Armada A2020-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648155949), received between Aug 26, 2022 and Aug 26, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 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 LESION IN THE POPLITEAL ARTERY OF THE TIBIOPERONEAL (TP) TRUNK. THE 2.0X20MM ARMADA BALLOON CATHETER HAD NO RESISTANCE DURING ADVANCEMENT AND WAS CONNECTED TO AN INDEFLATOR. WHEN PRESSURIZED WITH 2-3 ATMOSPHERES (ATMS), THE BALLOON DID NOT HOLD PRESSURE. THERE WAS NO RESISTANCE DURING REMOVAL. THE ARMADA WAS SOAKED, HOWEVER, IT WAS NOT PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. ANOTHER SAME SIZE ARMADA WAS USED WITH THE SAME INDEFLATOR TO COMPLETE THE PROCEDURE. THE PATIENT WAS HEPARINIZED. 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 15303512 ↗