Armada 1013470-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08717648208416), received between Oct 27, 2016 and Nov 5, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) LESION. A 6.0X80 MM X150 CM ARMADA 18 (BDC) WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE, WITHOUT ANY ISSUES. NO RESISTANCE MET DURING ADVANCEMENT, HOWEVER, THE BDC RUPTURED DURING THE FIRST INFLATION AT APPROXIMATELY 1 TO 2 ATMOSPHERES. THEREFORE, THE BDC WAS REMOVED WITHOUT ISSUE IN ONE PIECE AND THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT 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 23480577 ↗
• MalfunctionOct 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A SEVERELY STENOSED LESION IN A SUPERFICIAL FEMORAL ARTERY (SFA). A 6X80MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER DURING THE FIRST INFLATION TO 4ATMS THE BALLOON WAS NOTED TO RUPTURE. THEREFORE THE BDC WAS REPLACED WITH ANOTHER ARMADA BDC AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375768 ↗
• MalfunctionJun 17, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, SUPERFICIAL FEMORAL ARTERY. DURING ADVANCEMENT OF A 6.0X60MM ARMADA 18 BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET DUE TO THE INTRODUCER SHEATH. ONCE AT THE LESION, THE ARMADA BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION AND REMOVED. A 6.0X80MM ARMADA 18 BDC WAS USED AND ALSO MET RESISTANCE WITH THE SHEATH. ONCE AT THE LESION, THE 6.0X80MM ARMADA BDC ALSO RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION AND THEN REMOVED. AN UNSPECIFIED ARMADA BDC 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 22243174 ↗
• MalfunctionOct 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT EXTERNAL ILLIAC ARTERY WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE 6X80 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. THE 6X60 MM ARMADA 35 PTA CATHETER WAS USED INSTEAD; HOWEVER, IT ALSO RUPTURED ON THE FIRST INFLATION TO 5 ATMOSPHERES. A NEW NON-ABBOTT 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 20533973 ↗
• MalfunctionOct 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON OF THE 6.0X80MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED DURING THE PROCEDURE AT AN UNKNOWN PRESSURE. ANOTHER BALLOON DILATATION 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15628933 ↗
• MalfunctionAug 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY WITH MODERATE CALCIFICATION. THE 5.00X200MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND DURING INFLATION TO NOMINAL PRESSURE THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE FROM THE PATIENT. THEN, A 6.00X80MM ARMADA BDC WAS ADVANCED TO THE TARGET LESION AND DURING INFLATION FOR 1 MINUTE, THE BALLOON RUPTURED BEFORE REACHING NOMINAL PRESSURE. THE DEVICE WAS REMOVED, WITHOUT ISSUE, FROM PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. TWO ABBOTT BALLOONS WERE USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15168387 ↗
• MalfunctionJun 6, 2022Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HIGHLY CALCIFIED SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. A COMMAND GUIDE WIRE (GW) WENT DOWN, EARLY IN THE CASE BUT THERE WAS NOTED RESISTANCE WITH ANATOMY WHILE ADVANCING IT TO THE LESION, ALTHOUGH IT WAS ABLE TO REACH THE LESION. IT WAS NOTICED THAT THE TIP OF THE WIRE WAS MANGLED/FRAYED ONCE THE GW WAS REMOVED AFTER THE COMPLETION OF THE CASE. THE GW BECAME DAMAGED FROM THE CALCIUM. THE ARMADA 18 BALLOON WAS TAKEN IN AND OUT NUMEROUS TIMES DURING THE PROCEDURE AS IT WAS INFLATED TO NOMINAL PRESSURE SIX TIMES; HOWEVER, ON THE 7TH TIME, BUT THE COMMAND GW WOULD NOT ADVANCE THROUGH THE ARMADA BALLOON. THERE WERE NO DAMAGES NOTED TO THE ARMADA BALLOON A NEW ARMADA WAS SUCCESSFULLY USED FOR THE 7TH INFLATION TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. DEVICE ANALYSIS NOTED THAT THE ARMADA 18 BALLOON [THE MATERIAL ON THE PROXIMAL BALLOON MARKERS WAS TORN FOR A LENGTH OF 2.5MM]. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14610756 ↗
• MalfunctionMar 30, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CALCIFIED MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH NO TORTUOSITY. BOTH ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS RUPTURED ON THE FIRST INFLATION TO 9 ATMOSPHERES. THERE WAS NO RESISTANCE DURING ADVANCEMENT. THE DEVICES WERE PREPPED PER THE INSTRUCTIONS FOR USE (IFU). ANOTHER ARMADA PTA CATHETER 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 13955466 ↗
• MalfunctionOct 14, 2021Failure to Fold; Defective Device; Difficult to Advance; Failure to Fold; Defective Device; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), MILDLY CALCIFIED LESION. AN ARMADA DILATATION CATHETER ADVANCED TO THE LESION WITHOUT ISSUE AND DILATATION WAS PERFORMED. DURING INFLATION, THE PROXIMAL SHOULDER OF THE BALLOON, BEYOND THE MARKERS, APPEARED LONGER THAN EXPECTED AT 10-15MM. THE DEVICE WAS REMOVED WITHOUT ISSUE AND A STENT PLACED. THE SAME ARMADA DILATATION CATHETER WENT TO ADVANCE; HOWEVER, RESISTANCE DURING ADVANCEMENT WAS FELT WITHIN THE SHEATH. REPORTEDLY, THE SAME ARMADA BALLOONS RE-WRAP (FOLDING) DID NOT APPEAR NORMAL. THE DEVICE WAS REMOVED WITHOUT ISSUES AND ANOTHER DEVICE WAS SUCCESSFULLY USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632906 ↗
• MalfunctionApr 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY. NO CALCIFICATION OR TORTUOSITY WAS NOTED. ATHERECTOMY WAS PERFORMED AND THEN 3 ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS WERE USED. TWO ARMADA 18 6.0X120 MM PTA CATHETERS RUPTURED ON THE FIRST INFLATION TO 7 OR 8 ATMOSPHERES (ATM), AND AN ARMADA 18 6.0X80 MM PTA CATHETER ALSO RUPTURED ON THE FIRST INFLATION TO 7 OR 8 ATM. THERE WAS NO NOTED RESISTANCE DURING ADVANCEMENT OR REMOVAL. A NON-ABBOTT BALLOON WAS USED LAST AND ALSO RUPTURED. A SUPERA SELF-EXPANDING STENT WAS THEN SUCCESSFULLY DEPLOYED 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 11735379 ↗
• MalfunctionAug 22, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION, TREATING THE PROXIMAL-MID SUPERFICIAL FEMORAL ARTERY (SFA). AN UNSPECIFIED 80MM STENT WAS IMPLANTED. FOLLOWING, THE ARMADA DILATATION CATHETER ADVANCED TO THE STENT FOR POST-DILATATION. ONCE AT THE STENT, THE BALLOON WAS STICKING OUT OF THE STENT AND THE BALLOON WAS DEEMED LONGER THAN EXPECTED. THE IMPLANTED STENT WAS 80MM AND THE BALLOON LENGTH WAS ALSO 80MM AND THE OPERATOR STATED THE BALLOON SHOULD NOT HAVE BEEN OBSERVED AS LONGER THAN THE STENT. THE BALLOON SUCCESSFULLY POST-DILATED THE STENT WITHOUT A DEVICE ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8922296 ↗
• MalfunctionMay 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. DURING USE OF TWO 6.0X80MM ARMADA 18 BALLOON DILATATION CATHETERS (BDC) BOTH RUPTURED AT 8 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 Consequences Or Impact To Patient

  MAUDE report 8593325 ↗
• MalfunctionMay 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. DURING USE OF TWO 6.0X80MM ARMADA 18 BALLOON DILATATION CATHETERS (BDC) BOTH RUPTURED AT 8 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 Consequences Or Impact To Patient

  MAUDE report 8593311 ↗
• MalfunctionMar 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA), THREE DIFFERENT ARMADA 18 BALLOON DILATATION CATHETERS (BDC) WERE USED; EACH RUPTURED DURING THE FIRST INFLATION AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT BDC WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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 8394616 ↗
• MalfunctionAug 13, 2018Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY STENOSED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH NO TORTUOSITY AND HEAVY CALCIFICATION. A 6.0MM X 80MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED TO THE LESION WITH RESISTANCE FROM THE ANATOMY VIA A RETROGRADE APPROACH. THE BALLOON OF THE PTA BALLOON CATHETER RUPTURED ON THE FIRST INFLATION AT 8 ATMOSPHERES. AN ADDITIONAL NON-ABBOTT BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITH RESISTANCE FROM THE ANATOMY AND THE BALLOON RUPTURED AT NOMINAL PRESSURE. NO FURTHER INTERVENTION WAS PERFORMED DURING THE PROCEDURE AND NO FURTHER INTERVENTION IS PLANNED FOR THE LESION. 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 7777948 ↗
• MalfunctionNov 4, 2016Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0 X 80 MM ARMADA 18 WAS ADVANCED TO THE TARGET LESION, BUT RUPTURED AT 8 ATMOSPHERE (ATM) DURING THE FIRST INFLATION. A 5.5 X 100 MM ARMADA 18 WAS ADVANCED TO THE TARGET LESION BUT RUPTURED AT 8 ATM DURING THE FIRST INFLATION AS WELL. A 4.0 X 12 MM ARMADA 14 WAS ADVANCED TO THE TARGET LESION; HOWEVER, A RUPTURE OCCURRED AT UNKNOWN PRESSURE DURING THE FIRST INFLATION. ANOTHER NEW ARMADA 14 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 6080848 ↗
• MalfunctionOct 27, 2016Material Rupture

  IT WAS REPORTED DURING A PROCEDURE THE ARMADA 18 RUPTURED AT 8 ATMOSPHERES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN PROCEDURE OR ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6062501 ↗