Armada 1013470-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648208430), received between May 29, 2018 and Mar 17, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Material Rupture

  IT WAS REPORTED THAT THE ARMADA 18 BALLOON WAS FLUSHED PRIOR TO USE; HOWEVER, IT RUPTURED DURING THE PROCEDURE AT 10 ATMOSPHERES WITH THE FIRST INFLATION IN THE SUPERFICIAL FEMORAL ARTERY. THE ARMADA 18 DEVICE WAS REMOVED INTACT. A 6.0X150MM NON-ABBOTT DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617779 ↗
• MalfunctionDec 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY. AN ARMADA 18 WAS INSERTED BUT RUPTURED AT 10ATM. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER ARMADA 18. 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 23912805 ↗
• MalfunctionAug 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 6.0X120MM ARMADA 18 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 22700346 ↗
• MalfunctionMay 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT POPLITEAL ARTERY. AFTER THE LESION WAS PRE-TREATED WITH LASER ATHERECTOMY AND ANGIOPLASTY, A 6X120MM ARMADA 18 BALLOON DILATATION CATHETER (BDC), WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 8ATM. THEREFORE, THE BDC WAS REMOVED AND THE PROCEDURE WAS CONTINUED WITH ANOTHER SAME SIZED ARMADA 18 BDC. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021251 ↗
• MalfunctionAug 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT SUPERIOR FEMORAL ARTERY. THE 6.0X120MM ARMADA 18 BALLOON RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. ANOTHER ARMADA BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907136 ↗
• MalfunctionDec 11, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6.0MMX120MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS FLUSHED WITH SALINE; HOWEVER, SALINE WAS NOTED TO BE COMING OUT OF THE BALLOON. THE BALLOON SEEM TO HAVE SMALL PIN HOLES. THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE ARMADA 18 BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301544 ↗
• MalfunctionJun 2, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID SUPERFICIAL FEMORAL ARTERY THAT WAS MODERATELY CALCIFIED. THE PROXIMAL MARKER WAS OFF (TOO FAR IN) AND DID NOT ALIGN WITH THE BALLOON (2-3MM OFF) BUT THE DEVICE WAS SUCCESSFULLY USED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580801 ↗
• MalfunctionMar 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND A LESION IN THE MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. THE 6.0MM X 120MM X 150CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION IN THE LEFT SFA. DURING THE FIRST INFLATION, TO 13 ATMOSPHERES, THE BALLOON RUPTURED. A SAME SIZE ARMADA 18 WAS USED WITHOUT ISSUE. A 3.0MM X 100MM X 150CM ARMADA 18 BDC WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION IN THE ANTERIOR TIBIAL ARTERY. DURING THE FIRST INFLATION, TO 13 ATMOSPHERES, THE BALLOON RUPTURED. A SAME SIZE ARMADA 18 WAS USED WITHOUT ISSUE. 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 13940623 ↗
• MalfunctionDec 20, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LONG LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. AN ANTEGRADE ACCESS WAS USED IN THE RIGHT COMMON FEMORAL VEIN. A COMMAND GUIDE WIRE SUCCESSFULLY CROSSED THE TARGET LESION. THEN A 6.0X150MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE; HOWEVER, THE BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. THEREFORE, THE BALLOON WAS REMOVED AND THE PROCEDURE CONTINUED WITH A 6.0X120 MM ARMADA 18 BDC. THE NEW ARMADA WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE; HOWEVER, THE BALLOON RUPTURED AT 4 ATMOSPHERES DURING THE FIRST INFLATION. THE BALLOON WAS REMOVED AND A DECISION WAS MADE TO LASER THE LESION. THEN ANOTHER ARMADA BDC WAS SUCCESSFULLY USED TO DILATE THE LESION. 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 13043345 ↗
• MalfunctionJun 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. AFTER LASER ATHERECTOMY WAS PERFORMED, A 6X120MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATMS). THEN, A 6X120MM ARMADA 35 PTA CATHETER WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMS. A NON-ABBOTT 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 12067812 ↗
• MalfunctionApr 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY. NO CALCIFICATION OR TORTUOSITY WAS NOTED. ATHERECTOMY WAS PERFORMED AND THEN 3 ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS WERE USED. TWO ARMADA 18 6.0X120 MM PTA CATHETERS RUPTURED ON THE FIRST INFLATION TO 7 OR 8 ATMOSPHERES (ATM), AND AN ARMADA 18 6.0X80 MM PTA CATHETER ALSO RUPTURED ON THE FIRST INFLATION TO 7 OR 8 ATM. THERE WAS NO NOTED RESISTANCE DURING ADVANCEMENT OR REMOVAL. A NON-ABBOTT BALLOON WAS USED LAST AND ALSO RUPTURED. A SUPERA SELF-EXPANDING STENT WAS THEN SUCCESSFULLY DEPLOYED 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: Insufficient Information

  MAUDE report 11735355 ↗
• MalfunctionApr 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY. NO CALCIFICATION OR TORTUOSITY WAS NOTED. ATHERECTOMY WAS PERFORMED AND THEN 3 ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS WERE USED. TWO ARMADA 18 6.0X120 MM PTA CATHETERS RUPTURED ON THE FIRST INFLATION TO 7 OR 8 ATMOSPHERES (ATM), AND AN ARMADA 18 6.0X80 MM PTA CATHETER ALSO RUPTURED ON THE FIRST INFLATION TO 7 OR 8 ATM. THERE WAS NO NOTED RESISTANCE DURING ADVANCEMENT OR REMOVAL. A NON-ABBOTT BALLOON WAS USED LAST AND ALSO RUPTURED. A SUPERA SELF-EXPANDING STENT WAS THEN SUCCESSFULLY DEPLOYED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11735303 ↗
• MalfunctionDec 17, 2020Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY THAT WAS MODERATELY CALCIFIED. THE ARMADA 18 WAS ADVANCED TO THE LESION AND WHILE ATTEMPTING TO INFLATE, A LEAK WAS SUSPECTED AS THE BALLOON FILLED WITH BLOOD. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE ARMADA WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11032871 ↗
• MalfunctionDec 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TO TREAT THE HEAVY CALCIFIED, MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY (RSFA). THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE 6.0X12 MM ARMADA 18 TO THE R SFA. THE ARMADA WAS FIRST INFLATED TO 8 ATMOSPHERES (ATMS) WITHOUT INCIDENT. WHEN THE ARMADA WAS INFLATED TO 12 ATMS, THE ARMADA RUPTURED, BUT REMAINED IN ONE PIECE. THE RUPTURED ARMADA WAS REMOVED WITHOUT INCIDENT. A 7X40 MM ANGIOSCULPT DEVICE WAS USED AS A SCORING BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10977623 ↗
• MalfunctionSep 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE ARMADA 18 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE DEVICE WAS EASILY REMOVED FROM THE PATIENT ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS THEN USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10500210 ↗
• MalfunctionApr 22, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. BOTH ARMADA 18 BALLOONS (6.0X120MM AND 6.0X100MM) RUPTURED AT 10 ATM DURING THE FIRST INFLATION. A NON-ABBOTT 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 Consequences Or Impact To Patient

  MAUDE report 9986710 ↗
• MalfunctionFeb 24, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION LOCATED IN THE RIGHT POPLITEAL ARTERY THAT WAS MODERATELY CALCIFIED. THE FIRST ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION. DURING THE SECOND INFLATION AT 10 ATMOSPHERES (ATM), THE BALLOON RUPTURED. A SECOND ARMADA BDC WAS ADVANCED TO THE LESION AND AT 8 ATMOSPHERES, AND DURING THE SECOND INFLATION AT 8 ATM, THE BALLOON RUPTURED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745904 ↗
• MalfunctionFeb 24, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION LOCATED IN THE RIGHT POPLITEAL ARTERY THAT WAS MODERATELY CALCIFIED. THE FIRST ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION. DURING THE SECOND INFLATION AT 10 ATMOSPHERES (ATM), THE BALLOON RUPTURED. A SECOND ARMADA BDC WAS ADVANCED TO THE LESION AND AT 8 ATMOSPHERES, AND DURING THE SECOND INFLATION AT 8 ATM, THE BALLOON RUPTURED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745896 ↗
• MalfunctionDec 7, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION. A 6.0 X 120 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED TO THE LESION WITH NO RESISTANCE; HOWEVER, ON THE INITIAL INFLATION OF THE BALLOON, THE DEVICE WAS UNABLE TO MAINTAIN NOMINAL PRESSURE AND A PIN HOLE WAS NOTED. THE PTA BALLOON CATHETER WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW ARMADA PTA BALLOON 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 8144226 ↗
• MalfunctionJun 7, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 6.0 X 120 MM ARMADA 18 DILATATION CATHETER WAS ADVANCED WITHOUT DIFFICULTY FOR POST-DILATATION OF AN UNSPECIFIED STENT. THE DILATATION CATHETER BALLOON WAS INFLATED TO 8 ATMOSPHERES AND RUPTURED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND NO PORTION REMAINS IN THE PATIENT ANATOMY. A SECOND ARMADA 18 WAS USED WITHOUT ISSUE. 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 7580286 ↗
• MalfunctionMay 29, 2018Leak/Splash

  IT WAS REPORTED THAT DURING DEVICE PREPARATION AND PRIOR TO USE, WHILE PULLING NEGATIVE PRESSURE THE ARMADA BALLOON DILATATION CATHETER LEAKED AT THE HUB AREA. THERE WAS NO PATIENT INTERACTION AS THE DEVICE WAS NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7551391 ↗