Armada B2070-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648155345), received between Jun 26, 2019 and May 28, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE 7X20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER ARMADA 35 BDC WAS ADVANCED AND THE SECOND ARMADA BALLOON ALSO RUPTURED DURING THE FIRST INFLATION AT 12 ATM. THE BDC WAS REMOVED FROM THE PATIENT. A THIRD ARMADA 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 22097685 ↗
• MalfunctionMay 28, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE 7X20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER ARMADA 35 BDC WAS ADVANCED AND THE SECOND ARMADA BALLOON ALSO RUPTURED DURING THE FIRST INFLATION AT 12 ATM. THE BDC WAS REMOVED FROM THE PATIENT. A THIRD ARMADA 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 22097572 ↗
• MalfunctionApr 21, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE RIGHT EXTERNAL ILIAC ARTERY. AN ABSOLUTE PRO STENT ADVANCED AND STENT DEPLOYMENT WAS PERFORMED WITHOUT ISSUES NOTED AT THAT TIME. FOLLOWING, AN ARMADA DILATATION CATHETER ADVANCED AND POST-DILATATION WAS PERFORMED WITHOUT ISSUES REPORTED. DURING ARMADA REMOVAL, RESISTANCE WAS MET. IT WAS THEN OBSERVED THAT THE ABSOLUTE PRO STENT HAD PARTIALLY DEPLOYED AT THE TARGET LESION AND PARTIALLY DEPLOYED IN THE SHEATH. THE ARMADA CATHETER HAD BECOME STUCK IN THE SHEATH AND IN THE PARTIALLY DEPLOYED ABSOLUTE PRO STENT. ALL WAS REMOVED, PARTIALLY DEPLOYED STENT, SHEATH, AND ARMADA CATHETER, AS A SINGLE UNIT. ANGIOPLASTY WAS PERFORMED ON THE TARGET LESION IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700952 ↗
• MalfunctionOct 20, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN A BYPASS GRAFT FROM THE COMMON FEMORAL ARTERY TO THE POPLITEAL ARTERY. A 7X20MM ARMADA 35 BALLOON CATHETER WAS USED FOR PRE-DILATATION. THE BALLOON CATHETER DEFLATED WITHOUT ISSUES AND WAS BEING REMOVED; HOWEVER, RESISTANCE WAS FELT WITH THE SHEATH AND BECAME STUCK. THE SHEATH AND BALLOON CATHETER HAD TO BE REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED 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 Consequences Or Impact To Patient

  MAUDE report 10708485 ↗
• InjuryOct 9, 2019Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY. A 7.0X20MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITH NO RESISTANCE NOTED. THE BALLOON WAS INFLATED ONCE AT AN UNSPECIFIED ATMOSPHERE AND RUPTURED. AS THE DEVICE WAS BEING REMOVED AND PULLED INTO THE SHEATH, RESISTANCE WAS MET WITH THE SHEATH AND IT WAS SUSPECTED THAT PART OF THE BALLOON BECAME LOST IN THE ANATOMY. THE DEVICE WAS SIMPLY REMOVED ALTOGETHER WITH THE SHEATH AND THE PROCEDURE WAS COMPLETED THEN. IT IS UNKNOWN IF PART OF THE BALLOON BECAME SEPARATED IN THE ANATOMY AND REMAINS THERE OR IF IT REMAINS IN THE SHEATH. THE PATIENT IS FINE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9173102 ↗
• MalfunctionAug 28, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BEFORE USE, A 7.0 X 20 MM ARMADA 35 BALLOON CATHETER FAILED TO PREP WHEN PULLING NEGATIVE AS THERE SEEMED TO BE A HOLE IN THE BALLOON. THEREFORE, AN UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8939595 ↗
• MalfunctionJun 26, 2019Device Difficult to Setup or Prepare; Material Rupture; Device Difficult to Setup or Prepare; Material Rupture

  IT WAS REPORTED THAT BEFORE USE, DURING PREP, THE PHYSICIAN DIDN'T FEEL CORRECT TENSION ON INFLATION DEVICE OF THE ARMADA 35 7MM/20MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. IT WAS BROUGHT TO THE BACK TABLE AND INFLATED AND RUPTURED AT 6 ATMOSPHERES. REPORTEDLY, THE DEVICE WAS PREPPED CORRECTLY PER THE INSTRUCTIONS FOR USE (IFU), BUT THE BALLOON DIDN'T FEEL RIGHT AND DIDN'T SEEM LIKE IT WAS PREPPING CORRECTLY. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW ARMADA 35 WAS USED TO SUCCESSFULLY 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 Patient Involvement

  MAUDE report 8735525 ↗