Armada B1040-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648154515), received between Dec 21, 2016 and Dec 22, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AIR BUBBLES WERE NOTED ON THE INDEFLATOR DURING AIR ASPIRATION OF THE ARMADA 35. THE USER TRIED THE AIR ASPIRATION WITH A NORMAL SYRINGE AND THE SAME ISSUE PERSISTED; AIR WAS NOTED ON THE SYRINGE DURING AIR ASPIRATION OF THE ARMADA 35. THIS DEVICE WAS NOT USED IN THE PATIENT. ANOTHER ARMADA BALLOON 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 23865798 ↗
• MalfunctionNov 17, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF A 4.00X40MM ARMADA 35 BALLOON DILATATION CATHETER, A LEAK WAS NOTED. THERE WAS NO DEVICE USE OR 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 23573782 ↗
• MalfunctionNov 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  SUBSEQUENTLY AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, RETURNED DEVICE ANALYSIS OBSERVED THAT THE BALLOON CATHETER INFLATED AND MAINTAINED PRESSURE. THERE WAS NO HOLE AS REPORTED ON THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534562 ↗
• MalfunctionMar 25, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. USING THE IPSILATERAL ANTEGRADE APPROACH THROUGH A 6FR SHORT SHEATH ON A .035 GUIDEWIRE, THE 4X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689313 ↗
• MalfunctionDec 12, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE COMMON ILIAC ARTERY. AFTER A 4X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER THE INSTRUCTIONS FOR USE, IT WAS ADVANCED THROUGH RESISTANCE AND ATTEMPTED TO BE USED FOR VESSEL DILATION; HOWEVER, DURING THE SECOND INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 10ATMS. THE BDC WAS REMOVED AND REPLACED WITH A NON-ABBOTT BDC TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913232 ↗
• MalfunctionDec 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH A ATRIOVENTRICULAR FISTULA (AV) WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 60% STENOSIS. AN ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED, NOT REACHED BURST PRESSURE WHEN A RUPTURE OCCURRED. THE BDC WAS REMOVED, ANOTHER ARMADA 35 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 15988085 ↗
• MalfunctionJun 28, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 4X40MM ARMADA 35, IT WAS NOTED THAT CONTRAST WAS LEAKING FROM THE BALLOON. THE DEVICE WAS NOT USED. 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 14848125 ↗
• MalfunctionFeb 24, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS ATRIOVENTRICULAR (AV) FISTULA. THE 4.00X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER FAILED TO INFLATE AND WAS LOSING PRESSURE WHEN ATTEMPTING TO INFLATE. AFTER IT WAS REMOVED, IT WAS FOUND THAT THE BALLOON LEAKED AIR BUT THE SOURCE COULD NOT BE FOUND. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376330 ↗
• MalfunctionDec 23, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF A 4X40MM ARMADA 35 BALLOON CATHETER NEGATIVE PRESSURE WAS APPLIED AND A SUCKING SOUND COULD BE HEARD; IT WAS DETERMINED THAT THE BALLOON HAD A PERFORATION. THE BALLOON CATHETER WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 11069756 ↗
• MalfunctionOct 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN 80% STENOSED, MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE ARTERIOVENOUS FISTULA. A 4X40MM ARMADA 35 BALLOON CATHETER RUPTURED DURING THE FIRST INFLATION UNDER RATED BURST PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 4X40MM ARMADA 35 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 9181110 ↗
• MalfunctionDec 21, 2016Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE CALCIFIED, ARTERIOVENOUS (AV) SHUNT A BALLOON RUPTURE OCCURRED AT RATED BURST PRESSURE (RBP). THE DEVICE WAS REMOVED AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 6197339 ↗