Armada B2060-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648155314), received between May 26, 2017 and Mar 26, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionMar 26, 2026Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. FOR PRE-DILATION, THE 6X150MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED WITHOUT ISSUE; HOWEVER, AFTER STENTING WHEN ATTEMPTING TO REINTRODUCE THE BDC FOR POST-DILATION, THE BDC MET WITH RESISTANCE WITH THE 6FR INTRODUCER SHEATH AND THE SHAFT OF THE BDC BECAME KINKED. THEREFORE, THE BDC WAS REMOVED AND DURING REMOVAL THE BDC MET RESISTANCE WITH THE INTRODUCER SHEATH. A NON-ABBOTT BDC 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 24701652 ↗
• MalfunctionDec 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AFTER A 6X150MM ARMADA 35 BALLOON DILATATION WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU), IT WAS ADVANCED TO THE LESION OVER A .035 WIRE; HOWEVER, DURING ITS FIRST INFLATION ATTEMPT TO NOMINAL PRESSURE A LEAK WAS NOTED AT THE HUB. THE DEVICE WAS REMOVED AND REPLACED WITH A 6X120MM ARMADA AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAYS. NO ADDITIONAL INFORMATION WAS PROVIDED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917588 ↗
• InjuryDec 5, 2024Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Material Separation; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X150MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED HOWEVER MET RESISTANCE WITH A DISSECTED PLANE OF THE LESION THEREFORE IT WAS PULLED BACK HOWEVER IT APPEARED THE SHAFT HAD FOLDED OVER ON ITSELF AND KINKED. THE BDC WAS REMOVED AND IT WAS NOTED THE BALLOON HAD SEPARATED AND REMAINED ON THE GUIDE WIRE. A SNARE DEVICE WAS USED TO REMOVE THE SEPARATED PORTION OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 20852238 ↗
• MalfunctionOct 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY WITH NO CALCIFICATION OR TORTUOSITY. THE 6X150 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION AND INFLATED ONCE BUT RUPTURED AT 6 ATMOSPHERES. A NON-ABBOTT BALLOON 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 20359706 ↗
• MalfunctionFeb 14, 2024Break; Inflation Problem; Leak/Splash; Break; Inflation Problem; Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 80% STENOSED LEFT SUPERIOR FEMORAL ARTERY (SFA) LESION. A 6MMX150MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. A NON-ABBOTT INFLATION DEVICE WAS CONNECTED TO THE BDC, AND ATTEMPTED TO INFLATE THE BALLOON; HOWEVER, THE BALLOON WOULD NOT INFLATE. THE BDC WAS REMOVED WITHOUT ISSUE. OUTSIDE THE PATIENT ANATOMY A CRACK IN THE HUB WAS NOTED WHICH RESULTED IN A LEAK FROM THE CRACK AND THE REASON THAT THE BALLOON WOULD NOT INFLATE. THERE WAS NO PHYSICAL ISSUE WITH THE ACTUAL BALLOON ITSELF, ONLY THE HUB. A NEW ARMADA BDC WAS USED SUCCESSFULLY FOR 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 18704426 ↗
• MalfunctionSep 8, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT PERITONEAL TRUNK ARTERY WITH MODERATE CALCIFICATION. THE 6X150 ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION AND INFLATION TO NOMINAL PRESSURE WAS ATTEMPTED; HOWEVER, THE BALLOON WOULD NOT INFLATE AT ALL. THE DEVICE WAS REMOVED AND A NEW, SAME SIZE ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE BALLOON INFLATED BUT WAS UNABLE TO MAINTAIN PRESSURE DUE TO FLUID LEAKING AT THE PROXIMAL END OF THE SIDEARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15385542 ↗
• MalfunctionDec 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH MONCKEBERG SCLEROSIS IN THE AORTA WITH RUNOFF IN PERIPHERAL VESSELS AND HEAVY CALCIFICATION. THAT DAY, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE RIGHT POPLITEAL AND RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) CONTAINING THIS HEAVY/JAGGED CALCIFICATION. USING A 6 FRENCH SHEATH, AN HT COMMAND GUIDE WIRE ADVANCED THROUGH THE ACUTE/STEEP ILIAC BIFURCATION WITHOUT ISSUES. FOLLOWING, AN ARMADA 18 AND AN ARMADA 35 BALLOON DILATATION CATHETER HAD ADVANCED WITHOUT ISSUES. UPON FIRST INFLATION ATTEMPT, BOTH BALLOONS HAD RUPTURED BELOW RATED BURST PRESSURE DUE TO THE HEAVY, JAGGED CALCIFICATION. THE CATHETERS WERE REMOVED WITHOUT ISSUE AND ANOTHER DEVICE WAS USED IN REPLACEMENT. THE FIRST SUPERA STENT WAS SUCCESSFULLY IMPLANTED. FOLLOWING, A SECOND SUPERA STENT DELIVERY ADVANCED WITH DIFFICULTY/RESISTANCE NOTED WITH THE COMMAND WIRE, ONCE AT THE STEEP BIFURCATION. THE SUPERA HAD THEN BECOME STUCK ON THE WIRE AND WAS UNABLE TO ADVANCE OR BE REMOVED. BOTH WERE REMOVED AS A SINGLE UNIT (THE WIRE AND SUPERA SDS). ANOTHER DEVICE WAS USED IN REPLACEMENT, COMPLETING THE PROCEDURE, WITHOUT FURTHER ISSUES NOTED. THERE WERE NO ADVERSE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019434 ↗
• MalfunctionSep 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A 50% STENOSED, MILDLY TORTUOSITY, AND MODERATELY CALCIFIED DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0X150MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPPED OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUES. THE BDC WAS ADVANCED WITHOUT RESISTANCE AND THE BALLOON WAS INFLATED ONCE; HOWEVER, RUPTURED BELOW PRESSURE AT 14 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SAME SIZE ARMADA 35 BDC. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10530301 ↗
• MalfunctionMay 21, 2019Material 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 MILDLY TORTUOUS FEMORAL VEIN. A 6.0 X 150 MM ARMADA 35 BALLOON CATHETER WAS USED. HOWEVER, IT WAS NOT PREPPED OUTSIDE THE ANATOMY PRIOR TO USE AND AN AIR LEAK IN THE BALLOON WAS NOTED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THEREFORE, ANOTHER 6.0 X 150 MM ARMADA 35 BALLOON CATHETER 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 8629930 ↗
• MalfunctionMay 26, 2017Leak/Splash

  IT WAS REPORTED THAT DURING AN INTERVENTION IN THE SUPERFICIAL FEMORAL ARTERY, DURING THE FIRST INFLATION, FLUID WAS NOTED LEAKING AT THE HUB OF THE ARMADA 35 AND IT WOULD NOT HOLD PRESSURE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER ARMADA 35 WITHOUT FURTHER INCIDENT. 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 6594079 ↗