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Armada 1013469-080Recalls & reported problems

Abbott Vascular Inc. · Armada 18 PTA Catheter 5.5 mm x 80 mm x 150 cm / Over-The-Wire · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648208300), received between Jun 27, 2023 and Jun 27, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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

Device problems

  • Material Rupture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJun 27, 2023Material Rupture; Material Rupture

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 5.5X80MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER, DURING THE FIRST INFLATION THE BDC RUPTURED AT 10 ATMOSPHERES. THE PROCEDURE WAS CONTINUED WITH USE OF A SECOND SAME SIZE ARMADA. THERE WAS 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 17209955 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.