Armada F2020-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648182938), received between Aug 15, 2019 and Dec 16, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 18, 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 16, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Twisted/Bent; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Twisted/Bent

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS PROVIDED: THE 2.0X20 ARMADA 14 XT BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER THE HT COMMAND 14 ES GUIDE WIRE THROUGH A 5F CATHETER. UPON REMOVAL OF THE GUIDEWIRE, RESISTANCE WAS NOTED DUE TO THE BDC. DURING RE-ADVANCEMENT OF THE GUIDEWIRE, RESISTANCE WAS NOTED DUE TO THE ARMADA AND THE GUIDE WIRE GOT STUCK DISTALLY. THE ARMADA 14 BDC WAS REMOVED, AND THE SHAFT WAS TWISTED. THE ARMADA 14 BDC WAS STRAIGHTENED AND ABLE TO CROSS THE LESION; HOWEVER, THE SAME ISSUE OCCURRED, AND THE HT COMMAND GUIDE WIRE SEEMED TO PREMATURELY EXIT THE CATHETER. THE BDC AND GUIDEWIRE WERE REMOVED. A NEW ARMADA 14 XT OVER THE SAME HT COMMAND 14 ES GUIDEWIRE, 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 23819348 ↗
• MalfunctionJun 30, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT AN OCCLUDED, HEAVILY CALCIFIED, MILDLY TORTUOUS POPLITEAL ARTERY USING A 4GX25CM HI-TORQUE (HT) COMMAND 14 GUIDE WIRE AND A 2.0X20MM ARMADA 14 XT BALLOON DILATATION CATHETER (BDC). THE HT COMMAND GUIDE WIRE AND ARMADA 14 BDC STUCK TOGETHER DURING REMOVAL AND WERE WITHDRAWN AS ONE UNIT. A 4.0X120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BDC WAS TO BE USED IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS LEFT INTERIOR TIBIAL. DURING ADVANCEMENT OF THE ARMADA 14 PTA BDC, RESISTANCE WAS MET DUE TO ANATOMY. ONCE AT THE LESION, THE ARMADA 14 PTA BDC WAS INFLATED ONCE TO 6 ATMOSPHERES AND COLLAPSED ON ITSELF LIKE AN ACCORDION. THE PROCEDURE WAS TERMINATED AND IT IS UNKNOWN IF OTHER DEVICES WERE 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 22363385 ↗
• MalfunctionDec 11, 2024Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS DORSALIS PEDIS ARTERY. A HI-TORQUE COMMAND GUIDEWIRE WAS REMOVED FROM THE PATIENT AND BACKLOADED INTO THE 2.0X20MM ARMADA 14 BALLOON DILATATION CATHETER (BDC); HOWEVER, THE GUIDEWIRE BECAME STUCK. THE GUIDE WIRE COULD NOT ADVANCE FORWARD NOR BACKWARDS AND BOTH DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT THROUGH THE SHEATH. A BOW ON THE DISTAL TIP AND SHAFT OF THE ARMADA BDC WAS OBSERVED. THE PROCEDURE WAS ABORTED. THERE WAS 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 20905713 ↗
• MalfunctionMay 7, 2024Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT IN A PROCEDURE TO TREAT A BELOW THE KNEE (BTK) OCCLUSION. AFTER THE 2X20MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS INFLATED 4-5 TIMES AT AN UNKNOWN PRESSURE, THE BALLOON DID NOT COMPLETELY DEFLATE. THE BDC WAS REMOVED FROM THE PATIENT. 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 19264171 ↗
• MalfunctionMay 22, 2023Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Difficult to Remove; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE POSTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 2.00X20MM ARMADA BALLOON DILATATION CATHETER ( BDC) WAS USED IN A PROCEDURE; HOWEVER, A GUIDEWIRE (GW) AND THE BDC BECAME STUCK TOGETHER AND WERE NOT ABLE TO BE REMOVED INDEPENDENTLY. THE BDC AND GW WERE REMOVED FROM THE PATIENT AS A SINGLE UNIT. AFTER REMOVAL, OUTSIDE THE PATIENT ANATOMY THE BALLOON PROXIMAL SHAFT WAS NOTED TO BE CRUMPLED [BUNCHED] AND WHEN ATTEMPTING TO SEPARATE THE BALLOON FROM THE GW THE BALLOON BROKE [SEPARATED] INTO SEVERAL PIECES. 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 16976202 ↗
• MalfunctionFeb 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A VESSEL BEHIND THE KNEE WITH MODERATE CALCIFICATION, NO TORTUOSITY AND 90% STENOSIS. THE 2.0X20 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED TO 12 ATMOSPHERES (ATM) AND RUPTURED. ANOTHER ARMADA 14 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 16453691 ↗
• MalfunctionFeb 22, 2023Stretched; Failure to Advance; Difficult to Advance; Stretched; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON THE BACK TABLE, DURING PREP, A COMMAND GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED THROUGH THE 2X20 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER BUT THERE WAS RESISTANCE. THERE MAY HAVE BEEN A BLOCKAGE IN THE LUMEN OF THE BALLOON OR THE LUMEN WAS BENT. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE WITH THE SAME COMMAND GUIDE WIRE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT A POTENTIALLY ABBOTT GUIDE WIRE WAS RETURNED FROZEN IN THE LUMEN OF THE ARMADA PTA CATHETER. THE PROXIMAL END OF THE BALLOON WAS WRINKLED AND THE INNER MEMBER WAS STRETCHED THEN BUNCHED AT SAME LOCATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420303 ↗
• MalfunctionOct 24, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A 2.0X20MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE INFLATED WHEN A LEAK WAS NOTICED FROM THE GUIDE WIRE (GW) PORT. THE BDC WAS REMOVED, AND ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 15664150 ↗
• MalfunctionOct 3, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS A RE-CANALIZATION TO TREAT A LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY. THE 2.0X20MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) SHOWED A PERFORATION IN THE BODY OF THE CATHETER WHERE THE THREAD COMES OUT AND PARALLEL TO THE RADIOPAQUE MARKS OF THE BALLOON. FLUOROSCOPIC IMAGE SHOWED THE GUIDE WIRE WAS OUTSIDE THE BALLOON AND PARALLEL TO THE RADIOPAQUE MARKS. 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 15530914 ↗
• MalfunctionJul 29, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. DURING ADVANCEMENT OF AN UNSPECIFIED COMMAND ES GUIDE WIRE THRU THE LUMEN OF A 2X20MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER PEELING WAS NOTICED ON THE GUIDE WIRE, WHICH THEN BECAME STUCK, SO THE DEVICES WERE REMOVED TOGETHER. AN UNSPECIFIED ARMADA XT BALLOON AND COMMAND ES GUIDE WIRE WERE 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 12245886 ↗
• MalfunctionAug 15, 2019Inflation Problem; Product Quality Problem; Stretched; Inflation Problem; Product Quality Problem; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RADIAL CEPHALIC ARTERY. THE ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED TWICE TO 14 ATMOSPHERES (ATM) AND WOULD ONLY PARTIALLY INFLATE. THE DEVICE WAS HOLDING PRESSURE AND THE BALLOON WOULD NOT FULLY INFLATE. ADDITIONALLY, THE PROXIMAL END OF THE BALLOON APPEARED ELONGATED. ANOTHER ARMADA 14 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. RETURNED DEVICE ANALYSIS IDENTIFIED A STRETCHED SHAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8898857 ↗