Armada B2090-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648155499), received between Aug 20, 2022 and Aug 20, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2022Device Damaged by Another Device; Difficult to Advance; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 98% STENOSED LESION IN THE LEFT EXTERNAL ILIAC ARTERY. A 9X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS IMPLANTED WITHOUT ISSUE. DURING POST-DILATATION, WHILE ADVANCING WITH A 9X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), THE PHYSICIAN PUSHED THE EDGE OF THE TIP OF THE ARMADA BDC AGAINST THE IMPLANTED ABSOLUTE PRO STENT CAUSING RESISTANCE BETWEEN THE DEVICES, AND THE ABSOLUTE PRO SESS BECAME STRETCHED. THE BDC WAS REMOVED AND REPLACED WITH A VIATRAC 14 PLUS PERIPHERAL BALLOON DILATATION CATHETER TO COMPLETE POST-DILATATION, WHEN THE BALLOON WAS INFLATED TO 24 ATMOSPHERES (ATM) AND RUPTURED ON THE FIRST INFLATION. THE VIATRAC BDC WAS REMOVED AND THE ARMADA BDC WAS RE-INSERTED TO SUCCESSFULLY COMPLETE THE POST-DILATATION. THE STRETCHED ABSOLUTE SESS REMAINS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263263 ↗