Armada B2050-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648155239), received between Nov 17, 2016 and May 19, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Leak/Splash; Deformation Due to Compressive Stress; Leak/Splash; Deformation Due to Compressive Stress

  T WAS REPORTED THAT DURING PREPARATION OF THE 5X200 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, THE BALLOON WAS NOTED TO HAVE A PINHOLE AND A SMALL KINK IN THE BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW, SAME SIZE ARMADA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046897 ↗
• MalfunctionJan 16, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE SUPERFICIAL FEMORAL ARTERY WITH MILD TORTUOSITY, MODERATE CALCIFICATION AND 80% STENOSIS. THE 5.0X200MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND ADVANCED TO THE LESION. THE BALLOON WAS INFLATED ONCE TO 5 ATMOSPHERES YET WAS UNABLE TO HOLD PRESSURE THUS UNABLE TO INFLATE. A LEAK WAS NOTED AT THE CONNECTION BETWEEN THE DEVICE AND THE PUMP. THEREFORE, ANOTHER SAME SIZE DEVICE WAS USED TO 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 21170715 ↗
• MalfunctionNov 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH 95 STENOSIS, HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 5.0X200MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND ADVANCED WITHOUT RESISTANCE, HOWEVER, RUPTURED AT NOMINAL PRESSURE DURING THE FIRST INFLATION. A 5.0X100MM ARMADA 35 BDC WAS USED AND A SUPERA SELF-EXPANDING STENT (SES) WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709030 ↗
• MalfunctionSep 27, 2021Difficult 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 PERFORMED TO TREAT A DE NOVO LESION IN THE HEAVILY CALCIFIED, MODERATELY TORTUOUS, 80% STENOSED LEFT SUPERFICIAL FEMORAL ARTERY. A NON-ABBOTT 6F SHEATH WAS ADVANCED WITH A 5X200MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT NOMINAL PRESSURE. THE PTA CATHETER AND SHEATH FACED RESISTANCE WITH EACH OTHER DURING REMOVAL, SO FORCE WAS APPLIED. AN UNSPECIFIED ARMADA 35 BALLOON 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 12533887 ↗
• MalfunctionFeb 19, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THREE ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS (5X200MM, 5X20MM, 6X200MM) AND TWO ABSOLUTE PRO SELF-EXPANDING STENT SYSTEMS (SESS) (6X150MM, 6X60MM) WERE RECEIVED BY THE CUSTOMER WITH BLOOD MARKS ON THE OUTSIDE PACKAGING. THE DEVICES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9727218 ↗
• MalfunctionMay 18, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY THAT WAS MILDLY TORTUOUS, HIGHLY CALCIFIED AND 60% STENOSED. THE ARMADA 35 BALLOON BURST AFTER THE FIRST INFLATION BELOW RATED BURST PRESSURE. ANOTHER ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE WITH NO ISSUES OR LEAKS NOTED. 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 6575589 ↗
• MalfunctionNov 17, 2016Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5 X 200 MM ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE LESION FOR PRE-DILATATION: HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION BELOW THE RATED BURST PRESSURE. IT IS UNKNOWN EXACTLY WHAT PRESSURE. ANOTHER ARMADA BALLOON CATHETER WAS USED FOR PRE-DILATATION AND AN UNKNOWN STENT WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6110472 ↗