Armada F2012-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648182839), received between Jun 14, 2019 and Jun 19, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 100% TOTAL OCCLUSION. THE 1.2X20 MM ARMADA XT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER BECAME STUCK WITH A NON-ABBOTT GUIDE WIRE AND BOTH DEVICES HAD TO BE REMOVED FROM THE ANATOMY TOGETHER AS A UNIT. THE VESSEL ACCESS WAS LOST AND A NEW WIRE AND BALLOON WERE USED TO COMPLETE THE PROCEDURE; HOWEVER, THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567749 ↗
• MalfunctionMar 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION. THE 1.2X20MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991949 ↗
• MalfunctionJul 5, 2023Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Material Twisted/Bent; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 80% STENOSED LESION IN THE DORSALIS PEDIS. A 1.2X20MMX145CM ARMADA 14 OVER THE WIRE (OTW) BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER AN HT COMMAND 14 GUIDE WIRE (GW) AND ATTEMPTING TO NAVIGATE AROUND THE PEDAL ARCH, WHEN THE SHAFT OF THE BDC BECAME DEFORMED AND ADVANCING BECAME DIFFICULT. IT WAS DECIDED TO REMOVE THE GUIDE WIRE AND INJECT CONTRAST, HOWEVER THE WIRE COULD NOT BE REMOVED FROM THE BDC. THE GUIDE WIRE AND BDC WERE REMOVED AS A SINGLE UNIT, AND IT WAS NOTED THAT THE BALLOON VISIBLY BECAME BUNCHED UP ON THE WIRE CAUSING IT TO BECOME STUCK. A SECONDARY BALLOON AND GUIDE WIRE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259665 ↗
• MalfunctionApr 13, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE DEVICE WAS RECEIVED, AND THE BALLOON WAS TIGHTLY FOLDED INDICATING THAT THE BALLOON HAD NOT BEEN INFLATED. THE ACCOUNT STATED THAT THE BALLOON WAS NEVER INFLATED AS IT WAS USED TO CROSS A TIGHT LESION. AN UNSPECIFIED WIRE WAS SWAPPED AND THE BALLOON CAME OUT; AND, THE BALLOON WAS RE-INSERTED AND ATTEMPTED TO BE ADVANCED THROUGH THE TIGHT LESION. THE BALLOON FELT WEAK AND STRETCHED IN A SEGMENT AND WAS DECIDED NOT TO BE USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16733872 ↗
• MalfunctionOct 7, 2019Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MILDLY TORTUOUS ANTERIOR TIBIAL ARTERY (ATA). THE 1.2X20 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITH DIFFICULTY TO THE LESION. REPORTEDLY, THERE WERE NO ISSUES DURING PREPARATION OF THE DEVICE. THE CATHETER WAS INFLATED ONCE TO 8 ATMOSPHERES (ATM) AND RUPTURED. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9164126 ↗
• MalfunctionJun 14, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE ARMADA 14 XT BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE, INFLATED TWICE TO 10 ATMOSPHERES AND RUPTURED. A NON-ABBOTT BDC 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 Consequences Or Impact To Patient

  MAUDE report 8701821 ↗