Armada B2120-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648155550), received between Mar 23, 2018 and Feb 6, 2025 — classified as 2 injuries, 7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE 8X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED ONCE TO 15 ATMOSPHERES (ATM) AND RUPTURED. A SECOND 8X40 MM ARMADA 35 PTA CATHETER WAS INFLATED ONCE TO 15 ATM AND RUPTURED. A 12X40 MM ARMADA 35 PTA CATHETER RUPTURED DURING THE FIRST INFLATION TO 10 ATM. ANOTHER 12 MM ARMADA 35 PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 21326848 ↗
• MalfunctionJun 10, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE THORACIC AORTA. THE 12X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED HOWEVER IT WAS NOTED THE GUIDE WIRE DID NOT EXIT THE BDC. DIFFERENT GUIDE WIRES WERE ATTEMPTED HOWEVER THE SAME ISSUE OCCURRED THEREFORE THE BDC WAS REMOVED FROM THE ANATOMY. ANOTHER ARMADA 35 OF THE SAME SIZE AND LOT WAS OPENED HOWEVER THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING ANOTHER ARMADA 35. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS OF BOTH ARMADA DEVICES CONFIRMED FOREIGN MATERIAL INSIDE THE HIB GUIDE WIRE PORT AT THE PROXIMAL GLUE PORT AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498065 ↗
• MalfunctionJun 10, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE THORACIC AORTA. THE 12X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED HOWEVER IT WAS NOTED THE GUIDE WIRE DID NOT EXIT THE BDC. DIFFERENT GUIDE WIRES WERE ATTEMPTED HOWEVER THE SAME ISSUE OCCURRED THEREFORE THE BDC WAS REMOVED FROM THE ANATOMY. ANOTHER ARMADA 35 OF THE SAME SIZE AND LOT WAS OPENED HOWEVER THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING ANOTHER ARMADA 35. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS OF BOTH ARMADA DEVICES CONFIRMED FOREIGN MATERIAL INSIDE THE HIB GUIDE WIRE PORT AT THE PROXIMAL GLUE PORT AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498054 ↗
• MalfunctionAug 1, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 12X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), THE BDC DID NOT INFLATE, AND AIR ASPIRATED FROM THE BALLOON. A BALLOON RUPTURE WAS SUSPECTED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436121 ↗
• MalfunctionJul 9, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT DURING DEVICE PREPARATION AND BEFORE USE, THE PROTECTIVE SHEATH OF THE ARMADA 35 COULD NOT BE REMOVED AND THE PROXIMAL SHAFT BROKE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12145415 ↗
• InjuryMay 27, 2021Entrapment of Device; Off-Label Use; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Off-Label Use; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PULMONARY VEIN. A 12X40MM ARMADA 35 BALLOON WAS ADVANCED TO THE LESION WITHOUT ISSUE. THE BALLOON WAS INFLATED 3 TIMES TO 14 ATMOSPHERES FOR 10 SECONDS, THERE WAS NO DIFFICULTY MAINTAINING PRESSURE, HOWEVER THE BALLOON RUPTURED ON THE 3RD INFLATION. WHEN SIMPLY WITHDRAWING THE DEVICE FROM THE ANATOMY, RESISTANCE WAS MET WITH THE GUIDE WIRE AND THE SHAFT OF THE ARMADA BROKE AND DID NOT COME OUT COMPLETELY. THE DEVICE WAS REMOVED ACCESSING THE OPPOSITE VEIN WITH A SNARE KIT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893964 ↗
• MalfunctionMar 27, 2021Material Rupture; Material Rupture

  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. SUBSEQUENT TO THE INITIALLY FILED MDR, DEVICE ANALYSIS NOTED THAT THE INNER MEMBER FOR THE 12X40MM ARMADA 35 WAS SEPARATED AND THE PROXIMAL BALLOON MARKER APPEARED TO BE DISLODGED. THE ACCOUNT COULD NOT CONFIRM DEVICE ANALYSIS FINDINGS BUT CONFIRMED THAT NO PART OF THE DEVICE REMAINED IN THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11578981 ↗
• InjuryOct 31, 2019Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TIGHT ATRIOVENTRICULAR (AV) FISTULA. THE 12X40MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE AND INFLATED 6 TIMES TO 14 ATMOSPHERES AND RUPTURED. WHEN THE BALLOON RUPTURED, IT BECAME ENTANGLED WITH AN UNSPECIFIED GUIDE WIRE. THE GUIDE WIRE AND THE BALLOON WERE RETRACTED TO THE SHEATH AND COULD NOT BE WITHDRAWN FROM THE SHEATH SO ALL WAS REMOVED TOGETHER EXCEPT FOR 8 INCHES OF GUIDE WIRE. THE GUIDE WIRE WAS THEN CUT IN ORDER TO REMOVE THE BALLOON. THERE WAS SIGNIFICANT ACCESS SITE PAIN.

  Patient problems: Pain

  MAUDE report 9261755 ↗
• MalfunctionMar 23, 2018Material Rupture; Torn Material

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY TORTUOUS, HEAVILY CALCIFIED, ECCENTRIC, DE NOVO, MID COMMON ILIAC, THE ARMADA 35 BALLOON WAS INFLATED AT 10 ATMOSPHERES (ATM), BUT RUPTURED. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7367529 ↗