Armada 1013468-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08717648208249), received between Sep 8, 2016 and Jan 2, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Failure to Fold; Difficult to Insert; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. AFTER SUCCESSFUL USE OF THE 5.0X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC), THE ARMADA 18 BDC WAS USED A SECOND TIME; HOWEVER, THE BALLOON FAILED TO FOLD PROPERLY AND COULD NOT RE-ENTER THE INTRODUCER SHEATH. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946884 ↗
• MalfunctionMay 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 100% STENOSED LESION IN LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. FOR POST DILATATION A 5X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS USED; HOWEVER, THE BALLOON RUPTURED AFTER 3 INFLATIONS AT 8 ATMOSPHERES. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. ANOTHER SAME SIZE ARMADA 18 BDC WAS THEN USED TO CONTINUE POST DILATION; HOWEVER, DURING THE FIRST INFLATION THE SECOND ARMADA BALLOON WAS NOTED TO HAVE A LEAK OF CONTRAST AT THE BASE OF THE INFLATION PORT. DURING REMOVAL, THE SECOND BDC BECAME STUCK WITH THE STENT THAT HAD BEEN IMPLANTED AND COULD NOT BE REMOVED FROM THE PATIENT. THEREFORE, CUT-DOWN SURGERY WAS PERFORMED TO REMOVE THE BDC. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325954 ↗
• 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 15676054 ↗
• MalfunctionAug 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY WITH MODERATE CALCIFICATION. THE 5.00X200MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND DURING INFLATION TO NOMINAL PRESSURE THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT ISSUE FROM THE PATIENT. THEN, A 6.00X80MM ARMADA BDC WAS ADVANCED TO THE TARGET LESION AND DURING INFLATION FOR 1 MINUTE, THE BALLOON RUPTURED BEFORE REACHING NOMINAL PRESSURE. THE DEVICE WAS REMOVED, WITHOUT ISSUE, FROM PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. TWO ABBOTT BALLOONS WERE USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15168551 ↗
• MalfunctionJul 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION. THE 5X200 ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION AND INFLATED ONCE TO 9 ATMOSPHERES; HOWEVER, THE BALLOON RUPTURED. THERE WERE NO ADVERSE PATIENT EFFECTS. HEPARIN WAS PROVIDED PER STANDARD PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008587 ↗
• InjuryJun 29, 2022Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.0X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 12 ATMOSPHERES. DURING REMOVAL RESISTANCE WAS NOTED WITH THE GUIDE CATHETER AND THE BALLOON SEPARATED. THE SEPARATED PORTION WAS REMOVED VIA SNARE. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852590 ↗
• MalfunctionDec 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE RIGHT MID SUPERFICIAL FEMORAL ARTERY, MODERATELY CALCIFIED LESION. AN ARMADA DILATATION CATHETER ADVANCED WITHOUT ISSUE AND THE FIRST INFLATION WAS PERFORMED FOR ABOUT 30 SECONDS AT 6 ATMOSPHERES WHEN THE BALLOON BURST. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026158 ↗
• MalfunctionApr 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY/POPLITEAL ARTERY. THE 5.0X200MM ARMADA 18 BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED SHORTER LENGTH BALLOON DILATATION CATHETER. 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 9982950 ↗
• MalfunctionFeb 18, 2020Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A COMMAND 18 GUIDE WIRE WAS ADVANCED WITH A 5X200 ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WITHOUT RESISTANCE. THE ARMADA WAS INFLATED, AND THE BALLOON FOLDS WERE BUNCHED AFTER DEFLATION. THE GUIDE WIRE AND PTA FACED RESISTANCE WITH EACH OTHER DURING REMOVAL, SO THE DEVICES WERE REMOVED TOGETHER. THE POLYMER OF THE COMMAND GUIDE WIRE WAS PEELED. IT WAS CONFIRMED THAT NO PORTION OF THE DEVICES REMAIN IN THE ANATOMY. AN UNSPECIFIED COMMAND GUIDE WIRE AND UNSPECIFIED ARMADA PTA 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 9720202 ↗
• MalfunctionDec 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY THAT WAS MODERATELY CALCIFIED. THE ARMADA 18 BALLOON WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE, BUT RUPTURED DURING THE FIRST INFLATION AT 14 ATMOSPHERES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9419700 ↗
• MalfunctionMay 9, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200 MM ARMADA BALLOON CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION. HOWEVER, DURING AN ATTEMPT TO INFLATE THE BALLOON, THE BALLOON DID NOT HOLD PRESSURE DUE TO A LEAK WAS OBSERVED AT THE SIDEARM. SALINE AND CONTRAST MIXTURE WAS LEAKING FROM THE SIDEARM PORT AT THE CONNECTION POINT. THE BDC WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER UNSPECIFIED BDC. 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 8596780 ↗
• MalfunctionMar 5, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED TO THE LESION WITH NO RESISTANCE. ON THE INITIAL INFLATION OF THE BALLOON OF THE PTA BALLOON CATHETER TO AN UNKNOWN PRESSURE, THE BALLOON ONLY PARTIALLY INFLATED AND CONTRAST / STAINING WAS NOTED TO LEAK OUT BETWEEN THE SHAFT AND HUB. THE PTA BALLOON CATHETER WAS SIMPLY REMOVED AND REPLACED WITH A NEW UNSPECIFIED ARMADA PTA BALLOON CATHETER TO SUCCESSFULLY CONTINUE 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 8391223 ↗
• MalfunctionSep 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.0 X 200 MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED TWICE, BUT RUPTURED AT NOMINAL PRESSURE. THE BDC WAS REMOVED WITHOUT ISSUE AND A DIFFERENT BALLOON USED IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7898071 ↗
• MalfunctionMar 14, 2018Deflation Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE 5MMX200MMX150CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE DEVICE WAS INFLATED ONCE TO 10 ATMOSPHERES WITHOUT ISSUE. NEGATIVE PRESSURE WAS HELD AND BALLOON DEFLATION WAS SLOW. IT TOOK APPROXIMATELY 25-30 SECONDS, FOR THE BALLOON TO FULLY DEFLATE. THE BDC WAS WITHDRAWN WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7338404 ↗
• MalfunctionJan 25, 2018Material Rupture; Pressure Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED MID SUPERFICIAL FEMORAL ARTERY. A 5.0 X 200 MM ARMADA 18 BALLOON CATHETER WAS ADVANCED TO THE LESION AND THE BALLOON WAS INFLATED TWO TIMES TO RATED BURST PRESSURE. DURING THE THIRD INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERES. ANOTHER ARMADA 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 Known Impact Or Consequence To Patient

  MAUDE report 7220541 ↗
• MalfunctionApr 10, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MODERATELY TORTUOUS, MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 5.0 X 200 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS SELECTED FOR THE PROCEDURE. THE PTA CATHETER WAS ADVANCED WITH NO RESISTANCE TO THE LESION, BUT UPON INFLATION OF THE BALLOON, CONTRAST WAS OBSERVED COMING FROM THE BALLOON. DESPITE THE LEAK THE LESION WAS SUCCESSFULLY DILATED AND THE PTA CATHETER WAS REMOVED FROM THE ANATOMY. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6476012 ↗
• MalfunctionSep 8, 2016Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH MODERATE CALCIFICATION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE ARMADA 18 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION WITH NO RESISTANCE NOTED. DURING INFLATION OF THE ARMADA 18, A PINHOLE WAS NOTED IN THE BALLOON AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY ISSUES AND A NEW ARMADA 18 WAS USED IN THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5937211 ↗