Armada A2025-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648156007), received between Jun 15, 2017 and Dec 31, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2020Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVY CALCIFIED, MILDLY TORTUOUS, 50% STENOSED ANTERIOR TIBIAL ARTERY. A 2.5X20MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS UNPACKED, AND IT WAS NOTED THAT THE SHAFT WAS BENT. THE PTA FACED RESISTANCE DURING ADVANCEMENT AND WITHDRAWAL OVER A COMMAND ES GUIDE WIRE, AND SOME FORCE WAS APPLIED. A 3X40MM ARMADA 14 PTA AND WHISPER ES GUIDE WIRE WERE 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 11102331 ↗
• MalfunctionJun 15, 2017Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL ANTERIOR TIBIAL ARTERY. THERE WERE NO ISSUES NOTED DURING PREPARATION OF THE 2.5 MM X 20 MM ARMADA 14 BALLOON CATHETER AND NO RESISTANCE FELT DURING ADVANCEMENT OF THE BALLOON CATHETER TO THE LESION. DURING ATTEMPTED INFLATION OF THE BALLOON IT WOULD NOT HOLD PRESSURE AND CONTRAST COULD BE SEEN COMING BACK INTO THE INFLATION DEVICE. A LEAK WAS SUSPECTED AT THE HUB OF THE DEVICE. A NEW ARMADA 14 BALLOON CATHETER WAS USED SUCCESSFULLY FOR 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 6645150 ↗