Armada 1013470-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648208409), received between Jan 23, 2017 and Jun 17, 2025 — 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.

• MalfunctionJun 17, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, SUPERFICIAL FEMORAL ARTERY. DURING ADVANCEMENT OF A 6.0X60MM ARMADA 18 BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET DUE TO THE INTRODUCER SHEATH. ONCE AT THE LESION, THE ARMADA BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION AND REMOVED. A 6.0X80MM ARMADA 18 BDC WAS USED AND ALSO MET RESISTANCE WITH THE SHEATH. ONCE AT THE LESION, THE 6.0X80MM ARMADA BDC ALSO RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION AND THEN REMOVED. AN UNSPECIFIED ARMADA 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 22243246 ↗
• InjuryJun 13, 2025Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT IN STENT RESTENOSIS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6X60MM ARMADA 18 BALLOON DILATION CATHETER (BDC) WAS USED IN THE PROCEDURE WITH A 1/3 CONTRAST TO 2/3 SALINE RATIO. POST BALLOON DILATATION, THE BALLOON WAS ONLY ABLE TO BE PARTIALLY DEFLATED AND DURING REMOVAL OF THE BDC RESISTANCE WAS NOTED; THEREFORE, A 20CC SYRINGE WAS USED TO WITHDRAW AIR FROM THE BALLOON. WHEN THE BDC WAS OUTSIDE THE PATIENT THE BALLOON WAS NOTED TO HAVE BECOME SEPARATED FROM THE DELIVERY CATHETER. THEREFORE, A SNARE WAS USED TO RETRIEVE THE SEPARATED BALLOON. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203345 ↗
• MalfunctionDec 2, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SEVERELY STENOSED LESION IN THE LEFT COMMON FEMORAL ARTERY WITH HEAVY CALCIFICATION AND HEAVE TORTUOSITY. THE 6X60MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER A RUPTURE OCCURRED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A SAME SIZE ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824562 ↗
• MalfunctionOct 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE ON AN UNSPECIFIED DATE, THE 6.00X60MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) RUPTURED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER BDC WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656710 ↗
• MalfunctionJul 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) TO DISTAL POPLITEAL. THE 3.0X60MM ARMADA 18 AND 4.0X60MM ARMADA 14 BALLOON DILATATION CATHETER BOTH RUPTURED. THE ARMADA 14 RUPTURED AT 11 ATMOSPHERES; HOWEVER, BOTH BALLOONS WERE NOTED TO RUPTURE BEFORE REACHING 14 ATMOSPHERES. ANOTHER UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15095275 ↗
• MalfunctionJun 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS DELIVERED WITH EASE BUT UPON INFLATION RUPTURED AT 7 ATMOSPHERES. THE BALLOON WAS REMOVED WITHOUT ISSUE. ANOTHER SAME SIZE ARMADA 18 WAS USED AND A SUPERA STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND 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 10201783 ↗
• MalfunctionApr 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. ATHERECTOMY WAS PERFORMED. AN ARMADA 18 6.0X60MM BALLOON WAS INFLATED AND RUPTURED AT 6 ATMOSPHERES. ANOTHER 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 8531984 ↗
• MalfunctionJan 23, 2017Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. NO ISSUES WERE NOTED DURING PREPARATION OF THE 6.0MM/60MM ARMADA 18 BALLOON CATHETER. THE BALLOON CATHETER CROSSED THE LESION WITH EASE. DURING ATTEMPTED INFLATION OF THE BALLOON A DROP IN PRESSURE WAS NOTED. UPON INVESTIGATION IT WAS OBSERVED THAT THE HUB WAS LEAKING CAUSING THE LOSS OF PRESSURE. THE BALLOON CATHETER WAS REMOVED WITHOUT ISSUE FROM THE PATIENT. THE PROCEDURE WAS ENDED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6270814 ↗