Armada B1070-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648154812), received between Apr 20, 2018 and Jul 7, 2025 — classified as 4 injuries, 2 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.

• InjuryJul 7, 2025Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED LEFT COMMON ILIAC ARTERY. THE 7.0X100MM ARMADA 35 BALLOON DILATATION CATHETER WAS INFLATED ONCE TO 8 ATMOSPHERES, THE BALLOON RUPTURED AND SEPARATED ALONG ITS LENGTH IN TWO PIECES. THE ARMADA 35 BALLOON WAS SURGICALLY REMOVED. THERE WAS NO ADVERSE PATIENT SEQUELA; HOWEVER, CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22415456 ↗
• InjuryOct 30, 2024Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HIGHLY STENOSED COMMON FEMORAL ARTERY (CFA) TO PROSTHETIC GRAFT INTERPOSITION AUTOGENOUS VEIN GRAFT. THE 7X100MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS USED THE PROCEDURE FOR POST DILATATION OF A COVERED STENT; HOWEVER THE BALLOON RUPTURED BELOW RATED BURST PRESSURE (RBP). THE BALLOON WAS INFLATED JUST ABOVE NOMINAL PRESSURE ONE TIME. FRAGMENTS OF THE BALLOON EMBOLIZED IN THE COMMON AND EXTERNAL ILIAC ARTERIES; THEREFORE, FOUR COVERED STENTS WERE USED TO JAIL THE BALLOON FRAGMENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Embolism/Embolus

  MAUDE report 20570569 ↗
• MalfunctionJun 1, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UPON OPENING OF THE 7X100MM 35 ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, IT WAS NOTED THAT THE BALLOON HAD A SIZE OF 7.0X120MM THAT WAS DIFFERENT THAN THE LABELED. ANOTHER UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, 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 17039449 ↗
• InjuryFeb 27, 2023Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO OPEN A POOR QUALITY CALCIFIED SHUNT IN THE LEFT UPPER ARM, THE ARMADA BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION; HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED CIRCUMFERENTIALLY. RESISTANCE WITH THE SHEATH WAS NOTED DURING REMOVAL AND ONCE REMOVED, IT WAS NOTED THAT ONLY A PART OF THE BALLOON WAS REMOVED WITH THE DEVICE. THE REST OF THE BALLOON REMAINED IN THE SHUNT AS THE SHUNT WAS NOTED TO BE OCCLUDED AND NO LONGER USABLE FOR DIALYSIS. THERE WAS NO ADDITIONAL INTERVENTION TO THE SHUNT. SOMETHING ELSE WAS DONE FOR THE PATIENT TO ENABLE DIALYSIS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 16448673 ↗
• MalfunctionMar 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE ARMADA 35 DILATATION CATHETER WAS PREPARED FOR USE AND NO ISSUES WERE NOTED. THE ARMADA 35 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION AND INFLATED; HOWEVER, ON THE SECOND INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERES (ATM). A NON-ABBOTT DILATATION CATHETER WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13906130 ↗
• InjuryApr 20, 2018Detachment Of Device Component; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID FEMORAL ARTERY THAT WAS MILDLY TORTUOUS, HEAVILY CALCIFIED AND 80% STENOSED. THE ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER WAS ADVANCED WITH SUCCESS HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES DUE TO EXCESSIVE CALCIFICATION IN THE TREATMENT AREA. DURING REMOVAL OF THE DELIVERY SYSTEM WITH SLIGHT RESISTANCE, IT WAS OBSERVED THAT 80 CM CAME OUT OF THE SHEATH IN THE PATIENT AND THE PROXIMAL 10-12 CM OF THE SYSTEM WAS STILL IN CROSSOVER POSITION IN THE TREATED AREA. THE DELIVERY SYSTEM BROKE IN TWO PIECES IN THE PATIENT. A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED SEGMENT. THIS WAS DONE WITH SUCCESS AND NO ADVERSE PATIENT EFFECTS AND IT WAS CONFIRMED NOTHING WAS LEFT IN THE PATIENT. THERE WAS A CLINICALLY SIGNIFICANT DELAY OF 90 MINUTES AND AN EXTRA 5000 UNITS OF HEPARIN WAS GIVEN TO PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7447182 ↗