHER SAME SIZE ARMADA 35 PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824853 ↗
• MalfunctionDec 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE SUBCLAVIAN ARTERY. THE 6.0X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER DURING INFLATION TO NOMINAL PRESSURE, IT WAS NOTED AIR WAS FLOWING BACK IN THE INDEFLATOR, THE PHYSICIAN SUSPECTED A LEAK. THE DEVICE WAS REMOVED AND ANOTHER SAME SIZE ARMADA 35 WAS USED HOWEVER THE SAME ISSUE OCCURRED. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED USING A THIRD ARMADA 35. 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 23816110 ↗
• MalfunctionDec 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE SUBCLAVIAN ARTERY. THE 6.0X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER DURING INFLATION TO NOMINAL PRESSURE, IT WAS NOTED AIR WAS FLOWING BACK IN THE INDEFLATOR, THE PHYSICIAN SUSPECTED A LEAK. THE DEVICE WAS REMOVED AND ANOTHER SAME SIZE ARMADA 35 WAS USED HOWEVER THE SAME ISSUE OCCURRED. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED USING A THIRD ARMADA 35. 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 23816085 ↗
• MalfunctionDec 11, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS ILIAC ARTERY. DURING ADVANCEMENT OF THE 6.0X40MM ARMADA 35 BALLOON DILATATION CATHETER, DUE TO THE TIGHT LESION, RESISTANCE/DIFFICULTY WAS NOTED AND THE ARMADA 35 BALLOON RUPTURED AT 20 ATMOSPHERES DURING THE FIRST INFLATION. AN UNSPECIFIED BALLOON AND 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 23783257 ↗
• MalfunctionDec 10, 2025Material Rupture; Material Rupture

  THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS FISTULA STENOSIS IN THE CEPHALIC VEIN. ONCE AT THE FISTULA, THE 6.0X40MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED AT 18 ATMOSPHERES DURING THE SECOND INFLATION. A NON-ABBOTT BALLOON 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 23773938 ↗
• MalfunctionOct 15, 2025Material Rupture; Material Rupture

  SUBSEQUENTLY AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, DEVICE ANALYSIS INDICATES THAT THERE WAS NO DEVICE MALFUNCTION AS THE BALLOON CATHETER WAS INFLATED AND MAINTAINED PRESSURE. NO BALLOON RUPTURE WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293650 ↗
• MalfunctionOct 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS SUBCLAVIAN ARTERY. THE 6.0X40MM ARMADA 35 BALLOON CATHETER WAS INFLATED ONCE AND WHEN ATTEMPTING TO INFLATE A SECOND TIME, AIR WAS OBSERVED FLOWING BACK TOWARDS THE INFLATOR DEVICE. 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 23203110 ↗
• MalfunctionAug 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE ATRIOVENTRICULAR FISTULA. A 6.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES. THE BDC WAS INFLATED ONCE TO 20ATMS, THEN INFLATED ONCE MORE TO 13ATMS HOWEVER DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE. THEREFORE THE BDC WAS REMOVED AND ANOTHER SAME SIZED ARMADA 35 BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897123 ↗
• MalfunctionJun 9, 2025Leak/Splash; Leak/Splash

  SUBSEQUENTLY AFTER THE INITIAL REPORT WAS FILED, IT WAS CONFIRMED THAT A 6.0 X 40 MM ARMADA 35 BALLOON DILATATION CATHETER WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168828 ↗
• MalfunctionApr 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN AN ARTERIOVENOUS FISTULA WITH STENOSIS. A 6X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER, DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 18ATMS. THEREFORE, THE BDC WAS REMOVED AND A NEW SAME SIZED ARMADA 35 BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS, NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21827899 ↗
• MalfunctionFeb 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING THE PROCEDURAL PREPARATION OF A 6X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) THAT AIR BUBBLES WERE NOTED TO BE INTRODUCED INTO THE SYRINGE, WHEN NEGATIVE PRESSURE WAS BEING APPLIED. THE SYRINGE AND STOP COCK WERE REPLACED AND ALL CONNECTIONS WERE CHECKED BUT THE ISSUE PERSISTED. THEREFORE, THE BDC WAS REPLACED WITH A NEW ARMADA BDC AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349690 ↗
• MalfunctionFeb 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE CEPHALIC VEIN. A 6X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INTO THE ANATOMY AND ATTEMPTED TO BE USED FOR VESSEL DILATATION; HOWEVER, THE BALLOON WAS NOTED TO RUPTURE DURING THE FIRST INFLATION AT 18 BAR. THE BDC WAS REPLACED WITH A NON-ABBOTT DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337603 ↗
• MalfunctionNov 13, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION IN A ATRIOVENTRICULAR FISTULA WITH THE 6X40MM ARMADA 35 BALLOON PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER. THE BALLOON WAS INFLATED ONCE TO 12 ATMOSPHERES (ATM) WHEN A RUPTURE OCCURRED AND AIR LEAKED. ANOTHER SAME SIZE ARMADA PTA WAS USED TO CONTINUE 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 20676163 ↗
• MalfunctionAug 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE AV FISTULA. THE 6X40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, THE BALLOON RUPTURED BELOW RATED BURST PRESSURE (RBP). THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20103071 ↗
• MalfunctionJul 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN AV FISTULA ARTERY. THE 6.0X40MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED BELOW RATED BURST PRESSURE DURING THE FIRST INFLATION. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19783743 ↗
• MalfunctionJul 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN AV FISTULA. THE 6.0X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET VESSEL AND PRESSURIZED HOWEVER THE BALLOON RUPTURED BELOW THE RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. 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 19749275 ↗