Armada 1013465-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648207907), received between Feb 11, 2022 and Sep 19, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT ANTERIOR TIBIAL ARTERY. THE 3.0X120MM ARMADA 18 BALLOON WAS ATTEMPTED TO BE ADVANCED; HOWEVER, THE DEVICE KINKED. THE KINKED CATHETER COULD NOT ADVANCE OVER THE WIRE AND WAS ATTEMPTED TO BE REMOVED INDEPENDENTLY; HOWEVER, IT WAS UNSUCCESSFUL. THE ARMADA 18 WAS REMOVED AS A SINGLE UNIT WITH THE WIRE. A NEW WIRE AND BALLOON WERE 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 20258299 ↗
• MalfunctionSep 18, 2024Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION. THE 3X120 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS BEING ADVANCED OVER THE GUIDE WIRE AND THE CATHETER KINKED DURING ADVANCEMENT WITHOUT RESISTANCE. THE DEVICES WERE REMOVED TOGETHER AS THE BALLOON COULD NOT BE REMOVED FROM THE GUIDE WIRE. A NEW BALLOON AND NEW GUIDE WIRE WERE 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 20248699 ↗
• MalfunctionJun 2, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. THE 3.0X120MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) MET RESISTANCE DURING ADVANCEMENT WITH A 6FR SHEATH. ONCE AT THE LESION THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT WAS NOTED TO BE LOSING PRESSURE AND WOULD NOT INFLATE. A NEW 2.5 ARMADA 18 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052819 ↗
• MalfunctionMar 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED, THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY. A 3.0X120MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITHOUT ISSUE, AND ADVANCED TO THE LESION WITHOUT RESISTANCE. HOWEVER, UPON THE FIRST ATTEMPTED INFLATION, THE BALLOON RUPTURED, AND WOULD NOT HOLD ANY PRESSURE. THE BDC WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. A NEW 3.0X120MM ARMADA 18 BDC WAS USED, WITHOUT ISSUE TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587659 ↗
• MalfunctionFeb 11, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, WHEN ASPIRATING THE 3.0 X 120 MM ARMADA 18 DILATATION CATHETER, AIR WAS NOTED IN THE SYSTEM. IT WAS SUSPECTED THAT THERE WAS A HOLE IN THE SYSTEM. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A SECOND DEVICE WAS THEN USED IN THE PROCEDURE WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518563 ↗