Armada 1013470-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648208393), received between May 25, 2017 and Feb 4, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Material Rupture

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT AN UNKNOWN VESSEL. AN ARMADA 18 WAS INSERTED AND INFLATED TWO TIMES WITHOUT ISSUES. HOWEVER, DURING REMOVAL, BLOOD CAME BACK INTO THE INFLATION DEVICE, AND A HOLE WAS OBSERVED IN THE BALLOON NEAR THE CATHETER TIP END. THE DEVICE WAS REMOVED WITHOUT FURTHER ISSUES. 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 24262212 ↗
• MalfunctionJan 15, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT ILIAC ARTERY WITH MODERATE CALCIFICATION. THE 6X40MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION, AND THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, CONTRAST WAS NOTED TO BE COMING FROM THE BALLOON. THEREFORE, THE BALLOON REMOVED FROM THE PATIENT A PINHOLE [BALLOON RUPTURE] WAS NOTED ON THE BALLOON. ANOTHER ARMADA 18 BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE 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 24080815 ↗
• MalfunctionNov 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE 6X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED. HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THEN, A 6X40MM ARMADA 18 BDC WAS ADVANCE TO THE TARGET LESION AND THE BALLOON WAS INFLATED. HOWEVER, THE SECOND ARMADA BALLOON ALSO RUPTURED AT 10 ATM DURING THE FIRST INFLATION. THEREFORE, THE SECOND ARMADA BALLOON WAS REMOVED FROM THE PATIENT. ANOTHER 6X40MM ARMADA BALLOON WAS USED TO COMPLETE 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 23586440 ↗
• MalfunctionAug 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY. THE 5.0X120MM, 5.0X150MM ARMADA 35 BALLOON DILATATION CATHETERS RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATM). A 7.0X100MM ABSOLUTE PRO STENT WAS THEN DEPLOYED IN THE TARGET LESION. A 6.0X40MM ARMADA 35 WAS USED TO POST DILATE THE STENT HOWEVER ALSO RUPTURED DURING THE FIRST INFLATION AT 10 ATM. 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 22883916 ↗
• InjurySep 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE 6X40 MM ARMADA 35 PTA CATHETER RUPTURED DURING THE FIRST INFLATION AT 8 ATM. THE 6X40 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS OF THE ARMADA 18 PTA CATHETER IDENTIFIED THAT THE BALLOON INNER MEMBER AND TIP AND MARKERS WERE SEPARATED FROM THE DEVICE AND NOT RETURNED. THE ACCOUNT WAS NOT AWARE OF THE SEPARATION. THERE IS THE POTENTIAL THAT SOME MATERIAL REMAINED IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20184452 ↗
• MalfunctionMay 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE 100% OCCLUSION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY THAT WAS MODERATELY CALCIFIED. DURING PRE-DILATATION, THE 6.0X40X150CM ARMADA 18 BALLOON RUPTURED AT 11 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. A NEW ARMADA WAS USED WITHOUT ISSUE AND STENT WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345951 ↗
• MalfunctionMar 8, 2018Leak/Splash

  IT WAS REPORTED THAT WHILE BACKLOADING THE ARMADA 18 BALLOON DILATATION CATHETER (BDC) ONTO THE GUIDE WIRE, NEGATIVE PRESSURE WAS APPLIED AND AIR BUBBLES WERE NOTED AT THE PROXIMAL END. THE DEVICE WAS REMOVED AND NOT USED IN THE ANATOMY. A DIFFERENT ARMADA 35 BDC WAS USED SUCCESSFULLY IN THE PROCEDURE, 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 7325661 ↗
• MalfunctionMay 25, 2017Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT COMMON FEMORAL ARTERY. DURING THE FIRST INFLATION OF THE 6MMX40MMX150CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) TO 10 ATMOSPHERES, A LEAK WAS NOTED AT THE DISTAL END OF THE STRAIN RELIEF TUBE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW ARMADA 18 BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6591225 ↗