Armada B2090-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648155475), received between Sep 15, 2020 and Mar 20, 2025 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2025Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE COMMON FEMORAL ARTERY. AFTER A STENT WAS DEPLOYED, A 9X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR POST-DILATATION; HOWEVER, THE BALLOON WAS NOTED TO BURST AT 8ATMS AND DURING WITHDRAWAL RESISTANCE WAS FELT WITH THE 6F INTRODUCER SHEATH AFTER THE BDC WAS FULLY DEFLATED, SUBSEQUENTLY CAUSING THE BALLOON AND TIP OF THE BDC TO BE TORN OFF FROM THE DELIVERY SYSTEM. ARTERIOTOMY WAS PERFORMED AND THE BALLOON MATERIAL AND ITS TIP WERE REMOVED, AND THE ARTERY WAS SUTURED WITH A VASCULAR SUTURE COMPLETING THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21658082 ↗
• MalfunctionJul 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED ILIAC LESION. THE 9.0X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET VESSEL AND PRESSURIZED WITH A SYRINGE WHEN THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ARMADA 35. 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 19700024 ↗
• MalfunctionAug 5, 2021Inflation Problem; Product Quality Problem; Difficult to Remove; Material Separation; Inflation Problem; Product Quality Problem; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE INITIALLY FILED REPORT THE FOLLOWING INFORMATION WAS PROVIDED: THE PROCEDURE WAS TO TREAT THE RIGHT ILIAC ARTERY. THE BALLOON DID NOT COMPLETELY INFLATE. RESISTANCE WAS NOTED DURING REMOVAL AND SHAFT DAMAGE OCCURRED. IT WAS CONFIRMED THAT NO SEPARATION OCCURRED. THE ARMADA 35 WAS SIMPLY PULLED TO RETRIEVE THE BALLOON FROM THE ANATOMY. 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 12281905 ↗
• MalfunctionSep 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED AND 70% STENOSED ILIAC ARTERY. AN ARMADA 35 9X40 BALLOON CATHETER WAS INSERTED AND THE BALLOON WAS ATTEMPTED TO BE INFLATED. HOWEVER, WHEN THE BALLOON WAS INFLATED TO 6 ATMOSPHERES, IT WAS NOTICED THAT IT AS UNABLE TO REACH NOMINAL PRESSURE DUE TO A LEAK OF THE CONTRAST MEDIUM. THE BALLOON WAS ABLE TO BE REMOVED WITHOUT ISSUES. 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 10536046 ↗