Armada B2140-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648155598), received between Oct 30, 2019 and Sep 3, 2025 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionSep 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON FEMORAL VEIN. THE 14X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON RUPTURED. 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 22950930 ↗
• InjuryJul 25, 2025Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT POPLITEAL ARTERY. FOR POST-DILATATION, THE 14X40MM ARMADA BALLOON DILATION CATHETER WAS USED WITH AN 8 FR SHEATH. THE BALLOON WAS INFLATED TWO TIMES; HOWEVER, THE BALLOON RUPTURED AT 4 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND AND RESISTANCE WAS NOTED WITH THE SHEATH AND PART OF THE BALLOON WAS NOTED TO HAVE SEPARATED AND REMAINED IN THE PATIENT. CUTDOWN SURGERY WAS PERFORMED TO REMOVE THE SEPARATED PORTION OF THE BALLOON. AN ADDITIONAL 45 MINUTES WERE REQUIRED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609529 ↗
• MalfunctionOct 30, 2019Break; Off-Label Use; Improper or Incorrect Procedure or Method; Break; Off-Label Use; Improper or Incorrect Procedure or Method

  A USER FACILITY MEDWATCH REPORT WAS RECEIVED STATING: BALLOON WAS PREPPED AND USED TO PRE DILATE AN AORTIC VALVE. THE BALLOON DID NOT RUPTURE. WHEN BALLOON WAS REMOVED A SMALL PLASTIC PIECE WAS HANGING. THE DOCTOR IS NOT SURE IF IT HAPPENED DURING REMOVAL FROM THE SHEATH/BODY. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THAT THERE WAS FOREIGN MATERIAL BONDED TO THE PROXIMAL SEAL AND THAT IT WAS LIFTED AWAY FROM THE OUTER MEMBER. IT IS MOST LIKELY THAT THE ACCOUNT WAS REFERRING TO THIS FOREIGN MATERIAL WHEN REPORTING THAT THE BALLOON WAS PEELED OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257435 ↗