Armada A2015-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648155925), received between Jun 27, 2017 and Oct 21, 2025 — classified as 1 injury, 6 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED TIBIAL ARTERY. THE 1.5X80MM ARMADA 14 BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. ANOTHER ARMADA 14 BALLOON 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 23353488 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED TO 6-8 ATMOSPHERES AND THE TIP WAS NOTED TO BREAK. NO PARTS WERE MISSING FROM THE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927945 ↗
• MalfunctionAug 31, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, DE NOVO LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. A 1.5X80MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION TO 24 ATMOSPHERES (ATM). IT IS SUSPECTED THAT THE RUPTURE WAS DUE TO THE CALCIFIED LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER ARMADA BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331765 ↗
• MalfunctionDec 3, 2020Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS WHICH INDICATED THAT THE SIDE ARM SEPARATED DURING DEVICE PREPARATION AND THE DEVICE WAS PRESSURIZED OUTSIDE THE PATIENT ANATOMY. THE DEVICE WAS USED IN THE ANATOMY AS A SUPPORT CATHETER; HOWEVER, NO ATTEMPT WAS MADE TO PRESSURIZE THE BALLOON INSIDE THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10939387 ↗
• InjuryOct 8, 2020Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONICALLY TOTAL OCCLUDED (CTO), HEAVILY CALCIFIED, AND MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. A 1.5X80MM ARMADA 14 PTA BALLOON CATHETER (BDC) WAS PREPPED OUTSIDE THE ANATOMY ACCORDING TO THE INSTRUCTIONS FOR USE WITHOUT ANY ISSUES. ON ADVANCING THE BDC, RESISTANCE WITH THE ANATOMY WAS FELT AND FORCE WAS APPLIED. THE BALLOON WAS INFLATED ONCE TO 20 ATMOSPHERES. DURING REMOVAL OF THE BDC, RESISTANCE WITH THE CALCIFICATION WAS FELT AND ONLY THE SHAFT OF THE BDC CAME OUT. A HORIZONTAL SEPARATION AT THE LEVEL OF THE BALLOON HAD OCCURRED AND WAS CONFIRMED VIA ANGIOGRAPHY. BOTH PARTS OF THE BALLOON WITH MARKERS REMAINED INSIDE THE VESSEL CAUGHT ON THE CALCIFICATION. UNSPECIFIED ARMADA 14 BDCS WERE USED FOR DILATATION PRIOR TO SNARING OUT THE PROXIMAL PIECE OF THE BALLOON. SEVERAL ADDITIONAL ATTEMPTS WERE MADE TO REMOVE THE DISTAL PIECE; HOWEVER, THIS WAS UNSUCCESSFUL. A 3X100MM XPERT PRO STENT WAS IMPLANTED TO EMBED THE REMAINING SEPARATED PORTION OF THE BALLOON TO THE VESSEL WALL. A DELAY OF 45-50 MINUTES WAS REPORTED. THE FINAL RESULT WAS BETTER BLOOD FLOW TO THE FOOT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10651497 ↗
• MalfunctionOct 10, 2018Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT SOME RESISTANCE WAS MET WITH THE CALCIFIED ANATOMY DURING ADVANCEMENT OF THE 1.5X80 MM ARMADA 14 TO THE HEAVILY CALCIFIED LEFT POPLITEAL ARTERY. DURING THE FIRST INFLATION, THE ARMADA 14 RUPTURED BEFORE IT HAD REACHED NOMINAL PRESSURE. THE BALLOON RUPTURE WAS THOUGHT TO BE RELATED TO THE HEAVY CALCIUM. THE ARMADA 14 WAS REMOVED IN ONE PIECE WITHOUT INCIDENT. A 3.0 MM ARMADA 14 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952930 ↗
• MalfunctionJun 27, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A FEMORAL ARTERY. A 1.5 X 80 MM ARMADA 14 BALLOON WAS BEING INFLATED WHEN IT RUPTURED AT 14 ATMOSPHERES AFTER BEING INFLATED 2 TO 3 TIMES. THEN A 3.0 X 60 MM ARMADA 14 BALLOON WAS BEING INFLATED WHEN IT ALSO RUPTURED AT 14 ATMOSPHERES AFTER BEING INFLATED 2 TO 3 TIMES. ANOTHER UNSPECIFIED BALLOON CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6670045 ↗