Armada 1013469-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648208331), received between Jun 8, 2017 and Jan 10, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 18, 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.

• InjuryJan 10, 2024Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.5X150MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE AND THE BALLOON WAS INFLATED TWICE TO NOMINAL PRESSURE; HOWEVER, DURING THE SECOND INFLATION THE BALLOON FAILED TO DEFLATE, ALTHOUGH NEGATIVE WAS HELD FOR 3 MINUTES. THE BALLOON WAS ONLY PARTIALLY ABLE TO BE DEFLATED; THEREFORE, THE BALLOON WAS CUT TO ALLOW CONTRAST TO BE REMOVED FROM THE BALLOON, SO THE BDC COULD BE REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18487481 ↗
• MalfunctionOct 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED POPLITEAL AND SUPERFICIAL FEMORAL ARTERY. THE 4.0X60MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT ATMOSPHERES (ATMS). A 5.5X150MM ARMADA 18 (BDC) RUPTURED DURING THE SECOND INFLATION AT 12ATMS. ANOTHER UNSPECIFIED ARMADA 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 15640980 ↗
• MalfunctionJan 3, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 5.50X150MM ARMADA 18 BALLOON DILATATION CATHETER, WHEN NEGATIVE WAS PULLED, A LEAK WAS NOTED IN THE BALLOON. THE DEVICE WAS NOT USED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9546307 ↗
• MalfunctionApr 24, 2018Material Rupture

  IT WAS REPORTED THAT THE ARMADA 18 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, THE DEVICE WOULD NOT INFLATE DUE TO A SUSPECTED PINHOLE RUPTURE. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. A SECOND SAME DEVICE WAS USED WITH THE SAME INFLATION DEVICE AND NO ISSUES NOTED. 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 7455245 ↗
• MalfunctionJun 8, 2017Leak/Splash

  IT WAS REPORTED THAT A 5.5 X 150 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS SELECTED FOR THE PROCEDURE. DURING PREPARATION (AIR ASPIRATION) PRIOR TO USE, AIR WAS OBSERVED COMING IN AT THE STRAIN RELIEF TUBING AT THE HUB OF THE PTA CATHETER. THERE WAS NO DAMAGE TO THE HUB NOTED. THE PTA CATHETER WAS NOT USED IN THE PROCEDURE. A NEW UNSPECIFIED PTA CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6623979 ↗