Armada 1013465-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648207860), received between May 8, 2017 and May 31, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE TORTUOUS ILIAC ARTERY WHERE THERE WERE STENTS PRESENT AS WELL AS CALCIUM AND ANEURYSMS, VIA CONTRALATERAL APPROACH. THE 3X40 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED OVER A COMMAND GUIDE WIRE THROUGH A 6FR SHEATH. THE ARMADA BALLOON WAS UNABLE TO BE ADVANCED TO THE LESION AND WAS ALSO UNABLE TO BE REMOVED FROM THE GUIDE WIRE. THE DEVICES WERE REMOVED TOGETHER AND THE COMMAND GUIDE WIRE WAS ATTEMPTED TO BE RE-ADVANCED; HOWEVER, IT WAS NOT POSSIBLE TO RECROSS THE LESION AND THE PROCEDURE WAS ABORTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WILL COME BACK FOR ANOTHER PROCEDURE, ATTEMPTING ANTEGRADE APPROACH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19436083 ↗
• MalfunctionNov 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE 3.0X40MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT 4 ATMOSPHERES (ATM). THE BDC WAS REMOVED WITHOUT ISSUE AND A 7.0X40MM ARMADA 35 BDC WAS INFLATED TO 4 ATMS; HOWEVER, RUPTURED DURING THE FIRST INFLATION. THE ARMADA 35 BDC WAS REMOVED; HOWEVER, RESISTANCE WAS FELT WITH THE 6FR SHEATH. THE BALLOON WAS NOTED TO STILL REMAIN IN THE PATIENT. SNARING OF THE SEPARATED PORTION WAS ATTEMPTED; HOWEVER, NOT SUCCESSFUL. THE PATIENT WAS TAKEN INTO SURGERY TO REMOVE THE BALLOON; HOWEVER, IT IS UNKNOWN IF THE SEPARATED PORTION WAS SUCCESSFULLY REMOVED. THERE IS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749558 ↗
• MalfunctionAug 29, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE POPLITEAL ARTERY WITH HEAVY CALCIFICATION. A 3.0 X 40 MM ARMADA 18 BALLOON CATHETER WAS ADVANCED OVER AN UNSPECIFIED GUIDE WIRE AND CROSSED THE TARGET LESION. THEN WHEN THE BALLOON CATHETER WAS PRESSURIZED FOR THE FIRST INFLATION, BLOOD WAS OBSERVED COMING BACK IN THE INFLATION DEVICE [LEAK]. THE BALLOON DID NOT SEEM TO HOLD PRESSURE. THE BALLOON CATHETER WAS IMMEDIATELY REMOVED. ANOTHER UNSPECIFIED BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7828747 ↗
• MalfunctionMay 8, 2017Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.0 X 40 MM ARMADA 18 DILATATION CATHETER, AIR WAS PULLED BACK INTO THE SYRINGE AND IT WAS THOUGHT THAT THERE WAS A LEAK AT THE HUB. THE DEVICE WAS NOT USED IN THE PATIENT ANATOMY AND THERE WAS NO ADVERSE PATIENT EFFECT. A SECOND ARMADA 18 WAS USED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6553055 ↗