Armada B1070-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648154775), received between Apr 30, 2018 and Nov 6, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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.

• MalfunctionNov 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE ILIAC ARTERY. THE 7.0X20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. THE BDC WAS REMOVED AND THE PROCEDURE COMPLETED USING ANOTHER 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 23485087 ↗
• MalfunctionJul 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN THE LEFT EXTERNAL ILIAC ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 7X20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT ABOUT 9-10 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT 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 22494856 ↗
• MalfunctionAug 6, 2024Off-Label Use; Material Rupture; Difficult to Advance; Off-Label Use; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE INTERVENTIONAL PROCEDURE WAS FOR THE TREATMENT OF STENOSIS IN THE LEFT SUBCLAVIAN ARTERY VIA THE RADIAL ARTERY ACCESS SITE WITH AN 0.035-INCH 300CM NON-ABBOTT GUIDEWIRE AND A 7FR SHEATH. A 4X20MM NON-ABBOTT DEVICE WAS DELIVERED AND INFLATION OF THE LESION SITE WAS ATTEMPTED, BUT THE LESION DID NOT DILATE. THE 9X29MM OMNILINK ELITE STENT DELIVERY SYSTEM WAS INITIALLY UNABLE TO CROSS THE PREDILATED LESION DUE TO THE CALCIFIED PLAQUES PROXIMAL TO THE LESION. THE 7X20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) MET RESISTANCE DURING ADVANCEMENT TO THE LESION, THEN THE ARMADA BALLOON RUPTURED WITH THE FIRST INFLATION AT 11 ATMOSPHERES DUE TO THE CALCIFIED PLAQUES. THE 7X40MM ARMADA BDC WAS USED AS A REPLACEMENT TO FURTHER PREDILATE THE LESION, THEN THE SAME 9X29 MM OMNILINK ELITE WAS SUCCESSFULLY DEPLOYED. SUBSEQUENTLY, AN 8X80MM NON-ABBOTT DEVICE WAS DEPLOYED IN THE SUBCLAVIAN ARTERY PROXIMAL TO THE LESION AND POST-DILATATION WAS PERFORMED WITH THE 7X40MM ARMADA BDC TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923760 ↗
• InjuryNov 25, 2019Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN A HEAVILY CALCIFIED AND MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 7.0 X 20 MM ARMADA 35 BALLOON CATHETER WAS USED TO POST-DILATE (PAST ITS RATED BURST PRESSURE) AN UNSPECIFIED SELF-EXPANDING STENT AS IT WAS STENOSED. THE PRESSURE/ATMOSPHERES WAS REPORTEDLY UNKNOWN. THE BALLOON RUPTURED AND IT WAS THEN NOT POSSIBLE TO WITHDRAW THE DEVICE INTO THE INTRODUCER SHEATH DURING REMOVAL. THEREFORE, A CUT-DOWN PROCEDURE WAS PERFORMED TO REMOVE BOTH THE DEVICE AND THE INTRODUCER SHEATH. THE FEMORAL ARTERY WAS THEN SURGICALLY CLOSED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369137 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED ILIAC ARTERY. AFTER ADVANCEMENT WITHOUT RESISTANCE, THE BALLOON OF A 7X20MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED DUE TO CALCIFICATION AFTER TWO INFLATIONS AT 15 ATMOSPHERES. THE PTA CATHETER WAS REMOVED FROM THE PATIENT ANATOMY WITH NO COMPLICATIONS AND REPLACED WITH AN UNSPECIFIED BALLOON CATHETER 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 8713323 ↗
• MalfunctionApr 30, 2018Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS AND MILDLY CALCIFIED LESION LOCATED IN THE RENAL ARTERY. A 7.0 X 20 MM ARMADA 35 BALLOON CATHETER COULD NOT ADVANCE OVER AN UNSPECIFIED GUIDE WIRE AS RESISTANCE WAS FELT THROUGH A 6FR INTRODUCER SHEATH. RESISTANCE WAS MET DURING THE REMOVAL OF THE BALLOON CATHETER FROM THE GUIDE WIRE. THE GUIDE WIRE REMAINED IN THE PATIENT AND A 4FR BALLOON CATHETER WAS SUCCESSFULLY ADVANCED OVER THE GUIDE WIRE INSTEAD TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473048 ↗