Armada B2050-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648155185), received between Jan 16, 2017 and Oct 28, 2025 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS OF THE SUPERFICIAL FEMORAL ARTERY. THE 5.0X60MM ARMADA 35 BALLOON CATHETER WAS USED TO PREPARE THE VESSELS; HOWEVER, DURING THE PROCEDURE THE BALLOON WAS INFLATED TO 2 AND 8 ATMOSPHERES WHEN THE BALLOON WAS OBSERVED TO BE LEAKING CONTRAST. THERE BALLOON WAS REMOVED AND REPLACED WITH ANOTHER SAME SIZE ARMADA 35. THERE WAS 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 23407129 ↗
• MalfunctionApr 25, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. A 5X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE INFLATED; HOWEVER, A LEAK AT THE PORT CONNECTOR [HUB] WAS NOTED. THEREFORE, THE BDC COULD NOT BE USED AND WAS EXCHANGED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910334 ↗
• MalfunctionApr 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 98% STENOSED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. A 5.00 X 60MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION ON A 0.035 UNSPECIFIED GUIDEWIRE; HOWEVER, DURING THE SECOND INFLATION THE BALLOON RUPTURED AT 8 ATMOSPHERES AFTER 2 MINUTES DUE TO HEAVY CALCIFICATION IN THE LESION. THE BDC WAS REMOVED FROM THE PATIENT AND A 6.00 X 80MM ABSOLUTE STENT WAS IMPLANTED. THEN POST-DILATATION WAS PERFORMED WITH A 5.00 X 40MM ARMADA BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION REGARDING THIS ISSUE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047460 ↗
• MalfunctionNov 24, 2021Leak/Splash; Leak/Splash

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE FOLLOWING CLARIFIED INFORMATION WAS PROVIDED: IT WAS REPORTED THAT DURING PREPARATION OF THE 5.0 X 40 MM ARMADA 35 BALLOON CATHETER, AN AIR LEAK WAS NOTED. THEREFORE, THE BALLOON CATHETER WAS NOT USED AND EXCHANGED FOR A NEW ARMADA 35 BALLOON CATHETER. 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 12869073 ↗
• MalfunctionNov 24, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 5.0 X 60 MM ARMADA 35 BALLOON CATHETER, AN AIR LEAK WAS NOTED. THEREFORE, THE BALLOON CATHETER WAS NOT USED AND EXCHANGED FOR A NEW ARMADA 35 BALLOON CATHETER. 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 12869041 ↗
• InjuryJul 10, 2020Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT ILIAC ARTERY. A 8X20MM ARMADA 35 BALLOON WAS ADVANCED TO THE LESION AND INFLATED ONCE, WHEN THE BALLOON RUPTURED AT 8 ATMOSPHERES. WHEN REMOVING THE DEVICE, IT GOT STUCK ON THE GUIDE WIRE. THE PHYSICIAN KEPT PULLING AGAINST RESISTANCE, WHEN THE DEVICE SEPARATED AND CAME OUT. ANGIOGRAPHY NOTED THAT THE DISTAL PORTION (INCLUDING DISTAL MARKER AND HALF OF BALLOON) REMAINED IN THE ANATOMY. THE BUDDY WIRE TECHNIQUE WAS PERFORMED TO REMOVE THE SEPARATED PORTION SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO FILING THE INITIAL MDR, THE FOLLOWING INFORMATION WAS RECEIVED: DEVICE ANALYSIS NOTED A 300 CM LENGTH SUPRA CORE GUIDE WIRE WAS RECEIVED FROZEN INSIDE THE BALLOON CATHETER WITH BENT CORE. THE ACCOUNT CONFIRMED THE SUPRA CORE GUIDE WIRE WAS USED ALONGSIDE THE ARMADA BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10257710 ↗
• MalfunctionOct 29, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN CORONARY LESION. THE ARMADA 35 ARMADA 35 5MM/60MM BALLOON WAS ADVANCED; HOWEVER, RUPTURED AT 8 ATMOSPHERES. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE AND AIR ASPIRATION OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT REMAINS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8016638 ↗
• MalfunctionApr 11, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT BRACHIOCEPHALIC VEIN. DURING THE PROCEDURE, A 5.0 X 60MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED AT 6-8 ATMOSPHERES DURING THE FIRST INFLATION. ALL PRESSURE WAS LOST AND THE DEVICE WAS SIMPLY REMOVED. ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE, FOLLOWED BY A DRUG-COATED BALLOON. 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 7423734 ↗
• MalfunctionMar 23, 2018Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 5X60MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED WITHOUT RESISTANCE TO THE LESION. UPON INFLATION TO THE RATED BURST PRESSURE (RBP) OF 20 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER ARMADA 35 OF THE SAME SIZE 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 7367858 ↗
• MalfunctionJan 24, 2018Deflation Problem; Difficult to Remove; Folded

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERIPHERAL PROCEDURE, TREATING A TARGET LESION IN THE RIGHT ILIAC ARTERY. THE ARMADA 35 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION AND WAS INFLATED 1 TIME, TO 18 ATMOSPHERES (ATM) AND DEFLATED WITHOUT ISSUE. THE DEVICE WAS INFLATED A SECOND TIME, TO 18 ATM, BUT DEFLATED SLOWLY. DIFFICULTY WAS NOTED REMOVING THE DEVICE, AND UPON REMOVAL, THE BALLOON WAS NOTED TO HAVE BUNCHED UP TOWARDS THE TIP OF THE DEVICE. A SECOND UNSPECIFIED DILATATION CATHETER WAS USED, AND WAS FOLLOWED BY STENTING. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7216017 ↗
• MalfunctionMay 31, 2017Deflation Problem

  IT WAS REPORTED THAT AN ARMADA DILATATION CATHETER ADVANCED TO THE LEFT SUPERFICIAL FEMORAL ARTERY LESION AND DILATATION WAS PERFORMED WITHOUT ISSUE. FOLLOWING, THE BALLOON FAILED TO DEFLATE. A SYRINGE WAS ATTACHED TO THE DEVICE IN AN ATTEMPT TO ASPIRATE THE BALLOON. THERE WAS NO SUCCESS. THE DEVICE WAS CAREFULLY RETRACTED TO THE GUIDE CATHETER. ANOTHER SYRINGE WAS ATTACHED TO ASPIRATE THE BALLOON WITH SLIGHT SUCCESS. THE DEVICE WAS PLACED INTO THE GUIDE CATHETER AND ALL WAS REMOVED FROM THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS DEVICE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6603203 ↗
• InjuryMay 19, 2017Deflation Problem

  IT WAS REPORTED THAT AN ARMADA DILATATION CATHETER ADVANCED TO THE ILIAC ARTERY LESION AND BALLOON INFLATION WAS PERFORMED WITHOUT ISSUE. FOLLOWING, THE BALLOON FAILED TO DEFLATE. A SYRINGE WAS ATTACHED AND ASPIRATION WAS PERFORMED TO DEFLATE THE BALLOON. THE DEVICE WAS REMOVED WITHOUT ANY FURTHER ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS A 10-MINUTE DELAY; HOWEVER, NO CLINICAL SYMPTOMS WERE ASSOCIATED WITH THIS DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6578467 ↗
• MalfunctionMar 10, 2017Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TOTALLY OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY. POST-DILATATION OF AN UNKNOWN STENT WAS PERFORMED WITH A 5.0 X 60 MM ARMADA 35 BALLOON CATHETER INFLATED 2 TIMES TO 8 ATMOSPHERES; HOWEVER, THE BALLOON WAS VERY SLOW TO DEFLATE, ALTHOUGH IT DID FINALLY FULLY DEFLATE. THE CATHETER WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED AT THIS TIME. 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 6397576 ↗
• MalfunctionFeb 21, 2017Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WOULD NOT DEFLATE. THE BDC WAS REMOVED PARTIALLY DEFLATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNKNOWN BALLOON. 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 6346461 ↗
• MalfunctionJan 16, 2017Deflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE NON-TORTUOUS, NON-CALCIFIED, SUPERFICIAL FEMORAL ARTERY (SFA), THE ARMADA 35 BALLOON WAS INFLATED WITHOUT ISSUE, BUT DEFLATION WAS SLOW. THERE WAS NO REPORTED 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 6254934 ↗