Armada A2025-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648156021), received between Aug 15, 2018 and Aug 8, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2024Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE TIBIAL ARTERY. REPORTEDLY A 2.5X60MM ON 150CM ARMADA 14 BALLOON DILATATION CATHETER (BDC), WAS PREPARED, HOWEVER BUBBLES WERE NOTED WHEN A NEGATIVE PRESSURE WAS APPLIED. THE BDC WAS STILL USED TO DILATE THE LESION, AND FOLLOWING ITS REMOVAL IT WAS NOTED TO HAVE A LEAK COMING FROM THE DISTAL END OF THE HUB. 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 19937443 ↗
• MalfunctionApr 3, 2024Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS PERONEAL ARTERY THAT IS 80% STENOSED. THE 2.5X60MM ARMADA 14 BALLOON CATHETER WAS NOT AIR ASPIRATED OUTSIDE THE ANATOMY PRIOR TO USE. ONCE AT THE LESION, THE BALLOON WOULD NOT HOLD PRESSURE AFTER INFLATION TO NOMINAL PRESSURE AND WAS NOTED TO BE DEFLATING. HOWEVER, BALLOON ANGIOPLASTY WAS COMPLETED WITH THE SAME ARMADA AND THEN THE DEVICE WAS REMOVED. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033495 ↗
• MalfunctionMar 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION BEHIND THE KNEE WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE 2.5X60 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION AND IT WAS NOTED THAT THE BALLOON WAS LEAKING BEFORE DILATATION. THE DEVICE WAS REMOVED AND A NEW 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18979382 ↗
• MalfunctionSep 20, 2023Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR TIBIAL ARTERY THAT WAS MODERATELY CALCIFIED. THE ACCESS SITE WAS THE LEFT COMMON FEMORAL VIA 6FR SHEATH. REPORTEDLY, THE ARMADA BALLOON CATHETER WOULD NOT ADVANCE THROUGH THE ACCESS SITE AND THE TIP WAS BENT. THE DEVICE WAS CAUGHT/HOOKED ONTO THE GUIDE WIRE, AND THE DEVICES COULD NOT BE REMOVED INDEPENDENTLY SO THE ARMADA WAS REMOVED WITH THE GUIDE WIRE, LOSING ACCESS SITE. ANOTHER ARMADA WAS USED TO CONTINUE THE PROCEDURE WITH NO HARM TO THE PATIENT. THERE WERE NO REPORTED 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 17782613 ↗
• MalfunctionJul 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 2.5X60 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED. ANOTHER ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 17367253 ↗
• MalfunctionFeb 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING PREPARATION OF A 2.5X60MM ARMADA 14 BALLOON DILATATION CATHETER THE DEVICE WOULD NOT HOLD PRESSURE WHEN ATTEMPTING TO INFLATE. A LEAK WAS NOTED ON THE ACTUAL BALLOON. ANOTHER UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541808 ↗
• MalfunctionMar 10, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. A 2X120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS ADVANCED WITHOUT RESISTANCE. THE BALLOON COMPLETELY FAILED TO INFLATE WHILE LOSING PRESSURE AS A BALLOON RUPTURE WAS NOTED. A 2.5X60MM ARMADA 14 PTA WAS ADVANCED, AND THE BALLOON PARTIALLY INFLATED ONLY UP TO 4 ATMOSPHERES BUT WAS ALSO LOSING PRESSURE AS A PINHOLE BALLOON RUPTURE WAS NOTED. A 2X60MM ARMADA 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 11454523 ↗
• MalfunctionSep 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED PERIPHERAL ARTERY. AN ARMADA 14 WAS ADVANCED TO THE LESION WITHOUT ISSUE. THE BALLOON WAS INFLATED ONCE AND RUPTURED AT 10 ATMOSPHERES. THE DEVICE WAS SIMPLY REMOVED. 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 Consequences Or Impact To Patient

  MAUDE report 10600343 ↗
• MalfunctionSep 13, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE ILIAC ARTERY. THE 2.5X60MM ARMADA 14 BALLOON CATHETER WAS ADVANCED TO THE LESION WITH NO RESISTANCE NOTED. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 2 ATMOSPHERES. THE DEVICE WAS REMOVED WITH NO ISSUE AND REPLACED WITH ANOTHER ARMADA 14 TO COMPLETE THE PROCEDURE. 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 7875166 ↗
• MalfunctionAug 15, 2018Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LOWER EXTREMITY. RESISTANCE BETWEEN A 2.5MM X 60MM X 150 CM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AND AN ASAHI GLADIUS GUIDEWIRE WAS FELT. THE GUIDEWIRE BECAME STUCK IN THE BALLOON CATHETER AND WAS UNABLE TO BE REMOVED. THE BALLOON CATHETER AND GUIDEWIRE WERE REMOVED FROM THE PATIENT ANATOMY TOGETHER AS A SINGLE UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ADDITIONAL ARMADA 14 BALLOON CATHETER AND A COMMAND GUIDEWIRE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS A REPORTED DELAY IN PROCEDURE; HOWEVER, THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7785317 ↗