Armada A2020-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648155963), received between Jun 18, 2018 and Feb 18, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED POSTERIOR TIBIAL (PT) LESION. THE 2.0X60MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE PROXIMAL PORTION OF THE PT LESION AND INFLATED HOWEVER THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT ISSUE. A 1.50X80MM ARMADA 14 BDC WAS THEN ADVANCED OVER A VIPER WIRE TO THE DISTAL PT. THE GUIDE WIRE WAS REMOVED TO PERFORM ANGIO, HOWEVER CONTRAST WAS UNABLE TO FLUSH THROUGH THE BDC AND THE GUIDE WIRE WAS UNABLE TO ADVANCE THROUGH THE GUIDE WIRE LUMEN OF THE BDC AGAIN. WIRE ACCESS WAS LOST AND THE ENTIRE SYSTEM HAD TO BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL ARMADA 14 CATHETERS. 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 24376460 ↗
• MalfunctionDec 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED POPLITEAL ARTERY WITH NO STENOSIS. THE 2.00X60MM ARMADA BALLOON WAS INFLATED ONCE AT 8 ATM AND RUPTURED. ANOTHER 2.00X60MM ARMADA 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20905444 ↗
• MalfunctionJun 15, 2023Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ANTERIOR TIBIAL ARTERY WITH ATHERECTOMY. THE LESION WAS CROSSED WITH A WHISPER GUIDE WIRE AND ANOTHER MANUFACTURE¿S GUIDE WIRE. ATHERECTOMY WAS PERFORMED WITH A TOTAL OF TWO PASSES. AFTER REMOVAL OF THE ATHERECTOMY DEVICE, THE 2.0X60 ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION. AFTER INFLATION, THE GUIDE WIRE WAS ATTEMPTED TO BE EXCHANGED, BUT MET RESISTANCE WITH THE BDC. THE TIP OF THE GUIDE WIRE SEPARATED; HOWEVER, REMAINED ATTACHED TO THE TIP OF THE BDC. ONCE THE BDC WAS REMOVED FROM THE ANATOMY, THE TIP OF THE BDC WAS NOTED TO BE CURLED WITH THE SEPARATED TIP OF THE GUIDE WIRE INSIDE OF IT. A NEW ARMADA 14 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 17138434 ↗
• MalfunctionJun 26, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS TIBIAL ARTERY. AFTER CROSSING THE LESION WITH A COMMAND ES GUIDE WIRE THE 2.0X60MM ARMADA 14 DILATATION CATHETER WAS NOTED TO NOT FULLY INFLATE WHEN INFLATED TO NOMINAL PRESSURE AS THE HUB WAS NOTED TO BE LEAKING. ANOTHER 2.0X40MM ARMADA 14 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 14824251 ↗
• MalfunctionJul 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 100% STENOSED, TOTAL OCCLUSION OF THE RIGHT ANTERIOR TIBIAL ARTERY. A 2X60MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL BALLOON DILATATION CATHETER (BDC) WAS PREPARED FOR USE AND ADVANCED TO THE LESION WITHOUT ISSUE. THE ARMADA BALLOON WAS INFLATED 1 TIME TO 8 ATMOSPHERES (ATM), WHEN THE BALLOON RUPTURED. THE RUPTURED BALLOON WAS ABLE TO BE SIMPLY REMOVED, AND ANOTHER SAME SIZE ARMADA WAS 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 12193866 ↗
• MalfunctionOct 8, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.0X60MM ARMADA 14 BALLOON DILATATION CATHETER (BDC), THE DEVICE WAS BEING FLUSHED WHEN A LEAK WAS NOTED IN THE BALLOON. THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER ARMADA 14 WAS USED TO SUCCESSFULLY COMPETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10649840 ↗
• MalfunctionJun 18, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. AN ATTEMPT WAS MADE TO INFLATE THE 2.0 X 60 MM ARMADA DILATATION CATHETER BALLOON. HOWEVER, IT WAS NOTED THAT THE DEVICE WOULD NOT HOLD PRESSURE AND A HOLE IN THE BALLOON WAS SUSPECTED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND A SECOND ARMADA WAS USED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7610073 ↗