Armada B2050-250Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648155246), received between May 2, 2017 and Oct 26, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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.

• MalfunctionOct 26, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 5X250 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, AIR GOT INTO THE IDEFLATOR WHEN THE BALLOON WAS PULLED NEGATIVE. THE ARMADA PTA CATHETER WAS NEVER USED INSIDE THE PATIENT. ANOTHER UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO 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 12699326 ↗
• MalfunctionJul 21, 2021Inflation Problem; Leak/Splash; Difficult to Advance; Inflation Problem; Leak/Splash; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 5X250MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER FACED RESISTANCE WITH A NON-ABBOTT GUIDE WIRE AND NON-ABBOTT GUIDING CATHETER DURING ADVANCEMENT. THE PTA BALLOON FAILED TO INFLATE, AND THE DEVICE FAILED TO HOLD PRESSURE. NO TEAR WAS NOTED. A 5X200MM ARMADA WAS USED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12204072 ↗
• MalfunctionMay 19, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY THAT WAS NON-CALCIFIED AND NON-TORTUOUS. THE ARMADA 35 LL WAS PREPPED PER THE INSTRUCTIONS FOR USE. THE BALLOON WAS INFLATED ONCE TO NOMINAL PRESSURE AND DEFLATED WITHOUT ISSUE, HOWEVER THE BALLOON FUSED TO THE .035 NON-ABBOTT GUIDE WIRE AND THE GUIDE WIRE AND DELIVERY SYSTEM HAD TO BE REMOVED AS REMOVED AS A UNIT. THERE WERE NO REPORTED 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 11849458 ↗
• MalfunctionJul 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. FOLLOWING ATHERECTOMY, A 5X250MM ARMADA 35 BALLOON CATHETER WAS BEING USED FOR POST-DILATATION; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED BALLOON CATHETER. 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 10333408 ↗
• MalfunctionMay 2, 2017Break

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF THE 5 X 250 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) THE STRAIN RELIEF FELT LOOSE. THE DEVICE WAS NOT USED IN THE PATIENT AND THERE WAS NO PATIENT INVOLVEMENT. A NEW BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6538289 ↗