Armada B2080-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648155444), received between Oct 1, 2018 and Jul 8, 2024 — classified as 4 injuries, 4 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.

• MalfunctionJul 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE ILIAC ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 8X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH A SUPRA CORE GUIDE WIRE; HOWEVER, WHEN THE BALLOON WAS INFLATED ONCE TO NOMINAL PRESSURE A RUPTURE OCCURRED. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. AN 8X40MM ARMADA BALLOON WAS USED IN THE PROCEDURE, FOLLOWED BY IMPLANTATION OF AN 8X80MM ABSOLUTE PRO STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697279 ↗
• MalfunctionJul 3, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ILIAC ARTERY. THE 8X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, THE BALLOON FAILED TO INFLATE. THEREFORE, THE THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER ARMADA 35 BALLOON WAS USED TO CONTINUE THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND A LEAK WAS NOTED AT THE INFLATION PORT OF THE HUB OF THE BDC. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670888 ↗
• MalfunctionMar 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ILIAC VEIN WITHOUT CALCIFICATION AND WITHOUT TORTUOSITY. THE 8.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND ADVANCED WITHOUT RESISTANCE; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT NOMINAL PRESSURE OF 6 ATMOSPHERES (ATMS). A LARGER SIZE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 18874833 ↗
• InjuryMar 4, 2024Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE STEALTH ATHERECTOMY DEVICE WAS USED, HOWEVER THE DEVICE GOT STUCK DURING REMOVAL. THE DEVICE WAS REMOVED INTACT AND WAS REPLACED WITH A NEW STEALTH DEVICE. THE SECOND STEALTH DEVICE ALSO GOT STUCK DURING REMOVAL. THE DEVICE WAS REMOVED INTACT. THE 8.0X60MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE AND CONTRAST MIX WAS 75/25. THE BDC WAS ADVANCED AND RESISTANCE WAS FELT DURING ADVANCEMENT DUE TO CALCIFICATION. THE BALLOON CATHETER WAS PUSHED A LITTLE HARDER AND THE CATHETER CROSSED. THE BALLOON WAS INFLATED TWICE TO 6ATM FOR APPROXIMATELY ONE MINUTE AND NEGATIVE WAS HELD FOR 30 SECONDS, BUT THE BALLOON ONLY PARTIALLY DEFLATED. THE BDC WAS REMOVED WITH SOME RESISTANCE AND LIGHT FORCE WAS APPLIED; HOWEVER, THE BALLOON SEPARATED IN THE ANATOMY. THE PATIENT WAS BLEEDING, A PERFORATION OCCURRED. THE PATIENT WENT FOR OPEN SURGERY FOR REMOVAL OF THE BALLOON AND TO TREAT THE PERFORATION. THE SEPARATED PORTION OF THE BALLOON WAS REMOVED FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELAE AND T

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 18827172 ↗
• InjurySep 27, 2022Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 90% LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. ATHERECTOMY WAS PERFORMED AND AN 8X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED ONE TIME; HOWEVER, IT RUPTURED AT BURST PRESSURE. SUBSEQUENTLY, AN 8X60MM ARMADA 35 BDC WAS ADVANCED AND INFLATED ONE TIME TO NOMINAL PRESSURE WHEN THE BALLOON RUPTURED AND SEPARATED FROM THE CATHETER IN THE RIGHT EXTERNAL ILIAC ARTERY. ONE HOUR WAS SPENT TRYING TO SNARE OUT THE SEPARATED SEGMENT, HOWEVER IT WAS UNSUCCESSFUL. AN 8.X5CM NON-ABBOTT COVERED STENT WAS IMPLANTED TO EMBED THE SEPARATED SEGMENT IN THE ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15491867 ↗
• InjuryJul 26, 2019Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ARTERIOVENOUS FISTULA. AN 8X60MM ARMADA 35 BALLOON CATHETER RUPTURED TRANSVERSELY DURING THE SECOND INFLATION AT 14 ATMOSPHERES AND RUPTURED THE FISTULA. THE FISTULA HAD TO BE OPENED AND REPAIRED SURGICALLY. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 8834107 ↗
• InjuryApr 30, 2019Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS IN THE COMMON ILIAC AND EXTERNAL ILIAC JUST PAST THE INTERNAL ILIAC BIFURCATION WITH MODERATE TO SEVERE CALCIFICATION AND 50-70% STENOSIS. NO RESISTANCE WAS NOTED DURING ADVANCEMENT AND BALLOON ANGIOPLASTY WAS ATTEMPTED WITH THE ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. THE BALLOON WAS INFLATED ONCE TO 10 ATMOSPHERES AND RUPTURED. WHEN THE DEVICE WAS ATTEMPTED TO BE REMOVED NEGATIVE PRESSURE WAS HELD, AND THE BALLOON WAS STUCK IN THE ANATOMY. THE CATHETER WAS ABLE TO BE REMOVED FROM THE SHEATH WITH FORCE; HOWEVER, THE BALLOON CAME OFF THE CATHETER AND REMAINED IN THE VESSEL. A STENT WAS USED TO EMBED THE BALLOON WHERE IT WAS LOCATED. THE PATIENT IS STABLE. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8566276 ↗
• MalfunctionOct 1, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH NO TORTUOSITY AND MODERATE CALCIFICATION. AN 8.0 X 60 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED TO THE LESION WITH NO RESISTANCE; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION TO NOMINAL PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ADDITIONAL ARMADA 35 PTA BALLOON CATHETER. 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 7923440 ↗