Armada B2120-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648155574), received between Feb 28, 2018 and Jan 13, 2025 — classified as 3 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 18, 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.

• MalfunctionJan 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED DURING THE PROCEDURAL PREPARATION OF A 12X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) A LEAK WAS NOTED WHEN THE DEVICE WAS PURGED WITH SALINE. A NEW SAME SIZED ARMADA 35 BDC WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144183 ↗
• MalfunctionDec 16, 2020Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MODERATELY CALCIFIED ILIAC ARTERY THAT WAS 70% STENOSED. A 12X80MM ARMADA 35 BALLOON WAS ADVANCED TO THE LESION AND WHEN PRESSURIZED AT 8 ATMOSPHERES THE ARMADA WAS NOTED AS HAVING FAILED TO INFLATE AND RUPTURED. ANOTHER DEVICE 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 11019884 ↗
• MalfunctionFeb 28, 2018Detachment Of Device Component; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ILIAC ARTERY. A 12 X 80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) INFLATED ONE TIME AT 10 ATMOSPHERES AND RUPTURED. NO REPORTED RESISTANCE DURING ADVANCEMENT OR REMOVAL. WHEN DEVICE WAS REMOVED THE SHAFT OF THE BALLOON APPEARED SEPARATED SINCE THE BALLOON WAS LOOPED ON THE GUIDE WIRE. THE DISTAL SHAFT OF THE BDC SEPARATED INTO TWO PIECES. THE BALLOON WAS ALSO NOTED TO BE SEPARATED FROM THE CATHETER AND THE BALLOON MARKERS WERE ALSO DETACHED FROM THE INNER MEMBER. THE DEVICE WAS SIMPLY WITHDRAWN, AS THE ENTIRE DEVICE CAME OUT WITH THE WIRE. THE PROCEDURE CONTINUED. ANGIOJET THROMBECTOMY WAS PERFORMED, WHICH WAS UNRELATED TO THE USE OF THE DEVICE. ANOTHER ARMADA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7304708 ↗