Armada A2040-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648156144), received between Apr 30, 2019 and Jan 16, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED LESION IN THE POPLITEAL ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. AFTER A COMMAND ES GUIDE WIRE (GW) CROSSED THE TARGET LESION, THE 4X60MM ARMADA 14 BALLOON DILATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO NOMINAL PRESSURE; HOWEVER, THE BALLOON COULD NOT BE COMPLETELY INFLATED. THE HUB OF THE BDC WAS THEN NOTED TO HAVE LEAKAGE; THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A 4X80MM ARMADA BALLOON 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 21170920 ↗
• MalfunctionJun 8, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION OF AND BEFORE USE IN THE PATIENT, WHEN NEGATIVE PRESSURE WAS PULLED, THERE WAS A LEAK OBSERVED IN THE BALLOON [TEAR/HOLE IN BALLOON] ON A 9X20MM ARMADA 35 BALLOON CATHETER AN A 4.0X60MM ARMADA 14 BALLOON CATHETER. THE SAME ISSUE OCCURRED WITH BOTH BALLOONS. ANOTHER ARMADA WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17092162 ↗
• MalfunctionJul 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) TO DISTAL POPLITEAL. THE 3.0X60MM ARMADA 18 AND 4.0X60MM ARMADA 14 BALLOON DILATATION CATHETER BOTH RUPTURED. THE ARMADA 14 RUPTURED AT 11 ATMOSPHERES; HOWEVER, BOTH BALLOONS WERE NOTED TO RUPTURE BEFORE REACHING 14 ATMOSPHERES. ANOTHER UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15095354 ↗
• MalfunctionJun 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT TIBIAL ARTERY. A 4X200MM ARMADA 18 BALLOON WAS ADVANCED TO THE LESION AND INFLATED ONCE AT 18 ATMOSPHERES (ATMS) WHEN IT RUPTURED. ANOTHER 4X60MM ARMADA 14 BALLOON WAS THEN USED BUT WHEN INFLATED ONCE IT RUPTURED AT ABOUT 4 ATMS. ANOTHER ARMADA 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 12050855 ↗
• MalfunctionJun 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, NON-TORTUOUS, 70% STENOSED SUPERFICIAL FEMORAL ARTERY. A 6X200MM, 3X80MM, & 5.5X200MM ARMADA 18 AS WELL AS A 3X40MM & 4X60MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETERS (PTA) WERE ALL ADVANCED, AND THE BALLOONS RUPTURED AT 14 ATMOSPHERES IN THAT ORDER. A NON-ABBOTT BALLOON AND TWO UNSPECIFIED STENTS WERE 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 Consequences Or Impact To Patient

  MAUDE report 10153896 ↗
• MalfunctionJul 30, 2019Deflation Problem; Material Separation; Deflation Problem; Material Separation

  IT WAS REPORTED THAT THIS WAS A PROCEDURE PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY. THE ARMADA 14 DILATATION CATHETER WAS INFLATED WITHOUT ISSUE; HOWEVER, THE BALLOON ONLY PARTIALLY DEFLATED, BUT WAS ABLE TO BE PULLED BACK INTO THE SHEATH AND REMOVED WITHOUT ISSUE. THE PATIENT WAS OBSERVED FOR APPROXIMATELY 2 HOURS POST PROCEDURE AND NO PATIENT INJURY WAS NOTED. A SECOND ARMADA 14 WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8843506 ↗
• MalfunctionApr 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED POPLITEAL ARTERY. A 4.0 X 60 MM ARMADA 14 BALLOON CATHETER WAS USED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES DUE TO THE CALCIFIED LESION. AN UNSPECIFIED ARMADA 35 BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8566189 ↗