Armada B1030-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648154485), received between Jan 8, 2018 and Jun 3, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionJun 3, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.0X20MM ARMADA 35 BALLOON DILATATION CATHETER, AIR ASPIRATION COULD NOT BE COMPLETED. THE DEVICE WAS NOT USED. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14595436 ↗
• MalfunctionNov 2, 2018Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3X20 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS SUCCESSFULLY USED IN A PROCEDURE TO TREAT A RENAL ARTERY. AFTER THE PROCEDURE IT WAS DISCOVERED THAT THE BALLOON WAS EXPIRED. 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 8034222 ↗
• MalfunctionJan 8, 2018Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS (AV) FISTULA. IT WAS NOTED THAT A 3X20MM ARMADA 35 WAS LEAKING AT THE HUB DURING THE FIRST ATTEMPTED INFLATION. ANOTHER ARMDA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7172188 ↗