Armada B2070-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648155413), received between Jan 23, 2018 and Jun 24, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION WITH 80% OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS PREPARED USING ATHERECTOMY AND THEN A 7.0X200MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED FOR PRE-DILATATION HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. AFTER REMOVAL OF THE ARMADA 35, A MINOR PERFORATION WAS NOTED. ANOTHER BALLOON CATHETER WAS USED IN THE ATTEMPT TO SEAL WITH THE PERFORATION WITH PROLONGED BALLOON INFLATIONS HOWEVER WAS UNSUCCESSFUL. A 7.0X60MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED OVER A 18 VIPER WIRE TO THE TARGET LESION HOWEVER THE THUMBWHEEL WOULD NOT ADVANCE AND THE STENT COULD NOT BE DEPLOYED. THE SES WAS REMOVED WITHOUT ISSUE AND ANOTHER NON-ABBOTT STENT WAS USED TO CONTINUE THE PROCEDURE. POST DILATATION OF THE STENT WAS PERFORMED AND THE PERFORATION WAS SEALED. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 22318757 ↗
• MalfunctionAug 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT EXTERNAL ILIAC ARTERY. REPORTEDLY A 7.0 X 200MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED FOR DILATATION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THE BDC WAS REMOVED, AND ANOTHER ARMADA 35 OF THE SAME SIZE WAS USED, HOWEVER DURING ITS THIRD INFLATION THE BALLOON RUPTURED AT 6ATM. THE DEVICE WAS REMOVED WITH SLIGHT RESISTANCE AND WAS NOTED TO HAVE A SEPARATED TIP. THE SEPARATED PORTION WAS STUCK RIGHT AT THE SKIN LEVEL THEREFORE IT WAS SIMPLY WITHDRAWN WITH THE DELIVERY SHEATH. A NEW ARMADA 35 WAS USED AND THE PROCEDURE WAS COMPLETED. 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 20064941 ↗
• MalfunctionAug 26, 2024Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT EXTERNAL ILIAC ARTERY. REPORTEDLY A 7.0 X 200MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED FOR DILATATION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THE BDC WAS REMOVED, AND ANOTHER ARMADA 35 OF THE SAME SIZE WAS USED, HOWEVER DURING ITS THIRD INFLATION THE BALLOON RUPTURED AT 6ATM. THE DEVICE WAS REMOVED WITH SLIGHT RESISTANCE AND WAS NOTED TO HAVE A SEPARATED TIP. THE SEPARATED PORTION WAS STUCK RIGHT AT THE SKIN LEVEL THEREFORE IT WAS SIMPLY WITHDRAWN WITH THE DELIVERY SHEATH. A NEW ARMADA 35 WAS USED AND THE PROCEDURE WAS COMPLETED. 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 20064929 ↗
• MalfunctionJun 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT POPLITEAL ARTERY. THE 7.0X200MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND INFLATED ONCE AT 4 ATMOSPHERES (ATMS) BUT THE BALLOON RUPTURED. THE BALLOON WAS REMOVED (CONFIRMED NOTHING LEFT IN PATIENT) AND ANOTHER SAME SIZE ARMADA 35 BALLOON WAS USED TO CONTINUE AND COMPLETE THE PROCEDURE. 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 19489731 ↗
• MalfunctionApr 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND NO TORTUOSITY. THE 7X200 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED ON THE FIRST INFLATION AT 8 ATMOSPHERES. ANOTHER SAME SIZE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16812114 ↗
• MalfunctionFeb 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A SEVERELY STENOTIC LEFT SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION, TWO ARMADA BALLOON CATHETERS WERE USED AND RUPTURED. THE FIRST ARMADA BALLOON RUPTURED DURING THE 1ST INFLATION AT 6 ATMOSPHERES (ATM). THE SECOND ARMADA RUPTURED DURING THE 1ST INFLATION, AT 7 ATM. THE DEVICES WERE REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11369817 ↗
• MalfunctionFeb 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A SEVERELY STENOTIC LEFT SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION, TWO ARMADA BALLOON CATHETERS WERE USED AND RUPTURED. THE FIRST ARMADA BALLOON RUPTURED DURING THE 1ST INFLATION AT 6 ATMOSPHERES (ATM). THE SECOND ARMADA RUPTURED DURING THE 1ST INFLATION, AT 7 ATM. THE DEVICES WERE REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11369816 ↗
• MalfunctionJan 22, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. A 7.0 X 200 MM ARMADA 35 PERCUTANEOUS BALLOON ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED WITH NO REPORTED RESISTANCE; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION BELOW RATED BURST PRESSURE. THE PTA BALLOON CATHETER WAS SIMPLY REMOVED AND A NEW UNSPECIFIED BALLOON CATHETER 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 8269496 ↗
• InjuryOct 5, 2018Deflation Problem; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE ACCESS SITE WAS THE RIGHT COMMON FEMORAL ARTERY. AN UNSPECIFIED SUPERA STENT WAS IMPLANTED AT THE LESION AND POST-DILATATION WAS PERFORMED WITH A 7.0 X 200 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC). THE ARMADA BDC DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT; HOWEVER, DEFLATION TIME WAS INSUFFICIENT AND A WAIST OCCURRED IN THE BALLOON BECAUSE THE DISTAL PART STILL HAD CONTRAST INSIDE IT. THE TOP HALF OF THE BALLOON DEFLATED FAST; HOWEVER, REMOVAL OF THE BALLOON WAS STARTED BEFORE THE REST OF THE BALLOON HAD FULLY DEFLATED. THEREFORE, THE BALLOON SEPARATED INTO TWO SEPARATE PIECES. PART OF THE BALLOON WAS INSIDE THE SUPERA STENT AND THE OTHER PART WAS INSIDE THE INTRODUCER SHEATH. THE DEVICE WAS REMOVED WITH THE INTRODUCER SHEATH TO REMOVE HALF OF THE BALLOON, AND THE OTHER HALF THAT WAS INSIDE THE SUPERA STENT WAS REMOVED VIA CUT-DOWN PROCEDURE. THE SUPERA STENT WAS NOT DAMAGED BY THE ARMADA 35 BDC; HOWEVER, THE STENT WAS ALSO REMOVED TO REMOVE THE REMAINING HALF OF THE ARMADA BALLOON. THE DISTAL MARKERS THAT SEPARATED AS WELL WERE ALSO REMOVED VIA CUT-DOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7938405 ↗
• MalfunctionFeb 14, 2018Material Rupture

  IT WAS REPORTED THAT A 7X200MM ARMADA 35 BALLOON CATHETER RUPTURED DURING FIRST INFLATION AT 11 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW ARMADA 35 BALLOON CATHETER. 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 7271361 ↗
• MalfunctionJan 23, 2018Crack; Inflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN OCCLUDED PREVIOUSLY DEPLOYED STENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 7X200 ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH NO RESISTANCE. THE BDC WAS NOT PREPPED PRIOR TO INSERTION. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON HOWEVER IT WOULD NOT INFLATE DUE TO A CRACK IN THE HUB. THE DEVICE WAS REPLACED WITH A NEW BALLOON CATHETER 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 7213965 ↗