Armada F2015-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648182884), received between Jul 17, 2017 and Nov 12, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED ANTERIOR TIBIAL ARTERY THAT IS 85% STENOSED. THE BALLOON OF A 1.5X20MM ARMADA 14 XT BALLOON DILATATION CATHETER (BDC), BURST AT 10 ATMOSPHERES DURING THE FIRST INFLATION. A NEW ARMADA 14 XT 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 23535003 ↗
• MalfunctionMay 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION. THE 1.5X20 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO 12 ATMOSPHERES AND RUPTURED. ANOTHER 1.5X20 MM ARMADA 14 PTA CATHETER WAS INFLATED ONCE TO 10 ATMOSPHERES AND RUPTURED. ANOTHER ARMADA 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 22089577 ↗
• MalfunctionMay 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION. THE 1.5X20 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO 12 ATMOSPHERES AND RUPTURED. ANOTHER 1.5X20 MM ARMADA 14 PTA CATHETER WAS INFLATED ONCE TO 10 ATMOSPHERES AND RUPTURED. ANOTHER ARMADA 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 22089565 ↗
• MalfunctionOct 28, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE ARMADA 14 WAS ATTEMPTED TO BE BACKLOADED ON THE HT COMMAND ES GUIDEWIRE. THERE WAS NO RESISTANCE DURING REMOVAL OF THE GUIDEWIRE FROM THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543804 ↗
• MalfunctionMay 23, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN OCCLUSION IN THE RIGHT PERONEAL ARTERY. THE 1.5X20MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE WITH THE HT COMMAND ES 300CM GUIDE WIRE (GW); HOWEVER, THE BDC AND THE GW BECAME STUCK TOGETHER DURING REMOVAL. THEREFORE, THE BDC AND THE GW HAD TO BE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NEW BDC AND GW WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19383425 ↗
• MalfunctionMay 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE 1.5X20MMX145CM ARMADA 14 OVER THE WIRE (OTW) BALLOON DILATATION CATHETER (BDC) WAS BEING USED IN A PROCEDURE WHEN AN UNSPECIFIED GUIDE WIRE (GW) PERFORATED THE BALLOON, AND IT COULD NOT PROPERLY FILL WITH CONTRAST. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16969154 ↗
• MalfunctionApr 26, 2023Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

  SUBSEQUENT TO INITIAL REPORT BEING FILED THE RETURN DEVICE ANALYSIS FOUND THE INNER MEMBER AND OUTER MEMBER WERE SEPARATED IN MULTIPLE LOCATIONS THROUGHOUT THE BDC. THE BDC WAS RETURNED IN FIVE SEPARATE PIECES. THE BALLOON HAD BEEN INFLATED THE ACCOUNT CONFIRMED THE CORRECT DEVICE WAS RETURNED AND THE SEPARATION AND BALLOON INFLATION OCCURRED OF POST-PROCEDURE MANIPULATION AND NOT IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16818845 ↗
• MalfunctionAug 19, 2021Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED, HEAVILY CALCIFIED, MILDLY TORTUOUS, CHRONIC TOTALLY OCCLUDED (CTO) LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 1.5X20 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS NOT AIR ASPIRATED OUTSIDE THE ANATOMY PRIOR TO USE IN THE PATIENT. THE DEVICE WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY AND WAS INFLATED TWICE TO 8 ATMOSPHERES (ATM). THE BALLOON RUPTURED AND WOULD NOT INFLATE A THIRD TIME. A 1.5X40 MM ARMADA 14 PTA CATHETER WAS USED IN REPLACEMENT. 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 12344440 ↗
• MalfunctionJul 23, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LOWER EXTREMITIES. A 1.5X20MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS USED WITH A COMMAND 14 GUIDE WIRE. THE DEVICES CROSSED SUCCESSFULLY, AND THE PTA BALLOON WAS USED. HOWEVER, THE GUIDE WIRE WAS STUCK WITH THE PTA CATHETER, SO THE DEVICES WERE REMOVED TOGETHER. AN UNSPECIFIED GUIDE WIRE AND BALLOON WERE 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 12221343 ↗
• MalfunctionAug 9, 2019Leak/Splash; Difficult to Advance; Material Split, Cut or Torn; Leak/Splash; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION WITH CHRONIC TOTAL OCCLUSION IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS, 100% STENOSED RIGHT ANTERIOR TIBIAL ARTERY. AFTER PLACEMENT OF THE 1.5X20MM ARMADA 14 XT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, THE GUIDE WIRE WAS EXCHANGED FOR A HI TORQUE WINN 200T, 300CM GUIDE WIRE. DURING ADVANCEMENT, THE GUIDE WIRE MET RESISTANCE NEGOTIATING THE NATURAL CURVE OF THE PROXIMAL ANTERIOR TIBIAL ARTERY WHILE PUSHING THROUGH THE ARMADA CATHETER AND PUNCTURED THE CATHETER. ALTHOUGH THE CATHETER WAS NOT INFLATED AT ANY TIME, BLOOD WAS OBSERVED IN THE INFLATION LUMEN AND THE HUB. NEW DEVICES WERE 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 8880145 ↗
• MalfunctionSep 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE MILDLY TORTUOUS, MILDLY CALCIFIED, 85% STENOSED, DE NOVO, DISTAL POSTERIOR TIBIAL ARTERY, THE 1.5 X 20 MM ARMADA 14XT BALLOON DILATATION CATHETER (BDC) WAS USED AND DURING THE FIRST INFLATION NEAR NOMINAL PRESSURE OF 8 ATMOSPHERE (ATM), THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE VESSEL. A DIFFERENT ARMADA 14XT BDC WAS USED TO COMPLETE THE PROCEDURE WITHOUT REPORTED EVENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7861606 ↗
• MalfunctionJul 17, 2017Leak/Splash

  IT WAS REPORTED THAT DURING A PERIPHERAL PROCEDURE, THE 1.5 X 20 MM ARMADA 14 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION IN THE ANTERIOR TIBIAL ARTERY. DURING THE FIRST INFLATION, FLUID WAS LEAKING OUT OF A SMALL HOLE IN THE HUB. THE ARMADA 14 WAS ABLE TO FULLY INFLATE AND DEFLATE, AND DILATATION WAS COMPLETED USING THE DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6719699 ↗