Armada B2100-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648155512), received between Jun 27, 2018 and Nov 26, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED RIGHT COMMON ILIAC ARTERY THAT IS 90% STENOSED. A 10.0X4MM ARMADA 35 BALLOON DILATATION CATHETER WAS INSERTED THROUGH A 6F 10CM SHEATH OVER A .018 UNSPECIFIED GUIDEWIRE. ONCE AT THE TARGET SITE THE BALLOON WAS INFLATED TO NOMINAL PRESSURE; HOWEVER, THE BALLOON RUPTURED. A NEW NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY 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 23662773 ↗
• MalfunctionOct 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED LESION IN THE AV FISTULA WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 10X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO 10 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER 10X40MM ARMADA 35 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 20495743 ↗
• MalfunctionNov 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS FISTULA STENOSIS. REPORTEDLY, THE 10X40MM ARMADA 35 BALLOON CATHETER WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUES. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE CATHETER, BUT THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES. ANOTHER SAME SIZE BALLOON 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 18164757 ↗
• MalfunctionJun 8, 2023Inflation Problem; Material Rupture; Material Separation; Inflation Problem; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO A LESION IN A UNSPECIFIED ARTERY. THE 10MM/40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON FAILED TO INFLATE. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND THE BALLOON WAS INFLATED. IN ADDITION, THE BALLOON SEPARATED 2 CENTIMETERS (CM) DISTAL TO THE DISTAL SEAL. THE PROXIMAL PORTION OF THE SEPARATED BALLOON WAS MEASURED TO BE 3CM LONG FROM THE PROXIMAL SEAL. THE BALLOON MATERIAL AT THE SEPARATION WAS WRINKLED AND UNEVEN. IT APPEARS THAT PORTION OF SEPARATED BALLOON WAS NOT RETURNED WITH THE DEVICE. THERE WAS A LONGITUDINAL BALLOON RUPTURE THAT STARTED FROM ITS DISTAL END TO NOTED BALLOON SEPARATION. THERE WAS A LONGITUDINAL BALLOON RUPTURE THAT STARTED FROM ITS DISTAL END TO NOTED BALLOON SEPARATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087564 ↗
• MalfunctionDec 1, 2022Break; Break

  USER FACILITY MEDWATCH REPORT (4500440000-2022-8052) RECEIVED STATING: THE CATHETER WAS USED ON THE PATIENT AND BUSTED WHILE IN USE. THE CATHETER WAS RETRIEVED AND WAS COMPLETE ON REMOVAL. SURGEON COMMUNICATED WITH THE TEAM. SEE ATTACHED MEDWATCH FOR ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15895181 ↗
• MalfunctionNov 18, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CEPHALIC VEIN. THE10X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED AND INFLATED TO NOMINAL PRESSURE; HOWEVER, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON TO RATED BURST PRESSURE (RBP). THE BDC RUPTURED AT AN UNKNOWN PRESSURE BEFORE IT REACHED RBP AND ANOTHER UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12840020 ↗
• InjuryAug 24, 2021Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE HEAVILY CALCIFIED AORTA WITHOUT ISSUE. DURING THE FIRST INFLATION, THE BALLOON RUPTURED DUE TO THE HEAVY CALCIFICATION. DURING REMOVAL, RESISTANCE WAS NOTED AND THE BALLOON SEPARATED FROM THE BALLOON DILATATION CATHETER. A SNARE WAS USED TO RETRIEVE THE BALLOON. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362696 ↗
• InjuryJan 23, 2020Off-Label Use; Material Rupture; Material Separation; Off-Label Use; Material Rupture; Material Separation

  IT WAS REPORTED THAT AFTER ADVANCING AN ARMADA BALLOON DILATATION CATHETER TO THE HEAVILY SCARRED ABDOMINAL AORTA NEAR WHERE AN INFERIOR VENA CAVA (IVC) FILTER AND PREVIOUSLY PLACED STENTS WERE LOCATED, THE BALLOON RUPTURED DURING THE FIRST INFLATION, BELOW THE RATED BURST PRESSURE AND THE DISTAL SHAFT SEPARATED. THE SEPARATED SHAFT WAS SUCCESSFULLY SNARED AND REMOVED. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9623690 ↗
• MalfunctionSep 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS FISTULA. A 10X40MMX135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE, HOWEVER DURING THE FIRST INFLATION TO 4 ATMOSPHERES (ATM), THE BALLOON RUPTURED. A SECOND 10X40MMX135CM ARMADA 35 BDC ALSO RUPTURED AT 4 ATM. A 10X40MMX80CM ARMADA 35 BDC RUPTURED AT 6 ATM, AND A 12X40MMX80CM ARMADA 35 BDC, RUPTURED AT 4 ATM. ALTHOUGH NO DAMAGE WAS SEEN ON THE INDEFLATOR, IT WAS STATED THERE COULD BE AN ISSUE WITH THE INDEFLATOR, SINCE THE FOUR BALLOONS RUPTURED DURING INFLATION WITH THE SAME INDEFLATOR. A NEW INDEFLATOR AND AN UNSPECIFIED BDC WERE USED WITHOUT FURTHER ISSUES TO COMPLETE THE PROCEDURE. 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 7847445 ↗
• MalfunctionSep 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS FISTULA . A 10X40MMX135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE, HOWEVER DURING THE FIRST INFLATION TO 4 ATMOSPHERES (ATM), THE BALLOON RUPTURED. A SECOND 10X40MMX135CM ARMADA 35 BDC ALSO RUPTURED AT 4 ATM. A 10X40MMX80CM ARMADA 35 BDC RUPTURED AT 6 ATM, AND A 12X40MMX80CM ARMADA 35 BDC RUPTURED AT 4 ATM. ALTHOUGH NO DAMAGE WAS SEEN ON THE INDEFLATOR, IT WAS STATED THERE COULD BE AN ISSUE WITH THE INDEFLATOR, SINCE THE FOUR BALLOONS RUPTURED DURING INFLATION WITH THE SAME INDEFLATOR. A NEW INDEFLATOR AND AN UNSPECIFIED BDC WERE USED WITHOUT FURTHER ISSUES TO COMPLETE THE PROCEDURE. 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 7847374 ↗
• MalfunctionJun 27, 2018Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE SUBCLAVIAN ARTERY. THE 10X40MM ARMADA 35 BALLOON RUPTURED DURING THE THIRD INFLATION AT 10 ATMOSPHERES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7644098 ↗