Armada B2070-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648155390), received between Nov 19, 2019 and May 28, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT IN-STENT RESTENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 7.0 X 120 MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 10 ATMOSPHERES. THE BALLOON WAS DEFLATED AS MUCH AS POSSIBLE HOWEVER DURING REMOVAL RESISTANCE WAS MET AND THE CATHETER SHAFT SEPARATED. A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED PORTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315324 ↗
• MalfunctionJun 30, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE 018 COMMAND ST GUIDE WIRE (GW) WAS ADVANCED THROUGH A 6FFSHEATH VIA LEFT GROIN ACCESS, UP AND OVER INTO RIGHT LEG. DURING ADVANCEMENT, RESISTANCE WAS NOTED THROUGHOUT THE WHOLE VESSEL DUE TO CALCIUM. THE VESSEL WAS PRE-TREATED TWICE WITH LASER ATHERECTOMY. FOLLOWING THIS, A 6.0X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE AND INFLATED IT TO 14 ATMS, FIVE TIMES, FOR 20 SECONDS EACH TIME. THE DECISION WAS MADE TO RE-TREAT THE LESION WITH THE LASER ATHERECTOMY. THE ARMADA 18 BDC WAS REMOVED, AND THE LASER ATHERECTOMY WAS PERFORMED. THE ARMADA 18 BDC WAS REINSERTED BACK INTO THE LESION AND INFLATED 9 TIMES AT 14 ATMS FOR 20 SECONDS; HOWEVER, THE BALLOON RUPTURED. THE BDC WAS REMOVED AND A 7X120MM ARMADA 35 BDC WAS ADVANCED WITH RESISTANCE DUE TO CALCIUM AND POSITIONED MORE PROXIMAL IN THE SFA. THE ARMADA 35 WAS INFLATED FOR 30 SECONDS AT 10 ATMS, THEN INFLATED AGAIN TO 10 ATMS FOR 10 SECONDS; HOWEVER, THE BALLOON RUPTURED ON THE SECOND INFLATION. THE BDC WAS REMOVED, AND TWO MORE PASSES WERE PERFORMED WITH THE LASER ATHERECTOMY DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365429 ↗
• MalfunctionJun 30, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE 018 COMMAND ST GUIDE WIRE (GW) WAS ADVANCED THROUGH A 6FFSHEATH VIA LEFT GROIN ACCESS, UP AND OVER INTO RIGHT LEG. DURING ADVANCEMENT, RESISTANCE WAS NOTED THROUGHOUT THE WHOLE VESSEL DUE TO CALCIUM. THE VESSEL WAS PRE-TREATED TWICE WITH LASER ATHERECTOMY. FOLLOWING THIS, A 6.0X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE AND INFLATED IT TO 14 ATMS, FIVE TIMES, FOR 20 SECONDS EACH TIME. THE DECISION WAS MADE TO RE-TREAT THE LESION WITH THE LASER ATHERECTOMY. THE ARMADA 18 BDC WAS REMOVED, AND THE LASER ATHERECTOMY WAS PERFORMED. THE ARMADA 18 BDC WAS REINSERTED BACK INTO THE LESION AND INFLATED 9 TIMES AT 14 ATMS FOR 20 SECONDS; HOWEVER, THE BALLOON RUPTURED. THE BDC WAS REMOVED AND A 7X120MM ARMADA 35 BDC WAS ADVANCED WITH RESISTANCE DUE TO CALCIUM AND POSITIONED MORE PROXIMAL IN THE SFA. THE ARMADA 35 WAS INFLATED FOR 30 SECONDS AT 10 ATMS, THEN INFLATED AGAIN TO 10 ATMS FOR 10 SECONDS; HOWEVER, THE BALLOON RUPTURED ON THE SECOND INFLATION. THE BDC WAS REMOVED, AND TWO MORE PASSES WERE PERFORMED WITH THE LASER ATHERECTOMY DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365426 ↗
• MalfunctionJan 31, 2022Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE 7.0 X 120 MM ARMADA 35 DILATATION CATHETER WAS PREPARED FOR USE AND NO ISSUES WERE NOTED. THE DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT DIFFICULTY AND THE BALLOON WAS INFLATED. THE BALLOON WAS INFLATED 1 TIME TO 7 ATMOSPHERES (ATM) AND A RUPTURE OCCURRED. A PORTION OF THE BALLOON SEPARATED AND DURING DEVICE REMOVAL, WITHOUT DIFFICULTY, THE SEPARATED SEGMENT WAS NOTED TO BE IN THE SHEATH AND DID NOT REMAIN IN THE PATIENT ANATOMY. ALL PARTS OF THE BALLOON WERE REMOVED WITHOUT INTERVENTION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13404977 ↗
• MalfunctionDec 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO 10 ATM AND RUPTURED. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. ANOTHER ARMADA 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 10994297 ↗
• InjuryNov 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 7.0X120 MM ARMADA 35 RUPTURED WITH THE FIRST INFLATION AT 14 ATMOSPHERES (RATED BURST PRESSURE) IN THE HEAVILY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. IN THE OPINION OF THE PHYSICIAN, THE RUPTURE WAS DUE TO THE CALCIFIED ANATOMY. A VESSEL PERFORATION OCCURRED WHICH WAS SUCCESSFULLY TREATED WITH A COVERED STENT. ANOTHER SAME SIZE ARMADA 35 WAS USED TO TREAT THE LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 9340984 ↗