Armada A2020-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648155956), received between Mar 28, 2017 and Jan 27, 2026 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION. THE 2X40 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. ANOTHER SAME SIZE 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 24193273 ↗
• MalfunctionSep 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.0X40 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, WHEN PULLING NEGATIVE, AIR CAME IN, INDICATING A LEAK. THEREFORE, THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER ARMADA 14 PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22957814 ↗
• MalfunctionApr 28, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT DORSALIS PEDIS ARTERY. A 2X40MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER A 2X40MM NON-ABBOTT GUIDEWIRE (GW) AND INFLATED THREE TIMES TO 6ATM; HOWEVER, THE GW WAS NOTED TO BREAK. THE BDC WAS FULLY DEFLATED, AND DURING AN ATTEMPT TO WITHDRAW THE BROKEN GW IT WAS NOTED THAT THE WIRE COULD NOT BE REMOVED THROUGH THE BDC. THEREFORE, THE DEVICE WAS REMOVED AS A SINGLE UNIT AND THE PROCEDURE WAS CONCLUDED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918177 ↗
• MalfunctionFeb 4, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THE TIBIOPERONEAL (TP) TRUNK ARTERY WERE TREATED DURING THIS CASE. THE SPARTACORE GUIDEWIRE FAILED TO CROSS THE SFA AND PERFORATED THE SFA ON CLOSURE PASSAGE. THE BLEEDING/PERFORATION WAS ALSO RELATED TO ONE OF THE DILATATION CATHETERS. THERE WAS NO DEVICE DEFICIENCY RELATED TO THE PERFORATION. THE PERFORATION WAS TREATED WITH A COVERED STENT AND IT RESOLVED THE SAME DAY. THE 2.0X40 MM ARMADA 14 BALLOON DILATATION CATHETER WAS PREPARED CORRECTLY AND MET RESISTANCE WITH CALCIFIED ANATOMY DURING ADVANCEMENT TO THE TP. THE ARMADA RUPTURED WITH THE FIRST INFLATION AT 14 ATMOSPHERES OF PRESSURE DUE TO THE CALCIUM. THERE WAS NO ADVERSE PATIENT SEQUELAE OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305127 ↗
• MalfunctionMar 27, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS ANTERIOR TIBIAL ARTERY THAT IS 80% STENOSED. AFTER CROSSING THE LESION WITH A COMMAND ES GUIDE WIRE A 2.0X40MM ARMADA 14 BALLOON DILATATION WAS BEING PREPARED; HOWEVER, A LEAK WAS NOTED AT THE HUB OUTSIDE THE PATIENT'S ANATOMY. A NEW 2.0X60MM ARMADA WAS USED TO SUCCESSFULLY COMPLETE ANGIOPLASTY. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619704 ↗
• MalfunctionMay 12, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A VERY SMALL LESION IN THE DISTAL ANTERIOR TIBIAL ARTERY WITH NO TORTUOSITY OR CALCIFICATION REPORTED. THE ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE TO THE LESION BUT UPON INFLATION, THE DEVICE WOULD NOT HOLD PRESSURE AND WOULD NOT INFLATE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE. A NEW ARMADA 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 14372945 ↗
• MalfunctionAug 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE ANTERIOR TIBIAL VEIN. A 2.0X40MM AND 2.0X80MM ARMADA BALLOON DILATATION CATHETERS (BDC) RUPTURED. ONE BALLOON WAS INFLATED ONCE, THE OTHER BALLOON WAS INFLATED TWICE. BOTH WERE INFLATED TO NOMINAL PRESSURE AND BOTH RUPTURED AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED AFTER USE OF THE DEVICES WITH SATISFACTORY RESULTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8908441 ↗
• MalfunctionMay 29, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO, CONCENTRIC LESION IN A MILDLY TORTUOUS, 99% STENOSED POSTERIOR TIBIAL ARTERY. A 2.0X40MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE AND THE BALLOON DID NOT EXPAND AND WAS LOSING PRESSURE DURING THE FIRST INFLATION. A NON-ABBOTT BALLOON 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 Consequences Or Impact To Patient

  MAUDE report 8651904 ↗
• MalfunctionSep 22, 2017Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LOWER EXTREMITY. DURING INFLATION OF THE 2.0 X 40 MM ARMADA BALLOON CATHETER BALLOON AT THE LESION THE PRESSURE WAS UNSTABLE. AS THE CORRECT PRESSURE COULD NOT BE REACHED THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT. AFTER RETRACTION OF THE SHAFT OF THE DEVICE WAS OBSERVED TO BE LEAKING CLOSE TO THE GUIDE WIRE EXIT NOTCH. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THE BALLOON CATHETER TO THE LESION. ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6888000 ↗
• MalfunctionMar 28, 2017Inflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A TARGET LESION IN THE PERONEAL ARTERY, THE PHYSICIAN ADVANCED THE 2.0 X 40 MM ARMADA DILATATION CATHETER INTO THE PATIENT ANATOMY. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, THE BALLOON DID NOT FULLY INFLATE. THE DEVICE WAS REMOVED AND A SECOND BALLOON WAS USED. 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 6440671 ↗