Armada B2050-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08717648155178), received between Nov 4, 2016 and Nov 18, 2025 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 19 most recent of 19 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 23580870 ↗
• MalfunctionNov 14, 2025Break; Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance; Break; Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS UPDATED: IT WAS REPORTED THAT DURING REMOVAL OF THE 5.0X40MM ARMADA 35 BALLOON DILATATION CATHETER, THE BALLOON DID NOT FRACTURE, BUT SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560224 ↗
• MalfunctionFeb 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). THE 5X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION VIA 6FR SHEATH USING THE CROSSOVER APPROACH. THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, THE BALLOON FAILED TO INFLATE AND WHEN NEGATIVE WAS PULLED AIR WAS NOTED TO BE ENTERING THE INFLATION DEVICE. THEN A 10CC SYRINGE WAS USED TO PULL NEGATIVE AND AIR WAS NOTED IN THE SYRINGE. ANOTHER ARMADA 35 BALLOON WAS USED TO CONTINUE THE PROCEDURE. 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 21293137 ↗
• MalfunctionMay 2, 2024Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (RSFA). THE 5X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE THE BALLOON WAS INFLATED TO 12 ATMOSPHERES (ATM); HOWEVER, A LEAK WAS NOTED OUTSIDE THE ANATOMY AT THE BLACK PART OF THE HUB. THE LEAK WAS NOTED BY A DRIP OF THE CONTRAST/SALINE MIXTURE. THE BALLOON WAS ABLE TO BE DEFLATED AND REMOVED FROM THE PATIENT WITHOUT ISSUE. 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 19233115 ↗
• InjurySep 11, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED IT WAS NOTED THE FOURTH PIECE WAS REMOVED VIA OPEN SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Pain

  MAUDE report 17722858 ↗
• InjuryOct 31, 2022Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED ILIAC ARTERY. THE 5.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED AT AN UNKNOWN PRESSURE AND DURING REMOVAL THE BDC BECAME STUCK IN THE INTRODUCER. THE UNSPECIFIED GUIDE CATHETER BECAME BROKEN; THEREFORE, THE INTRODUCER, GUIDE AND BALLOON WERE REMOVED AS A SINGLE UNIT WITH GREAT DIFFICULTY. IT WAS NOTED RESISTANCE WITH ANATOMY WAS FELT DURING REMOVAL OF THE ENTIRE UNIT. THE PATIENT SUFFERED MODERATE BLEEDING (DISSECTION). IT IS UNKNOWN IF ANY TREATMENT WAS PROVIDED TO TREAT THE MODERATE BLEEDING. THERE WERE NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 15704592 ↗
• MalfunctionJul 13, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-TORTUOUS AND NON-CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 5.0X40MM ARMADA 35 BALLOON CATHETER WAS ADVANCED WITHOUT RESISTANCE, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNSPECIFIED ARMADA 35 BALLOON CATHETER. 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 12162887 ↗
• MalfunctionSep 30, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY CALCIFIED, MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). REPORTEDLY, ALL STEPS FOR PREPARATION OF THE 5 X 40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WERE PERFORMED PER THE INSTRUCTIONS FOR USE. THE CATHETER WAS ADVANCED TO THE LESION AND POSITIONED; HOWEVER, THE BALLOON WOULD NOT INFLATE AND A LEAK WAS NOTED AT THE HUB. THE DEVICE WAS REMOVED AND A 5 X 60 MM ARMADA 35 PTA CATHETER 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 Consequences Or Impact To Patient

  MAUDE report 9136752 ↗
• MalfunctionSep 24, 2019Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 5.0X40MM ARMADA 35 BALLOON DILATATION CATHETER REMAINED INFLATED FOR AN EXTENDED PERIOD OF TIME EVEN AFTER 3 ATTEMPTS OF DEFLATION. IT IS UNKNOWN HOW THE DEVICE WAS REMOVED. ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. 9/30/2019: ADDITIONAL INFORMATION WAS RECEIVED STATING: THE BALLOON WAS USED TO TREAT A LIMB ANGIOPLASTY. THE BALLOON ULTIMATELY DEFLATED AFTER MORE THAN 2 MINUTES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9109522 ↗
• MalfunctionApr 30, 2019Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED, COMMON ILIAC DE NOVO ARTERY THAT WAS 90% STENOSED. THE 5.0X40MM ARMADA 35 BALLOON DILATION CATHETER (BDC) REACHED THE LESION BUT MET RESISTANCE WITH THE ANATOMY. THE BALLOON RUPTURED AT FIRST INFLATION AT 8 ATMOSPHERES. AN UNSPECIFIED BDC 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 8566513 ↗
• MalfunctionNov 17, 2017Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RESTENOSIS LESION IN THE MILDLY TORTUOUS, MILDLY CALCIFIED, MID FEMORAL ARTERY. A 5.0 X 40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS SELECTED FOR THE PROCEDURE. THERE WAS NO ISSUE OR LEAK NOTED DURING PREPARATION (AIR ASPIRATION) PRIOR TO USE. THE PTA CATHETER WAS ADVANCED WITH NO RESISTANCE FELT TO THE LESION AND THE BALLOON WOULD NOT INFLATE. THE PTA CATHETER WAS REMOVED FROM THE ANATOMY AND REPLACED WITH A NEW UNSPECIFIED BALLOON CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PHYSICIAN TESTED THE PTA CATHETER AT THE PREPARATION TABLE AND FOUND THAT WHEN HE TRIED TO INFLATE THE BALLOON A LEAK WAS OBSERVED AT THE AREA WHERE THE PROXIMAL SHAFT AND HUB CONNECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7041357 ↗
• MalfunctionJun 30, 2017Device Damaged by Another Device

  IT WAS REPORTED THAT THE 5X40 MM ARMADA 35 WAS AT THE SEVERELY CALCIFIED, SEVERELY TORTUOUS RIGHT ILIAC ARTERY WHEN IT WAS DECIDED TO CHANGE OUT THE GUIDE WIRE. THE GUIDE WIRE WAS REMOVED AND REPLACED WITH A GLIDEWIRE. DURING ADVANCEMENT OF THE GLIDEWIRE, THE WIRE CAME OUT THE SIDE OF THE DISTAL SHAFT OF THE ARMADA, BUT IT DID NOT PERFORATE THE VESSEL. THE SHAFT REMAINED INTACT AND NO AIR ENTERED THE PATIENT FROM THIS ISSUE. ALL THE DEVICES WERE REMOVED AS A UNIT. ANOTHER GUIDE CATHETER WAS INSERTED AND AN ARMADA 18 WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER ISSUES. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6683134 ↗
• MalfunctionJun 28, 2017Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED TOTAL OCCLUSION IN THE NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). A 5.0MMX40MMX135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS UNPACKAGED AND PREPPED WITH A 50/50 CONTRAST MIX OUTSIDE OF THE PATIENT WITHOUT DIFFICULTY. THE ARMADA 35 BDC WAS THEN ADVANCED WITHOUT DIFFICULTY. THE BALLOON WAS INFLATED TO NOMINAL PRESSURE WITHOUT ISSUE. WHEN ATTEMPTING TO DEFLATE THE ARMADA 35 BALLOON, THE BALLOON FAILED TO DEFLATE AND, CONSEQUENTLY, WAS UNABLE TO BE REMOVED FROM THE VESSEL. SURGICAL INTERVENTION WAS PLANNED FOR DEFLATION OF THE BALLOON, HOWEVER, THE BALLOON WAS RE-INFLATED PAST ITS RATED BURST PRESSURE, THEN DEFLATION WAS RE-ATTEMPTED; WITH NEGATIVE PRESSURE DRAWN FOR 2 MINUTES, THE BALLOON WAS SLOW TO DEFLATE, BUT WAS ABLE TO BE COMPLETELY DEFLATED AND WITHDRAWN WITHOUT THE NEED FOR INTERVENTION. ANOTHER UNSPECIFIED ARMADA BDC WAS USED TO COMPLETE DILATATION. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6675715 ↗
• InjuryMay 24, 2017Detachment Of Device Component; Difficult to Remove

  THE FOLLOWING INFORMATION IS FROM A USER FACILITY MEDWATCH REPORT: PER RN DESCRIPTION: ARMADA 35 PTA CATHETER DETACHED WITHIN PATIENT. THE BALLOON WAS INFLATED THEN DEFLATED AND WHEN DR. WAS MOVING THE DEVICE OUT IT SNAPPED APART LEAVING HALF OF THE BALLOON INSIDE THE PATIENT. THE BALLOON WAS ABLE TO BE REMOVED. PER MD: THE PATIENT DID HAVE AN OCCLUSION OF THE INNOMINATE VEIN WITH SMALL COLLATERALS FILLING THAT REGION. THE DECISION WAS MADE TO INTERVENE. WE UPSIZED THE SHEATH TO A 7-FRENCH SHEATH AND CROSSED THE LESION WITH A BERENSTEIN CATHETER AS WELL AS A GLIDEWIRE. AFTER THIS WAS CROSSED, WE THEN USED A 6 X 200 MM ARMADA BALLOON TO BALLOON THE ENTIRE REGION. WE THEN USED AN 8 X 80 ARMADA BALLOON WITHOUT GOOD SUCCESS AND WE UPSIZED TO A 10 X 60 ARMADA BALLOON. THE ARMADA BALLOON WAS TAKEN DOWN, AND WHILE WITHDRAWING THE ARMADA BALLOON, THE PROXIMAL PORTION OF THE BALLOON BECAME DISRUPTED AND WAS ONLY PARTIALLY REMOVED. THE REMAINING DISTAL PORTION WAS STILL ON THE WIRE. WE THEN UPSIZED THE SHEATH TO A 10-FRENCH SHEATH AND USED BUDDY WIRE TECHNIQUE TO SNARE THE ROSEN WIRE AND REMOVED THE ENTIRE APPARATUS. WE THEN PLACED PRESSURE OVER THE WOUND, USED 4-0 MONOCRYL TO CLOSE THE SUBC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6589803 ↗
• MalfunctionMar 23, 2017Deflation Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. THE 5MM/40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION AND THE DEVICE WAS INFLATED ONCE TO 18 ATMOSPHERES WITHOUT ISSUE. BALLOON DEFLATION WAS SLOW, NEGATIVE WAS HELD FOR 90 SECONDS TO DEFLATE THE DEVICE. THE BALLOON ULTIMATELY DEFLATED AND WAS WITHDRAWN WITHOUT RESISTANCE. AT THIS POINT, THE PROCEDURE WAS COMPLETE AND NO ADDITIONAL DEVICE WAS REQUIRED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6428767 ↗
• MalfunctionMar 21, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED POPLITEAL ARTERY. A 5.0 X 40 MM ARMADA 35 BALLOON CATHETER WAS BEING INFLATED WHEN IT RUPTURED UNDER RATED BURST PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THE TIME OF THE RUPTURE. THERE WAS NO ADDITIONAL TREATMENT PROVIDED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6422260 ↗
• InjuryMar 3, 2017Deflation Problem

  IT WAS REPORTED THAT THE ARMADA 35 WAS INFLATED ONE TIME AT 10 ATMOSPHERES IN THE LEFT ARM ARTERIO-VENOUS FISTULA. NEGATIVE PRESSURE WAS HELD FOR TWO MINUTES, BUT THE ARMADA 35 WAS ONLY HALF-WAY DEFLATED. THE ARMADA WAS MASSAGED TO FULLY DEFLATE IT. IT WAS SUCCESSFULLY REMOVED FROM THE FISTULA. 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 6376908 ↗
• MalfunctionJan 3, 2017Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT POPLITEAL ARTERY. A 5.0X40MM ARMADA 35 WAS INFLATED TO 14 ATMOSPHERES (ATMS) FOR 10 SECONDS AND TO 12 ATMS FOR 10 SECONDS; HOWEVER, IT TOOK 7 MINUTES TO DEFLATE. A NEGATIVE WAS HELD FOR 5-7 MINUTES WITH A NON-ABBOTT INFLATION DEVICE AND A 20CC SYRINGE. ADDITIONALLY, THERE WAS RESISTANCE REMOVING THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT DEVICE. ALTHOUGH, THERE WAS A DELAY IN THE PROCEDURE IS WAS NOT CLINICALLY SIGNIFICANT. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6220159 ↗
• MalfunctionNov 4, 2016Deflation Problem; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 5MMX40MMX135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND WAS INFLATED WITHOUT ISSUE; HOWEVER, THE BALLOON FAILED TO DEFLATE. THE BDC WAS DIFFICULT TO RETRACT BACK INTO THE 6F SHEATH, SOME FORCE HAD TO BE USED TO REMOVE THE CATHETER THROUGH THE SHEATH. A SAME SIZE ARMADA 35 BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 6079219 ↗