Armada B1090-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648154904), received between Sep 15, 2016 and Jan 19, 2026 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A RESTENOSED, HEAVILY CALCIFIED, HEAVILY TORTUOUS ARTERIOVENOUS ANASTOMOSIS THAT IS 80% STENOSED. ONCE AT THE LESION, THE 9.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. A NEW 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 24109389 ↗
• InjuryFeb 24, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE COMMON FEMORAL ARTERY. THE 9.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING INFLATION THE BALLOON RUPTURED AT 6 ATMOSPHERES AND SEPARATED. ANOTHER PUNCTURE WAS MADE TO ACCESS THE LESION WITH A NEW LARGER INTRODUCER AND THE SEPARATED PORTIONS OF THE BALLOON WERE RETRIEVED WITH A SNARE DEVICE. THE PATIENT REQUIRED FURTHER HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446206 ↗
• InjuryDec 18, 2024Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: IT WAS STATED THE PROCEDURE WAS A LAPAROSCOPIC CUT. THE PATIENT IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20970897 ↗
• MalfunctionDec 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS ILIAC ARTERY THAT IS 70% STENOSED. THE 9.0X40MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED AT 3 ATMOSPHERES DURING THE FIRST INFLATION. NO OTHER DEVICE WAS NEEDED TO COMPLETE THE PROCEDURE. 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 20926560 ↗
• MalfunctionMay 20, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESS THAN 50% STENOSED LESION IN THE ILIAC ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 9X40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND WHEN THE BALLOON WAS ATTEMPTED TO BE INFLATED AT THE TARGET LESION THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 9.5 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED IN TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355211 ↗
• InjuryApr 30, 2024Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT COMMON ILIAC ARTERY. A 9X30MM SHOCKWAVE BALLOON WAS USED TO PRE-DILATE THE LESION. HOWEVER, A 9X40MM ARMADA 35 BALLOON WAS ATTEMPTED TO FURTHER DILATE THE LESION, BUT RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. DURING REMOVAL THE BALLOON MET RESISTANCE WITH A 7FR SHEATH AND THE ENTIRE BALLOON COULD NOT BE PULLED BACK IN. THEREFORE, A NEW 7FR SHEATH WAS INSERTED AND AT THE SHAFT THE PHYSICIAN WAS ABLE TO CUT THE BALLOON, SNARE THE DISTAL END WITH THE 7FR SHEATH AND SIMPLY WITHDRAW THE PROXIMAL PORTION. AN 8FR SHEATH WAS INSERTED AND AN UNSPECIFIED STENT WAS USED TO TREAT THE RIGHT COMMON ILIAC ARTERY. A PRECLOSE DEVICE WAS INSERTED AND OPEN THE FOOT, PULLED BACK AND SAW BLOOD. THE FOOT WAS PUT DOWN AND WAS NOT DEPLOYED. ACHIEVED HEMOSTASIS WITH A 7.0X29 NON-ABBOTT COVERED STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215408 ↗
• MalfunctionSep 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 9X40MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, NEGATIVE PRESSURE WAS BEING APPLIED WITH AN INDEFLATOR WHEN A LARGE AMOUNT OF AIR WAS SUCKED IN. THE BALLOON WAS NOTED RUPTURED FROM THE BEGINNING. ANOTHER ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT, 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 17782855 ↗
• MalfunctionAug 31, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE ILIAC ARTERY. AFTER SUCCESSFUL IMPLANTATION OF AN 8X39 OMNILINK STENT, A 9X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO POST-DILATE THE STENT. DURING THE FIRST INFLATION TO 8 ATMOSPHERES, THE BALLOON RUPTURED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331377 ↗
• MalfunctionOct 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE RIGHT ILIAC ARTERY THAT WAS HEAVILY CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED. THE ARMADA 35 BALLOON RUPTURED DURING THE SECOND INFLATION AT 9 ATMOSPHERES. ANOTHER SAME SIZE ARMADA WAS USED TO COMPLETE 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 12677277 ↗
• MalfunctionMar 16, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEPATIC VEIN. A 9.0 X 40 MM ARMADA 35 BALLOON WAS PREPPED WITHOUT ANY ISSUES AND ADVANCED WITHOUT RESISTANCE; HOWEVER, THE BALLOON RUPTURED DURING FIRST INFLATION AT 4 ATMOSPHERES. THE ARMADA 35 WAS REMOVED, AND A NEW UNSPECIFIED BALLOON 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 11495419 ↗
• MalfunctionJun 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE RIGHT COMMON AND EXTERNAL ILIAC ARTERIES. ANGIOPLASTY WAS PERFORMED WITH A 9X40MM ARMADA 35 BALLOON, RESULTING IN SATISFACTORY RESOLUTION OF THE STENOSIS AND BRISK FLOW, BUT THE BALLOON RUPTURED AFTER THE SECOND INFLATION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10155948 ↗
• InjuryJul 11, 2019Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY PROCEDURE TO TREAT A HEAVILY CALCIFIED AND NON-TORTUOUS LESION IN AN UNSPECIFIED VESSEL. A 9.0X40MM ARMADA BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT 11 ATMOSPHERES. THE BALLOON AND TIP SEPARATED FROM THE SHAFT WHEN ATTEMPTED TO BE PULLED BACK INTO THE SHEATH. ONE OF THE RADIOPAQUE MARKERS CAME OUT OF THE SHEATH WHEN FLUSHED OUT; HOWEVER, THE TIP COULD NOT BE LOCATED. IT IS UNKNOWN IF THE TIP IS LODGED IN THE SHEATH OR IF IT IS INSIDE THE PATIENT, THE REST OF THE BDC WAS REMOVED FROM THE ANATOMY. A NEW SHEATH WAS INSERTED AND ANOTHER UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. PEDAL PULSES WERE CHECKED AND PULSES WERE PALPABLE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8783119 ↗
• MalfunctionMay 25, 2018Inflation Problem; Material Rupture; Folded

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, MILDLY CALCIFIED, 99% STENOSED LESION IN THE FEMORAL ARTERY. A 9 X 40MM ARMADA 35 WAS ADVANCED INTO THE PATIENT ANATOMY AND FAILED TO INFLATE. THE BALLOON WAS NOTED TO BE TWISTED ON ITSELF ONCE IT WAS REMOVED FROM THE PATIENT ANATOMY. A NEW ARMADA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE RETURN DEVICE ANALYSIS FOUND THAT THERE WAS A LONGITUDINAL RUPTURE AT THE DISTAL BALLOON SHOULDER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7545531 ↗
• MalfunctionMay 3, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT COMMON ILIAC WITH MODERATE CALCIFICATION. THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS SUCCESSFULLY TREATED WITH A STENT IMPLANT PRIOR TO TREATING THE LEFT COMMON ILIAC. PRE-DILATATION WAS NOT PERFORMED INITIALLY TO TREAT THE ILIAC. RESISTANCE WAS FELT DURING THE ADVANCEMENT OF THE 8 X 39 MM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) AND THE SDS WOULD NOT CROSS THE LESION. PRE-DILATATION WAS PERFORMED USING A 7 X 60 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC). RESISTANCE WAS NOT FELT DURING THE ADVANCEMENT OF THE BDC; HOWEVER, THE BALLOON RUPTURE DURING THE FIRST INFLATION BETWEEN 3 TO 4 ATMOSPHERES. RESISTANCE WAS NOT FELT AS A SECOND 7 X 40 MM ARMADA 35 BDC WAS ADVANCED TO THE LESION FOR PRE-DILATATION; HOWEVER, IT RUPTURED DURING THE FIRST INFLATION BETWEEN 3 TO 4 ATMOSPHERES. A NON-ABBOTT BDC WAS THEN ADVANCED TO THE LESION AND RUPTURED DURING INFLATION. PRE-DILATATION WAS SUCCESSFULLY PERFORMED USING A SECOND NON-ABBOTT BDC WHICH INFLATED WITHOUT ISSUES. THE PREVIOUSLY USED OMINLINK ELITE WAS ADVANCE TO THE LESION WITHOUT RESISTANCE AND WAS SUCCESSFULLY DEPLOYED. POST-DILATATION WAS PERFORMED USING A 9

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6541079 ↗
• MalfunctionSep 15, 2016Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY STENOSED VENUS AV FISTULA OF THE ARM. A 9 X 40 MM ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE AND INFLATED TO 13 ATMOSPHERES; HOWEVER, THE BALLOON WOULD NOT INFLATE FULLY. THERE WAS A WAIST IN THE BALLOON. A NON-ABBOTT 8 X 40 MM BALLOON CATHETER WAS SUCCESSFULLY USED 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 5954010 ↗