Armada B2050-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648155192), received between Jan 25, 2017 and May 29, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (4 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.

• MalfunctionMay 29, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION OF THE 5.0X80MM ARMADA 35 BALLOON DILATATION CATHETER, A HOLE WAS FOUND ON THE BALLOON. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR 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 25334222 ↗
• MalfunctionAug 7, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT SUPERFICIAL FEMORAL ARTERY WITH MODERATE TORTUOSITY, MODERATE CALCIFICATION AND 80% STENOSIS. THE 5.0X80MM ARMADA 35 BALLOON DILATATION CATHETER WAS PREPPED PER IFU AND ADVANCED OVER AN UNSPECIFIED 0.035 GUIDE WIRE. THE BALLOON WAS PARTIALLY INFLATED WHEN A LEAK WAS NOTED AT THE HUB THUS PREVENTING THE BALLOON FROM FULLY EXPANDING. A 5X100MM ARMADA 35 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 19928855 ↗
• MalfunctionJan 25, 2024Break; Leak/Splash; Break; Leak/Splash

  SUBSEQUENT TO THE INITIAL MDR REPORT, ADDITIONAL INFORMATION WAS RECEIVED. THE INDEFLATOR USED DURING THIS PROCEDURE WAS A NON-ABBOTT DEVICE. THERE WAS NO RESISTANCE NOTED WHEN CONNECTING THE LUER TO THE INDEFLATOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580250 ↗
• MalfunctionJan 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 5.00X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION FOR PRE-DILATATION. DURING THE FIRST INFLATION TO 8 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THE BDC WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A 5.00X100MM ARMADA BALLOON WAS USED CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274850 ↗
• MalfunctionJun 2, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AIR PREPARATION OF THE 5X80 MM ARMADA 35 BALLOON PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, PER INFORMATION FOR USE, WHEN PULLING NEGATIVE, AIR WAS NOTED IN THE INFLATION DEVICE, SUGGESTING A HOLE IN THE BALLOON. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NEW, SAME SIZE ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580689 ↗
• InjuryMay 17, 2022Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HIGH-GRADE STENOSIS OF THE PELVIC AXIS WITH MODERATELY CALCIFIED VESSELS IN THE COMMON AND EXTERNAL ILIAC ARTERIES FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. AN ARMADA BALLOON WAS ADVANCED TO THE LESION WITHOUT ISSUE AND INFLATED FOR ABOUT 2 MINUTES, UP TO A PRESSURE OF ABOUT 16 ATMOSPHERES WITH MODERATE IMPROVEMENT BUT THEN A LOCAL DISSECTION WAS NOTED DUE TO THE ARMADA BALLOON. A NON-ABBOTT SELF-EXPANDING STENT (7 X 80 MM) WAS IMPLANTED WITHOUT ANY PROBLEMS TO TREAT THE DISSECTION. USING THE SAME ARMADA 35 BALLOON TO PERFORM STANDARD POST DILATATION, THE BALLOON WAS INFLATED BUT A RUPTURE OCCURRED AT 12 ATMOSPHERES. SUBSEQUENTLY, THE BALLOON COULD NOT BE PULLED BACK INTO THE INTRODUCER SHEATH AS RESISTANCE WAS MET. AFTER WITHDRAWING THE BALLOON TOGETHER WITH THE SHEATH UP INTO THE LEFT ARM (A. BRACHIALIS), IT STILL COULD NOT BE REMOVED. THE PATIENT EXPERIENCED LOCAL PAIN AND A CLEAR RESISTANCE WAS NOTICED WHEN PULLING ON THE BALLOON CATHETER. SURGERY WAS PERFORMED TO SUCCESSFULLY REMOVE THE BALLOON AND SHEATH TOGETHER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Vascular Dissection

  MAUDE report 14415705 ↗
• MalfunctionAug 1, 2017Deflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE SUPERFICIAL FEMORAL ARTERY, THE ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AT UNSPECIFIED PRESSURE, BUT COULD NOT BE DEFLATED. NEGATIVE PRESSURE WAS PULLED SEVERAL TIMES TO ACHIEVE A PARTIAL DEFLATION TO RETRACT THE BALLOON INTO THE SHEATH AND THE DEVICE WAS REMOVED FROM THE ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6759097 ↗
• MalfunctionMay 11, 2017Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY. A 5.0 X 80 MM ARMADA 35 BALLOON CATHETER WAS INFLATED WITHOUT ISSUE, HOWEVER, IT COULD NOT DEFLATE. AFTER SEVERAL ATTEMPTS TO DEFLATE THE BALLOON, THE BALLOON PARTIALLY DEFLATED AND WAS ABLE TO BE REMOVED FROM THE ANATOMY WITHOUT ISSUE. ANOTHER BALLOON CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY IN PROCEDURE BUT IT WAS NOT CLINICALLY SIGNIFICANT AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6561854 ↗
• InjuryFeb 22, 2017Deflation Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE NON-TORTUOUS, NON-CALCIFIED, LEFT SUPERFICIAL FEMORAL ARTERY. THE 5MMX80MMX135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND WAS INFLATED WITHOUT ISSUE. HOWEVER, DURING DEFLATION THE BALLOON ONLY PARTIALLY DEFLATED. A BIGGER UNSPECIFIED BDC WAS ADVANCED AND INFLATED AND THE ARMADA BDC WAS RETRACTED WITHOUT ISSUE. AN UNSPECIFIED BDC WAS 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 Consequences Or Impact To Patient

  MAUDE report 6351585 ↗
• MalfunctionJan 25, 2017Deflation Problem; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH NO TORTUOSITY AND MODERATE CALCIFICATION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE ARMADA 35 BALLOON WAS SLOW TO INFLATE AND DURING DEFLATION, NEGATIVE PRESSURE WAS APPLIED FOR 10 MINUTES WITH DIFFERENT SYRINGES AND INFLATION DEVICES, BUT THE BALLOON NEVER COMPLETELY DEFLATED AND WAS PULLED THOUGH THE SHEATH PARTIALLY INFLATED. REPORTEDLY, THERE WAS RESISTANCE NOTED DURING REMOVAL OF THE PROTECTIVE SHEATH. AN ABSOLUTE PRO WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO 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 6277924 ↗