Armada B2070-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648155369), received between Apr 21, 2017 and May 30, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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.

• MalfunctionMay 30, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. A 5FRENCH (F) SHEATH AND .014 GUIDE WIRE WAS ADVANCED. THE 7.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AT NOMINAL PRESSURE AND WAS BEING REMOVED WHEN RESISTANCE WAS NOTED ON THE 5F SHEATH BUT WAS REMOVED INDEPENDENTLY. ANOTHER SAME SIZE ARMADA BDC WAS INFLATED ONCE AT NOMINAL; HOWEVER, THE SAME ISSUE OCCURRED DURING REMOVAL WITH THE 5F SHEATH BUT ALSO REMOVED INDEPENDENTLY. THE PHYSICIAN THOUGHT SWITCHING THE GUIDE WIRE TO .035 WOULD AID IN THE REMOVAL BUT HAD THE SAME RESISTANCE. A NON-ABBOTT BALLOON WAS USED WITH THE SAME SHEATH AND GUIDE WIRE FOR POST DILATATION AND COMPLETED 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 22115981 ↗
• MalfunctionMay 30, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. A 5FRENCH (F) SHEATH AND .014 GUIDE WIRE WAS ADVANCED. THE 7.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AT NOMINAL PRESSURE AND WAS BEING REMOVED WHEN RESISTANCE WAS NOTED ON THE 5F SHEATH BUT WAS REMOVED INDEPENDENTLY. ANOTHER SAME SIZE ARMADA BDC WAS INFLATED ONCE AT NOMINAL; HOWEVER, THE SAME ISSUE OCCURRED DURING REMOVAL WITH THE 5F SHEATH BUT ALSO REMOVED INDEPENDENTLY. THE PHYSICIAN THOUGHT SWITCHING THE GUIDE WIRE TO .035 WOULD AID IN THE REMOVAL BUT HAD THE SAME RESISTANCE. A NON-ABBOTT BALLOON WAS USED WITH THE SAME SHEATH AND GUIDE WIRE FOR POST DILATATION AND COMPLETED 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 22115935 ↗
• InjuryDec 13, 2024Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY RE-STENOSED LESION IN THE RIGHT COMMON ILIAC ARTERY. A 7X60MM ARMADA 35 WAS ADVANCED TO THE LESION AND INFLATED SEVERAL TIMES TO NOMINAL AND RATED BURST PRESSURE WITH NO ISSUE; HOWEVER, IT WAS NOTED THAT THE BALLOON WOULD ONLY PARTIALLY DEFLATE AFTER BEING HELD AT NEGATIVE FOR A COUPLE OF SECONDS. DURING SEVERAL ATTEMPTS TO REMOVE THE PARTIALLY INFLATED BALLOON WITH FORCE, RESISTANCE WAS FELT AND THE BALLOON WAS NOTED TO SEPARATE. THE PATIENT WAS TAKEN INTO SURGERY TO REMOVE THE SEPARATED BALLOON, AND THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA NOR REPORTED CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20930691 ↗
• MalfunctionJun 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT SUPERFICIAL ARTERY. REPORTEDLY, THE 7.0X60MM ARMADA BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE DEVICE WAS PREPPED PRIOR TO USE ACCORDING TO THE INSTRUCTIONS FOR USE. A LARGER 8.25 X 60 ARMADA WAS USED TO CONTINUE 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 17233697 ↗
• InjuryNov 11, 2021Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT POPLITEAL ARTERY WITH SEVERE CALCIFICATION. THE CALCIFIED POPLITEAL ARTERY STENOSIS WAS FIRST DILATED WITH A 5 MM CUTTING BALLOON AND THE 7X60 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED TO 10 ATMOSPHERES (ATM) AND THE BALLOON RUPTURED. THEN A 7FR SHEATH WAS PLACED IN THE RIGHT FEMORAL ARTERY AND AS THE RUPTURED BALLOON WAS ATTEMPTED TO BE WITHDRAWN, THERE WAS RESISTANCE. WHEN THE CATHETER WAS REMOVED, IT WAS NOTED THE BALLOON HAD BROKEN INSIDE THE PATIENT. ON X-RAY, ONE MARKER WAS ON THE RIGHT, AND THE OTHER ONE WAS ON THE LEFT. THE SHEATH WAS WITHDRAWN TO THE RIGHT AND THE FIRST MARKER WAS RETRIEVED USING A 10MM SNARE. IT WAS NOTED THAT THERE WAS NO BALLOON BUT ONLY MARKER. IT WAS ATTEMPTED TO REMOVE THE SECOND MARKER WITH THE BALLOON WITH THE SNARE BUT THIS WAS NOT SUCCESSFUL, SO IT WAS DECIDED TO TRAP THE MARKER WITH THE BALLOON TO THE EXTERNAL ILIAC ARTERY WITH A STENT. THE MARKER STOPPED MOVING, AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2021, THE PATIENT WAS UNDERGOING PRE-SCHEDULED BYPASS SURGERY, AND AFTER THE LEFT COMMON FEMORAL ARTERY WAS CLAMPED AND OPENED, THE BALLOON CATHETER W

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12796899 ↗
• MalfunctionNov 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 7.0MMX80MMX135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION. DURING THE FIRST INFLATION, TO 8 ATMOSPHERES, THE BALLOON RUPTURED. A 7.0MMX60MMX135CM ARMADA 35 BDC WAS ADVANCED TO THE TARGET LESION AND THE BALLOON RUPTURED AT 8 ATMOSPHERES, DURING THE FIRST INFLATION. ANOTHER ARMADA BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUES. 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 12732731 ↗
• MalfunctionAug 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED DE NOVO SUPERFICIAL FEMORAL ARTERY. ONCE AT THE LESION THE 7X60MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. ANOTHER SAME SIZE ARMADA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12386051 ↗
• MalfunctionDec 20, 2019Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING PREPARATION OF THE BALLOON CATHETER WHEN PULLING NEGATIVE AIR BUBBLES WERE SEEN. THEREFORE, THE BALLOON CATHETER WAS DECIDED NOT TO BE USED. THE BALLOON WAS PRESSURIZED BY THE TECHNICIAN AND IT WAS NOTED THE BALLOON HAD A PINHOLE. A NEW BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9506007 ↗
• MalfunctionApr 3, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED LEFT ILIAC CORONARY ARTERY. THE 7.0X60MMX135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION. THE BALLOON RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. THE BDC WAS REMOVED WITHOUT ISSUE AND ANOTHER SAME SIZE ARMADA 35 BDC WAS USED 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 7392655 ↗
• MalfunctionFeb 23, 2018Difficult to Insert; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 7X80MM ARMADA 35 BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION. THE BALLOON CATHETER WAS REMOVED AND AN UNKNOWN STENT WAS IMPLANTED; HOWEVER, WHEN ATTEMPTING TO RE-INSERT THE BALLOON CATHETER FOR POST-DILATATION IT COULD NOT BE INSERTED IN THE SHEATH. A 7X60MM ARMADA 35 BALLOON CATHETER WAS USED TO POST-DILATE THE STENT. THE BALLOON CATHETER WAS REMOVED AND AN ATTEMPT TO INSERT IT AGAIN FOR ADDITIONAL POST-DILATATION WAS MADE; HOWEVER, IT COULD NOT BE INSERTED INTO THE SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 7X80MM NON-ABBOTT BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURN DEVICE ANALYSIS NOTED PINHOLE RUPTURES IN BOTH OF THE ARMANDA BALLOONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7293144 ↗
• MalfunctionSep 27, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED PERIPHERAL ARTERY. A 7.0 X 60 MM ARMADA 35 BALLOON RUPTURED DURING USE. THE BALLOON WOULD NOT INFLATE BECAUSE THERE WAS A HOLE IN THE BALLOON. THE DEVICE WAS THEREFORE REMOVED FROM THE ANATOMY AND AN UNSPECIFIED ARMADA BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 6899607 ↗
• InjuryApr 21, 2017Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID BRACHIAL THAT WAS NON-TORTUOUS, NON-CALCIFIED AND 90% STENOSED. THE ARMADA 35 BALLOON DILATATION CATHETER WOULD NOT DEFLATE AFTER SEVERAL ATTEMPTS OVER A SPAN OF 30 MINUTES, EVEN USING THE INDEFLATOR. A SYRINGE WAS ALSO USED TO NO AVAIL. FINALLY, A GUIDE WIRE WAS USED TO PUNCTURE THE BALLOON SO THAT IT COULD BE REMOVED FROM THE ANATOMY. WHEN THE DEVICE WAS REMOVED FROM THE ANATOMY, THE BALLOON COULD STILL NOT BE DEFLATED. ANOTHER SAME SIZE ARMADA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE ARMADA WAS INFLATED TO 9 ATMOSPHERES. THERE WAS NO DIFFICULTY REPORTED DURING REMOVAL OF THE PROTECTIVE SHEATH AND THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. ALTHOUGH THERE WAS A DELAY IN THE PROCEDURE IT WAS NOT CLINICALLY SIGNIFICANT AND THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6513486 ↗