Armada B2140-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648155611), received between Aug 17, 2022 and Sep 24, 2022 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 70% STENOSED LESION IN THE LEFT SUPERIOR FEMORAL ARTERY (SFA). A 14X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED ONE TIME TO 8 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED, AND A NEW BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15477208 ↗
• MalfunctionAug 17, 2022Material Rupture; Material Rupture

  USER FACILITY MEDWATCH REPORT (4500440000-2022-8030) RECEIVED STATING: THE SURGEON PERFORMED ANOTHER INTRAVASCULAR ULTRASOUND, WHICH SHOWED SOME EVIDENCE OF INCOMPLETE EXPANSION AT THE MOST PROXIMAL ASPECT OF THE ABRE STENT AT THE INFERIOR VENA CAVA NOTCH AND SOME LEVEL OF LUMINAL LOSS. TO ADDRESS THIS PROBLEM, THE SURGEON THEN ADVANCED WITH THE 12 ARMADA BALLOONS FROM BOTH FEMORAL VEIN ACCESS AND BALLOONED THE MOST PROXIMAL ASPECT USING THE KISSING BALLOON TECHNIQUE TO GAIN A GOOD WALL APPOSITION AND EXPANSION OF THE ABRE STENT AT ITS PROXIMAL EXTENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : BILATERAL ILIOCAVAL RECONSTRUCTION. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) : DEVICE FAILED (E.G. BROKE, COULDN'T GET IT WORK OR STOPPED WORKING). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15244355 ↗