Armada 1013468-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648208218), received between Mar 9, 2018 and Nov 18, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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.

• MalfunctionNov 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT IN-STENT RESTENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.0X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, WHEN INFLATED, THE BALLOON RUPTURED AT 5 ATMOSPHERES (ATM). THE BDC WAS REMOVED AND A 5.0X120MM ARMADA 18 WAS ADVANCED HOWEVER THE SAME ISSUE OCCURRED. A THIRD DEVICE, A 5.0X40MM ARMADA 35 WAS USED; HOWEVER AGAIN THE BALLOON RUPTURED AT 5 ATM. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DEVICE. 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 23580884 ↗
• MalfunctionAug 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY. THE 5.0X120MM, 5.0X150MM ARMADA 35 BALLOON DILATATION CATHETERS RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATM). A 7.0X100MM ABSOLUTE PRO STENT WAS THEN DEPLOYED IN THE TARGET LESION. A 6.0X40MM ARMADA 35 WAS USED TO POST DILATE THE STENT HOWEVER ALSO RUPTURED DURING THE FIRST INFLATION AT 10 ATM. 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 22883862 ↗
• MalfunctionOct 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION AND NO TORTUOSITY AND ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE 5.0X120MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) ADVANCED WITHOUT ANY RESISTANCE NOTED AND RUPTURED AT NOMINAL PRESSURE DURING THE FIRST INFLATION. ANOTHER 5.0X200MM ARMADA 18 (BDC) WAS THEN ADVANCE WITHOUT RESISTANCE NOTED AS WELL, HOWEVER, RUPTURED DURING THE FIRST INFLATION AT 14 ATMOSPHERES (ATMS). THE BALLOON PRESSURE WAS HELD FOR ABOUT 2 MINUTES AND AT ABOUT 1.5 MINUTES IT RUPTURED. THE 2.0X200MM ARMADA 14 BDC WAD ADVANCED TO THE ANTERIOR TIBIAL ARTERY WITHOUT RESISTANCE BUT ALSO RUPTURED AT NOMINAL PRESSURE DURING THE FIRST INFLATION. AGAIN, THE PRESSURE WAS HELD FOR 2 MINUTES BUT THIS TIME RUPTURED AFTER ABOUT A MINUTE. ALL DEVICES WERE PREPARED PER INSTRUCTIONS FOR USE (IFU). NON-ABBOTT BALLOONS WERE USED TO COMPLETE THE PROCEDURE FOR THE SFA AND THE ANTERIOR TIBIAL ARTERY. 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 15675883 ↗
• MalfunctionApr 14, 2021Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN ARMADA 18 AND AN ARMADA 35 BALLOON WITH PREPARED OUTSIDE THE ANATOMY BUT WERE NOT SOAKED IN SALINE PRIOR TO USE, ONLY WIPED DOWN. THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL POPLITEAL ARTERY THAT HAD SIGNIFICANT ECCENTRIC CALCIUM AND WAS 90% STENOSED. AFTER ADVANCEMENT TO THE LESION WITHOUT ISSUE, THE ARMADA 18 BALLOON RUPTURED DURING THE FIRST INFLATION AT 16 ATMOSPHERES (ATM). AFTER ADVANCEMENT TO THE LESION WITHOUT ISSUE, THE ARMADA 35 BALLOON RUPTURED DURING THE FIRST INFLATION AT 14 ATM. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AN ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668255 ↗
• MalfunctionMar 9, 2018Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON FEMORAL ARTERY. THE 5.0X120MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON TWICE, HOWEVER THE BALLOON ONLY HALF INFLATED AND WOULD NOT HOLD PRESSURE. 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 7328819 ↗