Armada B1120-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648154997), received between Nov 21, 2016 and Aug 11, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A RIGHT AUXILIARY TO SUBCLAVIAN FISTULA. THE 12X60MM ARMADA 35 BALLOON CATHETER WAS ADVANCED WITHOUT RESISTANCE; HOWEVER, THE BALLOON RUPTURED AT 4 ATMOSPHERES DURING THE FIRST INFLATION. WHEN REMOVING THE BALLOON CATHETER RESISTANCE WITH THE ANATOMY WAS FELT AND THE BALLOON RIPPED IN HALF; BUT STAYED ATTACHED WHERE THE MARKERS ARE AND WAS REMOVED FROM THE PATIENT AS ONE UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT BALLOON CATHETER. 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 22772651 ↗
• MalfunctionFeb 13, 2025Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUBCLAVIAN ARTERY. AFTER A 12X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO REPORTED ISSUES, IT WAS ATTEMPTED TO BE USED FOR VESSEL DILATATION; HOWEVER, THE BALLOON WAS NOTED TO RUPTURE DURING THE FIRST INFLATION AT APPROXIMATELY 3-4 ATMOSPHERES. THE RUPTURED BDC AND SHEATH WERE REMOVED AS A SINGLE UNIT AS THE BALLOON HAD WRAPPED AROUND THE SHEATH WHEN IT RUPTURED. A NEW ARMADA WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION AS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375454 ↗
• MalfunctionMay 15, 2024Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT AN UNSPECIFIED ARMADA BALLOON BASTED (RUPTURED) AND WHEN PULLED THE BALLOON SEPARATED. THE SEPARATED PORTION WAS NOTED TO BE MISSING IN THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321484 ↗
• MalfunctionNov 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LOWER EXTREMITY. THE 12.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND INFLATED AT AN UNKNOWN PRESSURE BUT BURST BEFORE REACHING NOMINAL PRESSURE. ANOTHER ABBOTT BALLOON WAS USED 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 18074211 ↗
• MalfunctionJul 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY STENOSED AND MODERATELY TORTUOUS LESION IN THE RIGHT INNOMINATE VEIN. THE 12X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET VEIN WITH NO RESISTANCE NOTED. DURING THE FIRST INFLATION, THE BALLOON RUPTURE AT 4 ATMOSPHERES (ATM). THE BDC WAS REMOVED WITHOUT RESISTANCE NOTED. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT BALLOON CATHETER. 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 17430665 ↗
• MalfunctionOct 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 12X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED AT A LOW PRESSURE. ANOTHER BALLOON WAS USED 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 15587221 ↗
• MalfunctionOct 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT COMMON ILIAC VEIN. THE ARMADA BALLOON WAS BEING USED FOR POST DILATATION OF A STENT BUT RUPTURED DURING THE 1ST INFLATION AT TWO ATMOSPHERES. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. 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 12700899 ↗
• MalfunctionMar 24, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 11562206 ↗
• MalfunctionMar 26, 2020Break; Peeled/Delaminated; Difficult to Remove; Break; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE ILIAC ARTERY. THE 12MM X 60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), WAS USED WITHOUT ISSUE; HOWEVER, DURING REMOVAL, RESISTANCE WAS FELT WITH THE 6F NON-ABBOTT INTRODUCER SHEATH. THE BALLOON SHREDDED INSIDE OF THE INTRODUCER SHEATH AND THE TIP OF THE CATHETER BROKE BUT DID NOT SEPARATE IN TWO PIECES. THE PROCEDURE WAS COMPLETE AT THIS TIME, THE BDC AND INTRODUCER SHEATH WERE REMOVED AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9885018 ↗
• InjuryOct 19, 2018Off-Label Use; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Off-Label Use; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE SEVERELY STENOSED CEPHALIC VEIN USING A RADIAL VENOUS ACCESS, THE 12 X 60 MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS BEING INFLATED. DURING THE FIRST INFLATION ABOVE RATED BURST PRESSURE (RBP) THE BALLOON RUPTURED AND DETACHED. SEVERAL ATTEMPTS USING DIFFERENT ACCESS SITES AND SHEATH CHANGES WERE UNSUCCESSFUL; EVENTUALLY, THE BALLOON FRAGMENT WAS SNARED AND REMOVED FROM THE VEIN. ALTHOUGH THE PROCEDURE TIME WAS EXTENDED BY APPROXIMATELY 2 HOURS, THERE WAS NO CLINICAL SIGNIFICANCE TO THE PATIENT WHO REMAINED STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7986994 ↗
• MalfunctionNov 21, 2017Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE ILIAC VEIN. A 12MM X 60 MM X 80 CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 2 ATMOSPHERES. THE BDC WAS REPLACED WITH A NEW UNSPECIFIED ARMADA 35 BDC 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 7050339 ↗
• MalfunctionNov 21, 2016Material Rupture; Torn Material

  IT WAS REPORTED THAT THE ARMADA 35 WAS INFLATED TWICE IN THE FISTULA WHEN LOSS OF PRESSURE WAS NOTED AT 6 ATMOSPHERES. THE BALLOON HAD RUPTURED. AFTER REMOVAL OF THE ARMADA 35 FROM THE ANATOMY, IT WAS NOTED THAT THERE WAS A TEAR ON THE BALLOON. 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 6118070 ↗