Armada A2040-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648156120), received between Apr 27, 2017 and Nov 18, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS UNKNOWN CAROTID ARTERY. THE 4.0X20MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS CHOSEN FOR PRE-DILATATION SINCE THE VESSEL SIZE OF THE LESION MATCHED THE SIZE OF THE ARMADA14 AND THERE WAS NO OTHER BALLOON ON SITE AT THAT TIME TO REPLACE IT. THE BDC WAS FLUSHED AND THE GUIDE WIRE LUMEN WAS CONNECTED TO THE UNSPECIFIED PRESSURE PUMP LUMEN; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. UNDER RADIOGRAPHY CONTRAST LEAKAGE WAS OBSERVED. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12835984 ↗
• MalfunctionApr 27, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT COMMON ILIAC ARTERY. WHEN THE OVER THE WIRE OMNI ELITE 9.0 MM/39 MM/80 CM STENT WAS OPENED, THE STENT WAS NOTED TO BE LOOSE ON THE BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER OMNI LINK STENT WAS USED AS REPLACEMENT. WHEN THE ARMADA 14 PTA BALLOON CATHETER WAS BEING USED FOR DILATATION THE BALLOON RUPTURED BELOW RATED BURST PRESSURE. THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE AND ANOTHER ARMADA 14 BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 6528605 ↗