Armada 1013469-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648208294), received between May 12, 2017 and May 12, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult To Position” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2017Difficult To Position; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE NON-TORTUOUS SUPERFICIAL FEMORAL ARTERY. AFTER POSITIONING A 5/6FR NON-ABBOTT SHEATH IN THE ANATOMY, A 5.5MM X 60MM X 150CM OTW ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED VIA RIGHT POSTERIOR TIBIAL ACCESS AND PRE-DILATATION WAS PERFORMED WITHOUT ISSUE. THE BDC WAS WITHDRAWN WITHOUT DIFFICULTY AND AN UNSPECIFIED STENT WAS DEPLOYED. WHEN ATTEMPTING TO RE-ADVANCE THE BDC THROUGH THE SAME SHEATH FOR POST-DILATATION OF THE STENT, RESISTANCE WAS FELT AGAINST THE SHEATH AND THE BDC WAS UNABLE TO BE ADVANCED THROUGH THE SHEATH. THE BDC WAS RETRACTED WITHOUT RESISTANCE. A NEW 5.5MM X 80MM X 150CM ARMADA 18 WAS ADVANCED THROUGH THE SAME SHEATH WITHOUT DIFFICULTY AND POST-DILATATION WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. THE 5.5MM X 60MM X 150CM OTW ARMADA 18 BDC WAS RECEIVED WITH A LONGITUDINAL BALLOON RUPTURE. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PHYSICIAN WAS NOT AWARE OF THE BALLOON RUPTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6564919 ↗