Armada A1030-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648155826), received between Feb 22, 2018 and Apr 28, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Expiration Issue” (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. 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.

• MalfunctionApr 28, 2025Leak/Splash; Difficult to Remove; Difficult to Advance; Leak/Splash; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. NO INTRODUCER SHEATH WAS UTILIZED TO ACCESS THE ARTERY. THE 3.0X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON WAS INFLATED TWICE AND THEN REMOVED; HOWEVER, DIFFICULTY WAS AGAIN MET AT THE ACCESS SITE. ONCE REMOVED FROM THE ANATOMY, THE PHYSICIAN TESTED THE DEVICE AND A LEAK WAS NOTED IN THE SHAFT. THE PROCEDURE WAS COMPLETED TWO ADDITIONAL ARMADA DEVICES. 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 21918704 ↗
• MalfunctionJun 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS ANTERIOR TIBIAL. THE 3.0X120MM (90CM) ARMADA 14 BALLOON RUPTURED AT 10ATM ON THE FIRST INFLATION. THE DEVICE WAS REPLACED WITH A NEW ARMADA 14 3.0X120MM (150CM). THE BALLOON WAS INFLATED TO 10 ATM THEN THE BALLOON RUPTURED ON THE SECOND INFLATION AT 12ATM. NO ADDITIONAL BALLOONING WAS DONE. THE VESSEL WAS TREATED WITH A LASER. 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 10133258 ↗
• MalfunctionMar 9, 2018Difficult To Position

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT AN UN-SPECIFIED LESION. THE 3.0 X 120 MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) RUPTURED DURING USE. A NEW ARMADA BDC WAS USED TO 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 7329279 ↗
• MalfunctionFeb 22, 2018Device Expiration Issue; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED PERIPHERAL ARTERY. A 3.0 X 120 MM ARMADA 14 BALLOON DILATATION CATHETER WAS USED (BDC); HOWEVER, THE DEVICE WAS USED PAST ITS EXPIRATION DATE BECAUSE IT WAS USED ON (B)(6) 2018 AND THE USE BY DATE WAS ON 12/31/2017. 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 7290482 ↗