Armada 1013469-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648208287), received between Jan 11, 2018 and Nov 15, 2024 — classified as 3 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 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 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDUREIT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE POPLITEAL ARTERY WITH MILD CALCIFICATION. THE 5.5X40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. HOWEVER, WHEN THE BALLOON WAS INFLATED TO 4 ATMOSPHERES (ATM), THE BALLOON WAS LOSING PRESSURE [MATERIAL RUPTURE]. THE BALLOON WAS THEN INFLATED TO 8 ATM AND THE BALLOON STILL WOULD NOT MAINTAIN PRESSURE. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT, ENDING THE PROCEDURE AS THE PATIENT DID NOT NEED FURTHER TREATMENT. IT WAS NOTED THAT AN ATTEMPT WAS MADE TO INFLATE THE BALLOON OUTSIDE THE PATIENT, AND A LEAK WAS NOT OBSERVED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. WAS TO TREAT A LESION IN THE POPLITEAL ARTERY WITH MILD CALCIFICATION. THE 5.5X40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCE TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO 4 ATMOSPHERES (ATM) AND THE BALLOON WAS LOSING PRESSURE. THE BALLOON WAS THEN INFLATED TO 8 ATM AND THE BALLOON STILL WOULD NOT MAINTAIN PRESSURE. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694372 ↗
• MalfunctionJul 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS DISTAL LEFT SUPERFICIAL FEMORAL ARTERY. THE 5.5X40MM ARMADA 18 BALLOON RUPTURED AT 8ATM ON THE FIRST INFLATION. A NEW 6X40MM ARMADA BALLOON WAS 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 10254395 ↗
• MalfunctionJan 11, 2018Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH NO TORTUOSITY OR CALCIFICATION. THE 5.5 X 40 MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE. THE BDC BEGAN TO BE INFLATED IN AN ATTEMPT TO GO TO NOMINAL PRESSURE, BUT A LEAK WAS OBSERVED AT THE HUB. THE INFLATION WAS STOPPED, AND THE DEVICE WAS REMOVED WITHOUT ISSUE, AND REPLACED. A NEW 5.5 X 40 MM ARMADA 18 BDC 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 Consequences Or Impact To Patient

  MAUDE report 7184763 ↗