Armada B2050-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648155208), received between Mar 9, 2017 and Nov 8, 2024 — classified as 1 injury, 9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION. THE 5X100MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE BDC BECAME STUCK WITH ON A NON-ABBOTT GUIDE WIRE (GW). THE BDC AND THE GW HAS TO BE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER ARMADA BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642398 ↗
• MalfunctionNov 5, 2024Inflation Problem; Improper or Incorrect Procedure or Method; Inflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE SUPERFICIAL FEMORAL ARTERY WITH MILD TORTUOSITY, MILD CALCIFICATION AND 90% STENOSIS. THE 5.0X100MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS NOT PREPPED PER IFU AND ADVANCED OVER AN UNSPECIFIED 0.035 GUIDE WIRE. THE BALLOON WAS ATTEMPTED TO BE INFLATED YET THE BALLOON DID NOT INFLATE AS CONFIRMED BY ANGIOGRAM. A NON-ABBOTT 5X100MM BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE DEVICE LEAKED FROM THE HUB DURING TESTING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616058 ↗
• MalfunctionFeb 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION (MI). THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED, DE NOVO LESION IN THE LESION IN THE RIGHT SUPERIOR FEMORAL ARTERY (SFA). A 5.0X100MM ON 135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) BALLOON WAS ADVANCED TO THE LESION BUT RUPTURED BEFORE REACHING NOMINAL PRESSURE DURING THE FIRST INFLATION. A 5.0X150MM 135CM ARMADA 35 BDC WAS USED TO CONTINUE THE PROCEDURE. A 6.0X200MM ON 135CM ARMADA 35 BDC BALLOON WAS ADVANCED TO THE LESION BUT RUPTURED BEFORE REACHING NOMINAL PRESSURE DURING THE FIRST INFLATION. A 6.0X100MM 150CM NON-ABBOTT DEVICE WAS USED TO CONTINUE THE PROCEDURE. A 2.0X200MM ON 150CM ARMADA 14 BDC WAS ADVANCED, BUT THE BALLOON TIP AND DISTAL SHAFT BECAME STUCK IN THE VESSEL WHILE PULLING BACK THE BALLOON AND SEPARATED. THE PLAN WAS TO SCHEDULE A RETRIEVAL OF THE SEPARATED DEVICE THAT REMAINED IN THE PATIENT, THE NEXT DAY, BUT DUE TO CATH LAB AVAILABILITY, IT WAS POSTPONED ONE MORE DAY. THE PATIENT PASSED AWAY ON THE SECOND DAY AFTER THE ANGIOPLASTY PROCEDURE DUE TO THE EFFECTS OF THE MI. IN THE PHYSICIAN'S OPINION, THE DEATH AND MI, WERE NOT RELATED TO ANY OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440450 ↗
• InjuryJun 26, 2022Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED VESSEL IN THE LEFT EXTERNAL ILIAC ARTERY. THE 5.0X100MM ARMADA 35 BALLOON CATHETER WAS PREPARED AND HAD SLIGHT RESISTANCE WITH THE ANATOMY BUT WAS ADVANCED TO THE LESION. HOWEVER, AT FIRST INFLATION WITH A PRESSURE OF 8 ATMOSPHERES (ATMS) THE BALLOON BECAME STUCK WITH THE CALCIFICATION AND RUPTURED. THE BALLOON WAS FULLY DEFLATED UPON REMOVAL. RESISTANCE WAS NOTED UPON WITHDRAWAL AND MORE FORCE APPLIED TO REMOVE THE BALLOON CATHETER. THE BALLOON SEPARATED ON THE GUIDE WIRE BUT THE SEPARATED PIECES AND THE GUIDE WIRE WERE ALL REMOVED AS A SINGLE UNIT. DURING REMOVAL, THE ATRIOTOMY RIPPED AND CUTDOWN WAS PERFORMED TO PATCH IT. NOTHING WAS LEFT IN THE PATIENT'S ANATOMY. ANOTHER DEVICE 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; Unspecified Tissue Injury

  MAUDE report 14824127 ↗
• MalfunctionJun 21, 2021Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE ARMADA 35 BALLOON CATHETER WAS UNABLE TO DEFLATE. THERE WAS 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 12036766 ↗
• MalfunctionSep 9, 2020Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING ARMADA PREPARATION PER INSTRUCTION FOR USE, NEGATIVE PRESSURE WAS PULLED WHEN A BALLOON PINHOLE WITH A LEAK WERE OBSERVED. THERE WAS NO PATIENT INVOLVEMENT AND THE DEVICE WAS NOT USED IN A PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS DEVICE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 10512449 ↗
• MalfunctionAug 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. AN UNSPECIFIED STENT WAS IMPLANTED AND THE ARMADA 35 DILATATION CATHETER BALLOON WAS USED FOR POST-DILATATION. DURING USE, THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. A SECOND SAME DEVICE WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10417889 ↗
• MalfunctionSep 13, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE ARMADA 35 DILATATION CATHETER WAS ADVANCED OVER A NON-ABBOTT GUIDE WIRE. RESISTANCE WAS NOTED DURING ADVANCEMENT, AND THE ARMADA 35 WAS NEVER ABLE TO ENTER THE SHEATH OR ANATOMY. THE DECISION WAS MADE TO REMOVE THE ARMADA 35 DILATATION CATHETER. SOME RESISTANCE WAS NOTED DURING REMOVAL; HOWEVER, THE GUIDE WIRE REMAINED IN THE ANATOMY. A SECOND SAME SIZE ARMADA 35 WAS ADVANCED OVER THE SAME GUIDE WIRE AND NO RESISTANCE WAS NOTED. 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 9048749 ↗
• MalfunctionOct 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED TO THE LESION WITH NO RESISTANCE; HOWEVER, THE BALLOON RUPTURED ON THE SECOND INFLATION AT 14 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ADDITIONAL UNSPECIFIED BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985134 ↗
• MalfunctionMar 9, 2017Leak/Splash

  IT WAS REPORTED THAT THE 5X100 ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE MILDLY CALCIFIED, MILDLY TORTUOUS ILIAC ARTERY AND INFLATED TO 8 ATMOSPHERES WHEN A LEAK WAS NOTED ON THE CATHETER. THE BDC WAS REMOVED AND REPLACED WITH ANOTHER ARMADA 35 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 Consequences Or Impact To Patient

  MAUDE report 6393523 ↗