Armada B2070-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648155383), received between Dec 6, 2016 and Feb 20, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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.

• InjuryFeb 20, 2025Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. TWO SUPERA STENTS, 6.0X150MM AND 5.5X150MM, WERE IMPLANTED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITHOUT ISSUES. THE 7.0X100MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION OF THE RIGHT EXTERNAL ILIAC ARTERY AND AN 8.0X100MM UNSPECIFIED STENT WAS IMPLANTED. THE SAME ARMADA BALLOON WAS USED FOR POST DILATATION APPROXIMATELY FOUR TIMES, AT 14 ATMOSPHERES (ATMS); HOWEVER, THE BALLOON RUPTURED. AN ATTEMPT WAS MADE TO REMOVE THE BDC BUT IT BECAME STUCK WHILE BEING PULLED THROUGH THE SHEATH, AND SEPARATED. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE SEPARATED PORTION OF THE BALLOON WITH A SNARE AND SUPPORT CATHETER BUT WERE UNSUCCESSFUL. IT WAS NOTED THAT THERE WAS SOME EXTENDED BLEEDING AROUND THE SHEATH OF THE LEFT RADIAL ARTERY. SURGICAL CUTDOWN AND ENDARTERECTOMY WERE PERFORMED AND NOTHING REMAINS IN THE PATIENT. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS NOTED AND THE PATIENT WILL REMAIN HOSPITALIZED FOR MULTIPLE DAYS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21423443 ↗
• MalfunctionSep 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 7.0X100MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED DURING POST DILATATION OF THE STENT AT 7 ATMOSPHERES DURING THE FIRST INFLATION. THE PROCEDURE COMPLETED WITHOUT USING A REPLACEMENT 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 17750328 ↗
• MalfunctionMar 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT EXTERNAL TO RIGHT COMMON ILIAC ARTERY. THE 7X100MM ARMADA 35 BALLOON CATHETER RUPTURED DURING THE SECOND INFLATION AT 3-4 ATMOSPHERES. A AN UNSPECIFIED STENT AND UNSPECIFIED BALLOON WERE 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 16604603 ↗
• InjuryFeb 8, 2023Difficult 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 PERFORMED IN THE SUBCLAVIAN TO TREAT A LESION IN THE ATRIOVENTRICULAR FISTULA (AV). THE FISTULA WAS USED FOR HEMODIALYSIS. THE LESION WAS PREDILATED WITH THE 7MM/100MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. THE DEVICE WAS ADVANCED WITHOUT RESISTANCE AND THEN INFLATED ONCE PASSING THE RATED BURST PRESSURE AND A RUPTURE OCCURRED AT 21 ATMOSPHERES. WHEN THE DEVICE WAS BEING PULLED OUT OF THE SHEATH MET RESISTANCE AND THE BALLOON MATERIAL SHEARED OFF. A SNARED DEVICE WAS USED TO RETRIEVED THE SEPARATION BALLOON MATERIAL. THE SAME ARMADA WAS USED TO 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 16325490 ↗
• MalfunctionApr 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED ILIAC ARTERY. A 7X100MM ARMADA 35 BALLOON WAS CHOSEN FOR PRE-DILATATION AND ADVANCED TO THE LESION. WHEN INFLATED ONCE AT 2 ATMOSPHERES THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER ARMADA 35 BALLOON 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 14224405 ↗
• MalfunctionApr 15, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LLIAC ARTERY. A 7.0X100MM ARMADA 35 WAS ATTEMPTED TO DILATE THE LESION BUT WOULD NOT INFLATE WHEN PRESSURE WAS ADDED. DEVICE WAS NOTED TO HAVE A LEAK, BUT IS UNKNOWN WHERE. ANOTHER ARMADA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9964923 ↗
• MalfunctionFeb 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION IN THE RIGHT ILIAC ARTERY. THE ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. THE BALLOON WAS INFLATED AND THE BALLOON RUPTURED AT 14 ATMOSPHERE AT THE FIRST INFLATION. THE BALLOON CATHETER WAS REMOVED WITHOUT ISSUE. 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 9758031 ↗
• MalfunctionNov 6, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE MILDLY TORTUOUS AND HEAVILY CALCIFIED LEFT EXTERNAL ILIAC ARTERY INTERVENTION, THE 6.0 X 40 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERE (ATM). A 7.0 X 100 MM ARMADA 35 BDC WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION, BUT AT THE FIRST INFLATION THE BALLOON RUPTURED AT 7 ATM. DURING DEPLOYMENT OF THE 8.0 X 100 ABSOLUTE PRO STENT, THE THUMBWHEEL WAS DIFFICULT AS IT WOULD STOP INTERMITTENTLY, BUT THE STENT WAS SUCCESSFULLY DEPLOYED. 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 8043423 ↗
• InjurySep 4, 2018Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-TORTUOUS AND MILDLY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. IT WAS REPORTED THAT A 7X100MM ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE LESION; HOWEVER, THE BALLOON RUPTURED DURING FIRST INFLATION AT 8 ATMOSPHERES. RESISTANCE WITH THE GUIDING CATHETER WAS FELT DURING REMOVAL. THE BALLOON SEPARATED AND A PORTION OF THE BALLOON WAS INSIDE THE PATIENT. A SNARE DEVICE WAS USED TO SUCCESSFULLY REMOVED THE SEPARATED BALLOON PIECE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7843630 ↗
• MalfunctionFeb 28, 2018Material Rupture

  IT WAS REPORTED THAT AN ARMADA DILATION CATHETER WAS ADVANCED TO THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY, HEAVILY CALCIFIED LESION WITHOUT ISSUE. BALLOON INFLATION WAS PERFORMED AT RATED BURST PRESSURE WHEN THE BALLOON BURST. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7304947 ↗
• MalfunctionApr 19, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. AFTER LASER ATHERECTOMY WAS PERFORMED, THE 7 MM/100 MM ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE LESION TO BE USED FOR PRE-DILATATION, WITHOUT RESISTANCE FELT, AND INFLATED. ON THE FIRST INFLATION OF 14 ATMOSPHERES THE BALLOON RUPTURED. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND A NEW BALLOON CATHETER WAS USED SUCCESSFULLY TO PERFORM PRE-DILATATION. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6505188 ↗
• MalfunctionDec 6, 2016Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY, A 7MM X 100 MM X 135 CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION. DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE BDC WAS REPLACED WITH A NEW UNSPECIFIED ARMADA 35 BDC TO 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 6149992 ↗