Armada A2040-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648156137), received between Nov 13, 2019 and Jun 10, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 60% STENOSED LESION IN THE COMMON ILIAC ARTERY WITH MODERATE CALCIFICATION. THE 4X40MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, THE BALLOON BURST DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). ANOTHER ARMADA BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462275 ↗
• MalfunctionFeb 7, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 4X40MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WHEN PULLING NEGATIVE THE BDC CONTINUED TO PULL AIR. THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664517 ↗
• MalfunctionApr 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE POPLITEAL ARTERY. A 4.0X40MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS PREPARED FOR USE, ADVANCED AND POSITIONED TO PRE-DILATE THE LESION. THE BALLOON WAS INFLATED TO NOMINAL PRESSURE, RUPTURED ON THE FIRST INFLATION. ANOTHER ARMADA PTA 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: Insufficient Information

  MAUDE report 11606566 ↗
• MalfunctionJan 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT UPPER ARM LOOP AXILLARY-AXILLARY AV GRAFT WITH POOR FUNCTION AND STENOSIS. THE 4.0X40MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED AND RUPTURED AT AN UNKNOWN PRESSURE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT, BUT THE PHYSICIAN THOUGHT THAT THE STENOSIS HAD A JAGGED EDGE, WHICH MIGHT HAVE CAUSED THE BALLOON TO RUPTURE. A NON-ABBOTT NON COMPLIANT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11152333 ↗
• MalfunctionNov 13, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION, THERE WAS A PINHOLE IN THE BALLOON OF A 4.0 X 40 MM ARMADA 14 BALLOON CATHETER AS THE DEVICE FAILED TO PRESSURIZE WHEN PULLING NEGATIVE AIR. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER 4.0 X 40 MM ARMADA 14 BALLOON CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9317382 ↗