Armada 1013465-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648207914), received between Sep 22, 2017 and Feb 27, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LOWER EXTREMITY ARTERY. THE 3.0X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 6 ATMOSPHERES (ATMS). 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 18792828 ↗
• MalfunctionSep 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY. TWO BALLOONS (3X120MM ARMADA 14 AND 3X150MM ARMADA 18) WERE USED AND BOTH RUPTURED WHEN THEY WERE INFLATED ONCE AT 14 ATMOSPHERES. ANOTHER SMALLER SIZED BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12476838 ↗
• MalfunctionFeb 19, 2020Leak/Splash; Product Quality Problem; Leak/Splash; Product Quality Problem

  IT WAS REPORTED THAT THE ARMADA 18 WAS SUCCESSFULLY INFLATED AT 8 ATMOSPHERES IN THE POSTERIOR TIBIAL ARTERY AND ANOTHER DISTAL ARTERY WITHOUT INCIDENT. THE ARMADA 18 WAS REMOVED FROM THE PATIENT AND THE CASE CONTINUED. THE PHYSICIAN WAS INTENDING TO USE THE ARMADA 18 A THIRD TIME IN THE PATIENT WHEN SHE NOTICED THAT THE BALLOON DID NOT APPEAR TO HAVE RE-WRAPPED CORRECTLY. IT WAS DECIDED TO USE AN ARMADA 35 TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A LEAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9728251 ↗
• MalfunctionFeb 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNSPECIFIED CORONARY ARTERY. THE 3.0 X 150 MM ARMADA 18 BALLOON CATHETER WAS ADVANCED IN THE VESSEL; HOWEVER, DURING THE 3RD INFLATION IT WAS NOT POSSIBLE TO KEEP THE PRESSURE STABLE DUE TO A LEAK AT THE HUB. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9717656 ↗
• MalfunctionSep 22, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED PERONEAL ARTERY. A 3.0 X 150 MM ARMADA 18 BALLOON CATHETER RUPTURED DURING THE FIRST INFLATION BELOW NOMINAL PRESSURE. A SECOND 3.0 X 150 MM ARMADA 18 BALLOON CATHETER ALSO RUPTURED DURING THE FIRST INFLATION BELOW NOMINAL PRESSURE. BOTH DEVICES WERE PREPPED PER THE INSTRUCTIONS FOR USE AND THERE WAS NO RESISTANCE ADVANCING THE DEVICES. A NON-ABBOTT .035 BALLOON CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6888273 ↗
• MalfunctionSep 22, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED PERONEAL ARTERY. A 3.0 X 150 MM ARMADA 18 BALLOON CATHETER RUPTURED DURING THE FIRST INFLATION BELOW NOMINAL PRESSURE. A SECOND 3.0 X 150 MM ARMADA 18 BALLOON CATHETER ALSO RUPTURED DURING THE FIRST INFLATION BELOW NOMINAL PRESSURE. BOTH DEVICES WERE PREPPED PER THE INSTRUCTIONS FOR USE AND THERE WAS NO RESISTANCE ADVANCING THE DEVICES. A NON-ABBOTT .035 BALLOON CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6888265 ↗