Armada 1013466-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648207983), received between Sep 7, 2018 and Nov 11, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2019Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE 4.0X100 ARMADA 18 BALLOON DILATATION CATHETER WAS INSERTED TO POST DILATE THE 6.0X100 ABSOLUTE PRO VASCULAR STENT IN THE SUPERFICIAL FEMORAL ARTERY. WHEN THE ARMADA WAS INFLATED TO NOMINAL PRESSURE, IT APPEARED TO BE THE CORRECT 100 MM LENGTH; HOWEVER, THE BALLOON MARKERS DID NOT LINE UP WITH THE SHOULDERS OF THE BALLOON. THE MARKERS APPEARED SHORTER THAN THE 100 MM LENGTH. THE STENT WAS SUCCESSFULLY POSTDILATED AND THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9305536 ↗
• MalfunctionNov 11, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED PROXIMAL SUPERFICIAL FEMORAL ARTERY THAT WAS 90% STENOSED. DURING POST-DILATATION, A 4X100MM ARMADA BALLOON DILATATION CATHETER WAS INFLATED 4-5 TIMES AT UNSPECIFIED ATMOSPHERES WHEN IT WAS NOTED THAT THE BALLOON DID NOT INFLATE THE ENTIRE LENGTH OF THE PREVIOUSLY IMPLANTED STENT AS EXPECTED, BUT CONTINUED TO USE IT TO COMPLETE STENT APPOSITION. THE BALLOON IS REPORTED TO BE MISS-SIZED IN ACCORDANCE WITH THE LABELED SIZE. THERE WERE NO ISSUES WITH THE ACTUAL BALLOON INFLATION. ONCE REMOVED OUT OF THE ANATOMY, IT WAS NOTED THAT THE BALLOON WAS SHORTER THAN IT SHOULD BE. 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 9304558 ↗
• MalfunctionSep 7, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE POPLITEAL ARTERY THAT WAS HEAVILY CALCIFIED. THE ARMADA 18 4 X 100 MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON WAS INFLATED TWICE FOR TREATMENT. DURING REMOVAL, THERE WAS RESISTANCE WITH THE NON-ABBOTT GUIDE WIRE AND BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7857825 ↗