Armada 1013468-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648208171), received between Jun 1, 2017 and Feb 27, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE 5X40MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE PRESSURE WAS APPLIED TO THE BALLOON. THE BALLOON DID NOT INFLATE AND A HOLE IN THE BALLOON WAS SUSPECTED. THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER 5X40MM ARMADA 18 BDC WAS USED TO CONTINUE 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 18793564 ↗
• MalfunctionJul 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT IN-STENT RESTENOSIS WITH NO CALCIFICATION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.0 X 40 MM ARMADA 18 BALLOON CATHETER WAS ADVANCED WITHOUT ISSUE. THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATMS) DURING THE FIRST INFLATION. THE ARMADA 18 BALLOON CATHETER WAS REMOVED FROM THE PATIENT ANATOMY INTACT AND REPLACED WITH A 5.0 X 60 MM ARMADA 18 BALLOON CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203416 ↗
• MalfunctionSep 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. STANDARD PRE-DILATATION AND POST-DILATATION WERE PERFORMED, ALONG WITH LASER ATHERECTOMY. A 5X40MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED AT 4 ATMOSPHERES. AN UNSPECIFIED 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 Consequences Or Impact To Patient

  MAUDE report 10498043 ↗
• MalfunctionApr 13, 2018Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE ARMADA 018 BALLOON DILATATION CATHETER BECAME STUCK ON THE 018 STEEL CORE GUIDE WIRE DURING ADVANCEMENT TO THE UNCALCIFIED, NON-TORTOUS POPLITEAL ARTERY. THE ARMADA 018 WAS UNABLE TO BE REMOVED FROM THE GUIDE WIRE, SO BOTH WERE REMOVED FROM THE ANATOMY AS A UNIT. OUTSIDE THE ANATOMY, THE DEVICES WERE REMOVED FROM EACH OTHER. THE SAME GUIDE WIRE WAS USED WITH A NEW ARMADA 018 TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7430666 ↗
• MalfunctionJun 1, 2017Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY. A 5.0 X 40 MM ARMADA 18 BALLOON CATHETER WAS ADVANCED TO THE LESION; HOWEVER, WHEN INFLATING, THE CATHETER WOULD NOT HOLD PRESSURE. OUTSIDE THE ANATOMY THE BALLOON WAS PUT IN WATER AND INFLATED AND THERE WAS NO BALLOON RUPTURE NOTED BUT THE CATHETER STILL WOULD NOT HOLD PRESSURE . ANOTHER ARMADA 18 BALLOON CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6605319 ↗