Armada B2060-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648155307), received between Apr 20, 2018 and Nov 3, 2025 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Material Rupture; Material Rupture

  THE PATIENT PRESENTED WITH LOWER LIMB ARTERIAL OCCLUSION. THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. ONCE AT THE LESION FOR DILATION, THE BALLOON OF A 6X120MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 14 ATMOSPHERES DURING THE FIRST INFLATION. AN UNSPECIFIED 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 23454575 ↗
• MalfunctionJul 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 6.0X120 MM ARMADA 35 DILATATION CATHETER WAS INFLATED IN THE SEVERELY CALCIFIED, MILDLY TORTUOUS, 80% STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY (SFA), BUT THE ARMADA RUPTURED WITH THE FIRST INFLATION AT 6 ATMOSPHERES DUE TO THE SEVERE CALCIUM. A NON-ABBOTT BALLOON WAS USED, BUT ALSO RUPTURED DUE TO THE SEVERE CALCIUM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES FROM THE BALLOON RUPTURE. THE PATIENT WAS REFERRED FOR BYPASS GRAFT SURGERY OF THE SFA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501349 ↗
• InjuryJun 4, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT EXTERNAL ILIAC ARTERY WITH HEAVY CALCIFICATION. A 6X80 MM SUPERA SELF EXPANDING STENT (SES) WAS DEPLOYED WITH NO ISSUES AND A NON-ABBOTT SES WAS USED TO EXTEND THE SUPERA STENT. WHILE DEPLOYING THE NON-ABBOTT SES, THE STENT BEGAN TO FLOWER AND THE WHEEL WAS CONTINUED TO BE TURNED. THE PHYSICIAN THEN BEGAN TO PULL THE STENT BACK ALONG WITH THE 7FR SHEATH, AND THE SYSTEM BECAME STUCK IN THE CALCIUM OF THE RIGHT ILIAC ARTERY. THE STENT BEGAN FLOWER MORE WHEN ATTEMPTING TO PULL BACK. APPROXIMATELY THREE OR MORE BALLOONS WERE USED IN AN ATTEMPT TO PULL THE STENT OUT - NUMEROUS NON-ABBOTT BALLOONS AND THE 6X120 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. THE ARMADA WAS ADVANCED THROUGH THE NON-ABBOTT SES AND THERE WAS RESISTANCE NOTED. THE BALLOON WAS INFLATED AND DEFLATED IN AN ATTEMPT TO GRAB THE STENT, BUT THE ARMADA PTA CATHETER SHEARED OFF IN THE PATIENT AFTER THERE WAS RESISTANCE WITH THE NON-ABBOTT SES DURING REMOVAL AND FORCE WAS APPLIED. A SNARE WAS USED TO RETRIEVE THE ARMADA BALLOON. THE SNARE WAS THEN USED IN AN ATTEMPT TO SNARE AND RETRIEVE THE STENT AND SYSTEM. DURING THE LAST ATTEMPT TO RETRIEVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145282 ↗
• MalfunctionOct 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING THE PROCEDURAL PREPARATION OF A 6X120MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), WHEN NEGATIVE PRESSURE WAS APPLIED, BUBBLES WERE NOTED AND A RUPTURE WAS IDENTIFIED ON THE BALLOON. ANOTHER DILATION CATHETER WAS USED AND THE PROCEDURE WAS COMPLETED. 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 20395245 ↗
• MalfunctionJan 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION WITHIN AN ATRIOVENTRICULAR FISTULA WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 6.0X120MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND INFLATED ONCE AT 12 ATMOSPHERES (ATMS), HOWEVER, A RUPTURE OCCURRED. ANOTHER SAME SIZE ARMADA 35 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 18504315 ↗
• InjurySep 15, 2023Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED TOTAL OCCLUSION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X120MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITHOUT RESISTANCE, BUT DURING INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES. RESISTANCE WAS MET WHEN TRYING TO REMOVE THE BDC, SO FORCE WAS APPLIED AND THE SHAFT SEPARATED AROUND THE MID SEGMENT. THE PATIENT WAS SENT TO SURGERY TO REMOVE THE SEPARATED PORTION OF THE BALLOON CATHETER, RESULTING IN A CLINICALLY SIGNIFICANT DELAY IN TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760285 ↗
• InjuryMay 2, 2023Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUPERIOR FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION AND 80% STENOSIS. THE ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED AND INFLATED TO 20 ATMOSPHERES (ATM), BUT THE BALLOON RUPTURED. DURING REMOVAL, THE DEVICE BECAME CAUGHT ON THE GUIDE CATHETER AND THE TIP SEPARATED. THE TIP WAS ATTEMPTED TO BE SNARED, BUT THIS WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO SURGERY FOR ENDARTERECTOMY. THERE WAS ADDITIONAL HOSPITALIZATION FOR THE PATIENT DUE TO THE TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16857515 ↗
• MalfunctionJan 31, 2023Inflation Problem; Leak/Splash; Material Split, Cut or Torn; Inflation Problem; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN IN-STENT RESTENOSIS WITH STENT FRACTURE OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80% STENOSIS. THE 6.0X120MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE AND THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH. THE BDC WAS ADVANCED AND THE BALLOON WAS PRESSURIZED AT 10 ATMOSPHERES (ATMS) BUT COULD NOT BE INFLATED. THE BDC WAS REMOVED. ANOTHER 6.0X120MM ARMADA 35 BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED A LONGITUDINAL TEAR ON THE BALLOON NOTED IN TWO LOCATIONS PROXIMAL TO THE DISTAL BALLOON MARKER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272319 ↗
• MalfunctionDec 22, 2022Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 6.0X120MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED, HOWEVER, THERE WAS RESISTANCE DURING WITHDRAWAL OF THE BALLOON OVER THE INTRODUCER. IT WAS NOTED THAT THE DELIVERY CATHETER WAS STRETCHED AND TRAPPED THE WIRE INSIDE IT. THE BALLOON WAS INFLATED TWICE UNDER NOMINAL PRESSURE AND NEGATIVE WAS HELD AROUND 3-5 SECONDS. THERE WAS NO DEFLATION ISSUE REPORTED AND THE BALLOON WAS WITHDRAWN COMPLETELY DEFLATED. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH. THE DEVICE WAS NOT PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THE CONTRAST MIX WAS 40% CONTRAST AND 60% HEPARIN FLUID. UNDER ACTIVE ASPIRATION, ALL DEVICES WERE REMOVED AS A SINGLE UNIT. ANOTHER ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. A SECOND DEVICE WAS STRETCHED IN THE SAME WAY BUT IT WAS DURING MANIPULATION AT THE BACK TABLE AND IT WAS AFTER IT WAS SUCCESSFULLY USED AND REMOVED FROM THE PATIENT. THE SECOND DEVICE HAD NO ISSUES AND THE PHYSICIAN PERFORMED A CATHETER STRESS TENSION TEST ON THE TABLE AFTER USE WITH THE SAME RESULT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16034568 ↗
• MalfunctionJun 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. AFTER LASER ATHERECTOMY WAS PERFORMED, A 6X120MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATMS). THEN, A 6X120MM ARMADA 35 PTA CATHETER WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMS. A NON-ABBOTT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12067792 ↗
• InjuryApr 20, 2021Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance; Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED, HEAVILY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. A 6X120MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED AND FELT RESISTANCE WITH THE ANATOMY AND AN UNSPECIFIED 6F INTRODUCER SHEATH. THE BALLOON RUPTURED ON THE THIRD INFLATION AT 7 OR 8 ATMOSPHERES. THE PTA CATHETER HAD DIFFICULTY BEING REMOVED WITH AN UNSPECIFIED 6F INTRODUCER SHEATH, SO THE DEVICES WERE REMOVED TOGETHER. THE BALLOON SEPARATED IN THE ANATOMY, AND THE SEPARATED PORTION WAS SURGICALLY REMOVED. THE PATIENT IS FINE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694612 ↗
• MalfunctionOct 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. A 6X120MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON WAS INFLATED ONCE TO NOMINAL PRESSURE WHEN A PINHOLE RUPTURE WAS NOTED IN THE BALLOON. THE PTA WAS REMOVED WITHOUT ISSUE, AND A 6X80MM ARMADA PTA 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 10690831 ↗
• MalfunctionApr 20, 2018Torn Material

  IT WAS REPORTED THAT AN UNSPECIFIED GUIDE WIRE WAS ADVANCED IN THE PATIENT, AND WHEN A 6.0 X 120 MM ARMADA 35 BALLOON CATHETER WAS PLACED OVER THE GUIDE WIRE, THE WIRE CAME OUT OF THE MID SHAFT OF THE BALLOON CATHETER. REPORTEDLY, A MICRO HOLE IN THE MID SHAFT WAS NOTED, BUT NO LEAK. THE BALLOON DID NOT ENTER THE PATIENT. ANOTHER UNSPECIFIED BALLOON CATHETER WAS ADVANCED OVER THE GUIDE WIRE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7447359 ↗