Armada B2060-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648155291), received between Sep 2, 2016 and Jun 2, 2026 — classified as 4 injuries, 11 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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 6.0X100MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 10 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING ANOTHER ARMADA 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 25361255 ↗
• MalfunctionMar 23, 2026Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6.0 X 100 MM ARMADA 35 BALLOON DILATATION CATHETER, WHEN ASPIRATING THE BALLOON AIR WAS NOTED COMING INTO THE SYRINGE AND A HOLE WAS NOTED IN THE BALLOON. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662951 ↗
• MalfunctionFeb 10, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED ARTERIOVENOUS FISTULA WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. THE 6X100MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS ATTEMPTED TO BE INFLATED TO 5 ATMOSPHERES (ATM); HOWEVER, THE BALLOON DID NOT INFLATE AND A RUPTURED WAS SUSPECTED. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER SAME SIZE DEVICE WAS USED TO CONTINUE THE PROCEDURE. 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 21345624 ↗
• MalfunctionAug 31, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS LESION IN A SUPERFICIAL FEMORAL ARTERY (SFA). AN ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED FOR THE PROCEDURE; HOWEVER, UPON DEFLATING THE ARMADA 35 BDC AND WITHDRAWING THE AIR THROUGH AN UNSPECIFIED INFLATION DEVICE, AIR BUBBLES WERE NOTICED. IT WAS SUSPECTED THAT THERE WAS A HOLE IN THE BDC. THE BDC WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW BDC WAS USED WITHOUT ISSUE TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331818 ↗
• MalfunctionJun 8, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING DEVICE PREPARATION, THE ARMADA CATHETER (B2060-100, UNK LOT) WAS BEING PREPPED PER INSTRUCTIONS FOR USE WHEN THE CATHETER WOULD NOT HOLD PRESSURE AND WOULD PULL/LEAK AIR. THE OPERATOR SUSPECTED A HOLE SOMEWHERE ALONG THE DEVICE ALTHOUGH THE EXACT LOCATION WAS NOT KNOWN. THE DEVICE WAS DISCARDED AND NOT USED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS DEVICE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963122 ↗
• InjuryJul 23, 2020Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED FEMOROPOPLITEAL TRANSITION AREA THAT WAS 75% STENOSED. A 6.0X100MM ARMADA 35 CATHETER BALLOON WAS NOTED TO HAVE RUPTURED AT THE FIRST INFLATION AT 12 ATMOSPHERES. UPON REMOVAL RESISTANCE WAS MET WITH ANATOMY AND THE BALLOON COMPLETELY CAME OFF THE CATHETER. THE SEPARATED PORTION HAD TO BE RETRIEVED VIA SURGERY. NOTHING WAS LEFT IN THE ANATOMY AND PATIENT REMAINS IN THE HOSPITAL. THERE WAS NO PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10312124 ↗
• MalfunctionDec 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. THE 6.0 X 100 ARMADA 35 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION. THE BALLOON WAS INFLATED TO 16 ATMOSPHERES (ATM) AND A BALLOON RUPTURE OCCURRED. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT DIFFICULTY. THERE WAS NO ADVERSE PATIENT EFFECT. A SECOND ARMADA 35 DILATATION CATHETER WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492510 ↗
• InjuryJun 11, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION, HEAVILY CALCIFIED, MID SUPERFICIAL FEMORAL ARTERY. A 6.0X100MM ARMADA 35 BALLOON DILATION CATHETER (BDC) WAS INFLATED TO NOMINAL PRESSURE ONE TIME WITHOUT ISSUE. THERE WAS NO RESISTANCE FELT DURING WITHDRAWAL. THE PATIENT WAS DISCHARGED; HOWEVER, A FEW WEEKS AFTER THE PROCEDURE, THE PATIENT FELT PAIN IN THE LEG AND WAS RE-HOSPITALIZED FOR TREATMENT. THE PATIENT'S LEG WAS SURGICALLY OPENED AND IT WAS CONFIRMED THAT THE TIP AND BALLOON OF THE ARMADA 35 WERE STILL IN THE VESSEL. BOTH WERE SUCCESSFULLY REMOVED. AFTER THE INCIDENT, THE PATIENT FELT DELIRIUM AND WAS HOSPITALIZED IN A NURSING HOSPITAL FOR REST AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Pain

  MAUDE report 8689431 ↗
• InjuryApr 29, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE A 7 X 200 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED TO THE LESION WITH NO RESISTANCE; HOWEVER, THE BALLOON RUPTURED AND SEPARATED ON THE FIRST INFLATION. THE PRESSURE THAT THE BALLOON OF THE PTA BALLOON CATHETER RUPTURED AT IS NOT KNOWN AT THE INFLATION WAS PERFORMED WITH A 3CC SYRINGE AND NOT A PRESSURE MONITORED DEVICE. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE ALL THE SEPARATED PIECES OF THE BALLOON FROM THE PATIENT ANATOMY. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562667 ↗
• MalfunctionFeb 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) BUT THE BALLOON RUPTURED BELOW THE RATED BURST PRESSURE (RBP). ANOTHER, SAME SIZE 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 8303285 ↗
• InjuryFeb 1, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0X100MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. THE DEVICE WAS THEN INFLATED TWICE TO AN UNSPECIFIED PRESSURE. DURING THE THIRD INFLATION BELOW THE NOMINAL RATED BURST PRESSURE, THE BALLOON RIPPED/RUPTURED, AND THE DISTAL PORTION OF THE BALLOON WITH THE MARKER SEPARATED FROM THE PTA CATHETER. THE PROXIMAL PORTION OF THE PTA CATHETER WAS WITHDRAWN FROM THE PATIENT ANATOMY WITHOUT RESISTANCE, AND A SNARE WAS USED REMOVE THE SEPARATED BALLOON MATERIAL FROM THE PATIENT ANATOMY. IT WAS CONFIRMED THAT NO PIECES OF THE PTA CATHETER REMAINED IN THE PATIENT ANATOMY. THE PROCEDURE CONCLUDED AFTER THE PTA CATHETER WAS REMOVED AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS A REPORTED DELAY IN THE PROCEDURE TO SNARE THE SEPARATED BALLOON; HOWEVER, THE DELAY WAS NOT CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8298341 ↗
• MalfunctionDec 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 6.0X100 MM ARMADA 35 WAS ADVANCED TO THE MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY, BUT THE ARMADA RUPTURED WITH THE FIRST INFLATION AS THE INDEFLATOR WAS BETWEEN 4 TO 6 ATMOSPHERES OF PRESSURE. THE ARMADA STAYED IN ONE PIECE AND WAS REMOVED FROM THE ANATOMY. ANOTHER ARMADA 35 WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8185232 ↗
• MalfunctionMay 31, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE 6 X 100 ARMADA 35 BALLOON CATHETER WAS ADVANCED OVER THE GUIDE WIRE. PRIOR TO ENTERING THE PATIENT THE DEVICE WAS FLUSHED AT WHICH TIME THERE WAS A VISIBLE CRACK IN THE HUB NOTED EVIDENCED BY A LEAK. THE BALLOON CATHETER WAS REMOVED WITHOUT ISSUE AND A NEW ARMADA 35 BALLOON CATHETER WAS USED SUCCESSFULLY FOR TREATMENT. NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7557301 ↗
• MalfunctionDec 21, 2016Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO ECCENTRIC LESION IN THE COMMON ILIAC ARTERY WITH MILD TORTUOSITY AND MODERATE CALCIFICATION THAT WAS 90% STENOSED. RESISTANCE WAS NOT FELT DURING ADVANCEMENT OF THE 6.0 X 100 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) THROUGH THE LESION AND IT CROSSED SUCCESSFULLY FOR PRE-DILATATION. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES HELD FOR 10 SECONDS. A REPLACEMENT BDC WAS USED FOR PRE-DILATATION AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER A NON-ABBOTT STENT WAS IMPLANTED. 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 6194498 ↗
• MalfunctionSep 2, 2016Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY THAT WAS HEAVILY CALCIFIED. FOR PRE-DILATATION, AN ARMADA 35 BALLOON DILATATION CATHETER WAS USED, HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERES. A NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5925192 ↗