Armada B2090-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648155482), received between May 3, 2018 and Mar 27, 2024 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE LEFT FEMORAL ARTERY WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE 9X60 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND INFLATED BUT RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. A 7X80 MM ARMADA PTA CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND WAS INFLATED BUT RUPTURED AT 8 ATM DURING THE SECOND INFLATION. A THIRD ARMADA PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. 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 18987570 ↗
• MalfunctionAug 23, 2023Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY THAT IS 70% STENOSED. THE 9.0X60MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION. ANOTHER ARMADA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17605328 ↗
• MalfunctionMay 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED RIGHT COMMON ILIAC ARTERY. A 6.0X60MM AND A 6.0X40MM ARMADA 35 BALLOON WERE ATTEMPTED TO PRE-DILATE THE LESION; HOWEVER, BOTH BALLOONS REPORTEDLY RUPTURED AT 4 ATMOSPHERES (ATM). BOTH DEVICES WERE REMOVED WITHOUT ISSUE AND A 7.0X59MM OMNILINK STENT WAS IMPLANTED AND A 9.0X60MM ARMADA'S 35 WAS ATTEMPTED TO POST DILATE, BUT RUPTURED AT 6 ATM. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886413 ↗
• InjuryJun 27, 2018Detachment Of Device Component

  IT WAS REPORTED THAT THE 9.0X60 MM ARMADA 35 WAS SUCCESSFULLY USED AT THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY. DURING REMOVAL OF THE ARMADA FROM THE ANATOMY, THE BALLOON SEPARATED IN THE PATIENT. THE SEPARATED SEGMENT WAS SUCCESSFULLY REMOVED WITH A SNARE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7643431 ↗
• MalfunctionMay 3, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LOWER EXTREMITY. THE ARMADA 35 9/60 MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER BALLOON RUPTURED IN THE ANATOMY DURING THE SECOND INFLATION AT 11 ATMOSPHERES. THE ARMADA WAS REPLACED WITH ANOTHER ABBOTT BALLOON DILATATION CATHETER TO COMPLETE THE PROCEDURE. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE WITH THE CATHETER FLUSHED WITH HEPARINIZED SALINE, NEGATIVE PRESSURE APPLIED TO THE BALLOON TO DRAW OUT AIR BEFORE INSERTION OF DEVICE WITH NO ISSUES FOUND. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7484765 ↗