Armada B2120-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648155567), received between Mar 27, 2021 and Mar 30, 2026 — classified as 1 injury, 5 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.

• MalfunctionMar 30, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A RESTENOSIS, MODERATELY CALCIFIED, HEAVILY TORTUOUS ATRIOVENTRICULAR FISTULA THAT IS 90% STENOSED. THE 12.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS INFLATED THE FIRST TIME TO 8 ATMOSPHERES (ATM); HOWEVER THE BALLOON RUPTURED. A NEW 12.0X60MM ARMADA 35 BDC 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 24712575 ↗
• MalfunctionMay 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MODERATELY CALCIFIED RIGHT ILIAC ARTERY. THE 12.0X60MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT ISSUE. A SAME SIZE ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358165 ↗
• MalfunctionAug 21, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE 12X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) YELLOW PROTECTIVE SHEATH COULD NOT BE REMOVED FROM THE DEVICE. ANOTHER UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17586091 ↗
• MalfunctionMar 8, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED WITH A LEFT ILIAC VEIN, 100% RESTENOSED LESION THAT HAD BEEN PREVIOUSLY TREATED WITH AN UNSPECIFIED STENT. BALLOON ANGIOPLASTY WAS SUCCESSFULLY PERFORMED USING TWO ARMADA 35 CATHETERS. TWO ADDITIONAL ARMADA CATHETERS WERE SUCCESSFULLY ADVANCED. BOTH DEVICE BALLOONS HAD RUPTURED BELOW RATED BURST PRESSURE. THE RUPTURES WERE SUSPECTED DUE TO THE PREVIOUSLY IMPLANTED STENT STRUTS OF THE UNSPECIFIED STENT. THE DEVICES WERE SUCCESSFULLY WITHDRAWN. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13698898 ↗
• MalfunctionMar 8, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED WITH A LEFT ILIAC VEIN, 100% RESTENOSED LESION THAT HAD BEEN PREVIOUSLY TREATED WITH AN UNSPECIFIED STENT. BALLOON ANGIOPLASTY WAS SUCCESSFULLY PERFORMED USING TWO ARMADA 35 CATHETERS. TWO ADDITIONAL ARMADA CATHETERS WERE SUCCESSFULLY ADVANCED. BOTH DEVICE BALLOONS HAD RUPTURED BELOW RATED BURST PRESSURE. THE RUPTURES WERE SUSPECTED DUE TO THE PREVIOUSLY IMPLANTED STENT STRUTS OF THE UNSPECIFIED STENT. THE DEVICES WERE SUCCESSFULLY WITHDRAWN. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13698725 ↗
• InjuryMar 27, 2021Entrapment of Device; Material Rupture; Material Separation; Entrapment of Device; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A COMMON ILIAC ARTERY. A 12X40MM ARMADA 35 BALLOON WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. ONCE AT THE LESION, THE BALLOON WAS INFLATED ONCE AT 3-4 ATMOSPHERES (ATM) AND RUPTURED CIRCUMFERENTIALLY. THE DEVICE WAS WITHDRAWN WITHOUT ISSUE. THEN A 12X60MM ARMADA 35 BALLOON WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. ONCE AT THE LESION, THE BALLOON WAS INFLATED ONCE AT 3-4 ATMOSPHERES (ATM) AND RUPTURED CIRCUMFERENTIALLY. THE DEVICE WAS ATTEMPTED TO BE REMOVED BUT MET RESISTANCE WITH THE ANATOMY AND COULD NOT BE REMOVED COMPLETELY. THEREFORE SURGICAL INTERVENTION WAS PERFORMED TO SUCCESSFULLY REMOVE THE DEVICE. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11578883 ↗