Armada 1013469-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648208317), received between Nov 4, 2016 and Nov 1, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT TWO 5.5X100MM AND 5.5X200MM ARMADA 18 BALLOON DILATATION CATHETER RUPTURED BOTH AT 10 ATMOSPHERES DURING THE FIRST INFLATION. AN UNSPECIFIED HIGH PRESSURE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048611 ↗
• 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 13019396 ↗
• MalfunctionMar 12, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.5X100MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE. THE BALLOON WAS INFLATED THREE TIMES TO 12 ATMOSPHERES WHEN THE BALLOON RUPTURED. THE PTA WAS REMOVED, AND A 6X120MM ARMADA 18 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 11477905 ↗
• InjuryNov 6, 2017Difficult To Position; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. THE 5.5MMX100MMX150 CM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER A 018 STEELCORE GUIDE WIRE, AND BALLOONING WAS PERFORMED. WHEN ATTEMPTING TO REMOVE THE ARMADA BDC, RESISTANCE WAS FELT WITH THE GUIDE WIRE AND THE SHEATH. WHEN TRYING TO RE-ADVANCE, THE BDC COULD NOT BE ADVANCED ON THE GUIDE WIRE. BOTH THE BDC AND GUIDE WIRE COULD NOT BE ADVANCED PAST THE SHEATH. EVENTUALLY, THE BDC WAS PULLED OUT OF THE PATIENT ENOUGH TO WHERE THE GUIDE WIRE COULD BE SEEN; AND THE GUIDE WIRE HAD TO BE CLAMPED TO CONTINUE REMOVING THE BDC OFF THE GUIDE WIRE. ANOTHER GUIDE WIRE AND ARMADA WERE USED SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7003113 ↗
• 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 6080854 ↗