Armada B2050-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648155215), received between Jan 31, 2018 and Sep 2, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH CALCIFICATION. THE ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED BELOW NOMINAL PRESSURE. A NEW 5X120 MM ARMADA 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 22942635 ↗
• MalfunctionJun 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY. THE 5X120MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPPED PRIOR TO USE WITHOUT ISSUE. DURING THE PROCEDURE, WHEN INFLATING THE BDC A LEAK WAS NOTED. AFTER THE BDC WAS REMOVED, A SMALL HOLE WAS OBSERVED ON THE BALLOON. A NEW ARMADA 35 BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620324 ↗
• MalfunctionNov 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CALCIFIED, 100% STENOSED SUPERFICIAL FEMORAL ARTERY (SFA). THE 5X120 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED WHEN IT REACHED THE RATED BURST PRESSURE (RBP). THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144299 ↗
• MalfunctionFeb 23, 2023Deflation Problem; Inflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Inflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 5X120MM/135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS SLOW DURING INFLATION; HOWEVER, IT WAS USED FOR DILATATION OF THE LESION. AFTER DILATATION, THE BALLOON DEFLATED SLOW AND INCOMPLETE, DESPITE 10 TO 20 ATTEMPTS TO DEFLATE, HOLDING NEGATIVE FOR 10 TO 60 SECONDS FOR EACH DEFLATION ATTEMPT. THE SYRINGE WAS CHANGED BUT ONLY A SMALL VOLUME COULD BE SUCKED OUT OF THE BALLOON BY MANUALLY PULLING HARD ON THE SYRINGE SO THAT IT WOULD FIT THROUGH THE SHEATH. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16430922 ↗
• MalfunctionOct 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. A 5X12MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER BALLOON DILATATION CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655997 ↗
• MalfunctionJun 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED VESSEL WITHOUT TORTUOSITY IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.0X120MM ARMADA BALLOON CATHETER WAS SOAKED AND PREPARED (AIR ASPIRATED) OUTSIDE THE ANATOMY PRIOR TO USE AND ADVANCED TO THE TARGET LESION WITHOUT ISSUES. AT THE FIRST INFLATION, IT WAS ATTEMPTED TO INFLATE TO NOMINAL PRESSURE; HOWEVER, WHEN IT REACHED 4 ATMOSPHERES, IT WAS OBSERVED THAT THE BALLOON WAS NOT HOLDING PRESSURE AND CONTRAST WAS LEAKING [BALLOON RUPTURE] INTO THE VESSEL. THEREFORE, PRESSURE WAS REMOVED AND THE BALLOON DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. ANOTHER ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 14704298 ↗
• MalfunctionMay 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF A 5.0X120MM ARMADA 35 BALLOON CATHETER NEGATIVE PRESSURE WAS PULLED AND BUBBLES WERE NOTED, INDICATING A LEAK. THE BALLOON CATHETER WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER UNSPECIFIED ARMADA BALLOON CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795005 ↗
• MalfunctionAug 31, 2020Inflation Problem; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Split, Cut or Torn; Inflation Problem; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT SUPERIOR FEMORAL ARTERY (SFA). A 5.0X120MM ARMADA 35 CATHETER WAS ATTEMPTED TO BE ADVANCED, BUT THE BALLOON COULD NOT CROSS THE TORTUOUS ILIAC THROUGH LEFT COMMON FEMORAL ARTERY. THE PHYSICIAN RE-INSERTED SAME DEVICE THROUGH THE OTHER ACCESS SITE AND WAS ABLE TO ACCESS THE LESION WITH THE BALLOON VIA FOOT ACCESS. ONCE AT THE LESION UNKNOWN PRESSURE WAS ADDED ONCE, BUT THE BALLOON FAILED TO INFLATE. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. *DEVICE ANALYSIS NOTED THERE WERE MULTIPLE TEARS THROUGHOUT THE ENTIRE LENGTH OF THE BALLOON. *THE AFFILIATE CONFIRMED AT THE END OF THE PROCEDURE THERE WERE MULTIPLE TEARS VISIBLE THROUGHOUT THE ENTIRE LENGTH OF THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10474550 ↗
• MalfunctionMay 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED SUPERFICIAL FEMORAL ARTERY. A 5.0X120MM ARMADA 35 BALLOON BURST AT 14 ATMOSPHERES IN THE FIRST DILATATION. ANOTHER 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 Consequences Or Impact To Patient

  MAUDE report 10075464 ↗
• MalfunctionFeb 27, 2020Material 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 HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AN 5.0X120MM ARMADA 35 BALLOON WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) WITH NO ISSUES. THE BALLOON RUPTURED AT THE THIRD INFLATION AT 21 ATMOSPHERES, PREVIOUS TWO INFLATION'S WERE REPORTED AS NOMINAL INFLATIONS. IT WAS NOTED THE PHYSICIAN WAS AWARE OF INFLATING DEVICE ABOVE RATED BURST PRESSURE (RBP). A NEW UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9763914 ↗
• MalfunctionFeb 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 5.0X100MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITH NO RESISTANCE NOTED. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE DEVICE WAS REMOVED FROM THE ANATOMY WITH NO RESISTANCE AND REPLACED WITH A NEW BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8379753 ↗
• MalfunctionJan 31, 2018Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE 5X120 ARMADA 35 BALLOON RUPTURED AT 18 ATMOSPHERES AFTER 3 INFLATIONS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7231987 ↗