Armada A2040-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648156168), received between Oct 5, 2016 and Nov 11, 2025 — classified as 2 injuries, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PATENT BUT DAMAGED EXTERNAL ILIAC ARTERY WITH OCCLUSION OF THE COMMON FEMORAL ARTERY WITH BYPASS. A .014 NON-ABBOTT GUIDE WIRE FAILED TO ADVANCE THE DEEP FORMAL ARTERY; HOWEVER, EVENTUALLY ADVANCED THROUGH THE BYPASS. PRE-DILATATION WITH A 4.0 X 120 MM ARMADA 14 BALLOON WAS PERFORMED: HOWEVER, THE BALLOON RUPTURED LEAVING PART OF THE BALLOON INSIDE THE BYPASS AS CONFIRMED WITH IMAGING. THE SEPARATED PORTION OF THE BALLOON WAS ATTEMPTED TO BE RETRIEVED WITH A 5 X 100 MM ARMADA BALLOON; HOWEVER, THIS WAS UNSUCCESSFUL. A LONGITUDINAL INCISION (ARTERIOTOMY) WAS MADE AT THE GROIN WITH DISSECTION AND CONTROL OF THE BYPASS TO REPAIR THE COMMON FEMORAL ARTERY AND REMOVE THE SEPARATED PORTION OF THE BALLOON. THERE WAS NO ADVERSE PATIENT SEQUELA AND CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526430 ↗
• MalfunctionDec 2, 2024Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE RIGHT COMMON FEMORAL ARTERY. THE 4 X 120 MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER A .014 GUIDE WIRE (GW) TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO TREAT THE LESION; HOWEVER, DURING REMOVAL THE BDC BECAME STUCK WITH THE INTRODUCER SHEATH. THE SHAFT OF THE BDC BECAME STRETCHED AND SEPARATED AND A PORTION OF THE BDC REMAINED IN THE SHEATH. THE SHEATH WAS REMOVED WITH THE SEPARATED PORTION OF THE BDC. 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 20821825 ↗
• MalfunctionDec 6, 2022Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION. THE 4.0X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE DURING ADVANCEMENT THOUGH THE INTRODUCER SHEATH BUT WAS SUCCESSFULLY USED FOR DILATATION. THE BALLOON WAS DEFLATED, HOWEVER, COULD NOT BE PULLED BACK INTO THE SHEATH AND HAD RESISTANCE. FORCE WAS APPLIED BUT THE PHYSICIAN STOPPED AS HE COULD FEEL THE BALLOON DETACHING. THE SHEATH WAS REMOVED OVER THE GUIDE WIRE AND THE BALLOON FOLLOWED THE SHEATH AND WAS REMOVED. UPON INSPECTION, IT WAS NOTED THAT THE BALLOON SEPARATED FROM THE BALLOON CATHETER. THE SHEATH WAS REMOVED COMPLETELY BUT WAS ABLE TO REGAIN ACCESS. ADDITIONAL ANGIOGRAM PERFORMED SHOWED THAT FLOW HAD NOT BEEN AFFECTED. 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 15924239 ↗
• MalfunctionAug 29, 2022Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 100% STENOSIS AND MILD CALCIFICATION. THE 4.0X120MM ARMADA 14 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION AND INFLATED ONCE AT 8 ATMOSPHERES (ATMS). CONTRAST MIX WAS 70% SALINE AND 30% CONTRAST. DURING DEFLATION, THE BALLOON WOULD NOT DEFLATE WHEN THE INFLATION DEVICE PULLED NEGATIVE. THE INFLATION DEVICE WAS SWITCHED TO A 30ML SYRINGE, NEGATIVE WAS HELD FOR 40 SECONDS AND THE BALLOON WAS SLOWLY DEFLATED. THE BALLOON WAS WITHDRAWN ULTIMATELY DEFLATED. THERE WAS NO ISSUE WITH THE INFLATION DEVICE AS IT WAS USED SUCCESSFULLY THROUGHOUT THE PROCEDURE. THERE WAS NO RESISTANCE REMOVING THE DEFLATED BALLOON. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH AND THE DEVICE WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS 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 15316373 ↗
• MalfunctionOct 30, 2020Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT TIBIAL ARTERY. A 4X120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON WAS USED SUCCESSFULLY. THEN, THE PTA CATHETER WAS REMOVED WITHOUT RESISTANCE, AND THE PROCEDURE WAS COMPLETE. HOWEVER, AFTER REMOVAL, IT WAS NOTED THAT AN UNSPECIFIED GUIDE WIRE HAD CREATED A HOLE IN THE SHAFT NEAR THE BALLOON, AND THE TIP OF THE DEVICE WAS COLLAPSED. 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 10762993 ↗
• MalfunctionSep 15, 2020Material 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 LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY THAT WAS A CHRONIC TOTAL OCCLUSION. DURING THE 11TH INFLATION TO 18 ATMOSPHERES, WHICH WAS ABOVE THE RATED BURST PRESSURE, THE ARMADA 14 BALLOON RUPTURED. THE PROCEDURE WAS COMPLETE AT THAT POINT. THERE WAS NO REPORTED 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 10535488 ↗
• MalfunctionOct 1, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS DE NOVO POPLITEAL ARTERY. A 4.0X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER AN UNSPECIFIED GUIDE WIRE TO THE TARGET LESION. WHILE PRESSURIZING THE BDC, THE BALLOON DID NOT INFLATE AS FLUID LEAKED FROM THE HUB AT THE STRAIN RELIEF TUBING. THE BDC WAS REPLACED WITH A NEW SAME SIZE ARMADA 14 BDC 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 9140408 ↗
• MalfunctionSep 13, 2019Inflation Problem; Material Rupture; Deformation Due to Compressive Stress; Inflation Problem; Material Rupture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED, 60% STENOSED LEFT POPLITEAL AND TIBIAL ARTERIES. THE 4X120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED WITHOUT RESISTANCE, BUT WHEN ATTEMPTING TO INFLATE THE BALLOON, THE PTA COMPLETELY FAILED TO INFLATE DESPITE HOLDING PRESSURE. THE DEVICE WAS REMOVED WITH NO ISSUE; HOWEVER, THE SHAFT WAS NOTED TO BE SMASHED, AND A BALLOON RUPTURE HAD OCCURRED AT AN UNKNOWN PRESSURE. A 3X120MM 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 9038923 ↗
• InjuryOct 8, 2018Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN OCCLUDED, PREVIOUSLY STENTED LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 4.0 X 120 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED WITH NO REPORTED RESISTANCE AND THE BALLOON WAS INFLATED ONCE TO AN UNKNOWN PRESSURE. THERE WERE NO REPORTED PROBLEMS WITH DEFLATION. RESISTANCE OF AN UNKNOWN ORIGIN WAS MET WHEN ATTEMPTING TO REMOVE THE PTA BALLOON CATHETER. THE PTA BALLOON CATHETER WAS REMOVED AS A SINGLE UNIT; HOWEVER, OUTSIDE OF THE ANATOMY, IT WAS NOTED THAT THE BALLOON HAD SEPARATED FROM THE CATHETER AND WAS FOUND TO BE IN MULTIPLE PIECES. A BUDDY CATHETER WAS USED TO RETRIEVE ALL THE SEPARATED PIECES OF THE BALLOON FROM THE PATIENT'S ANATOMY AND CONTRAST WAS USED TO CONFIRM THE BUDDY CATHETER WAS SUCCESSFUL. NO FURTHER INTERVENTION WAS PERFORMED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7944345 ↗
• MalfunctionSep 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE POPLITEAL ARTERY. THE 4.0X120MM ARMADA 14 BALLOON CATHETER WAS ADVANCED TO THE LESION WITH NO RESISTANCE NOTED. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED WITH NO ISSUE AND REPLACED WITH ANOTHER BALLOON 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 7897740 ↗
• MalfunctionNov 4, 2016Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0 X 80 MM ARMADA 18 WAS ADVANCED TO THE TARGET LESION, BUT RUPTURED AT 8 ATMOSPHERE (ATM) DURING THE FIRST INFLATION. A 5.5 X 100 MM ARMADA 18 WAS ADVANCED TO THE TARGET LESION BUT RUPTURED AT 8 ATM DURING THE FIRST INFLATION AS WELL. A 4.0 X 12 MM ARMADA 14 WAS ADVANCED TO THE TARGET LESION; HOWEVER, A RUPTURE OCCURRED AT UNKNOWN PRESSURE DURING THE FIRST INFLATION. ANOTHER NEW ARMADA 14 WAS USED TO COMPLETE 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 6080881 ↗
• MalfunctionOct 5, 2016Material Rupture; Physical Resistance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS TREATED WITH AN ATHERECTOMY DEVICE SUCCESSFULLY. A 4.0 X 120 MM ARMADA BALLOON CATHETER WAS ADVANCED WITH SOME RESISTANCE WITH THE VESSEL TO THE TARGET LESION FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE SECOND INFLATION. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT ANY ISSUES. A NON-ABBOTT BALLOON CATHETER WAS USED TO COMPLETE PRE-DILATATION SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6001922 ↗