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Armada 1013463-040Recalls & reported problems

Abbott Vascular Inc. · Armada 18 PTA Catheter 2.0 mm x 40 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 08717648207686), received between Apr 21, 2022 and Apr 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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

  • Unsealed Device Packaging1

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.

  • MalfunctionApr 21, 2022Unsealed Device Packaging; Unsealed Device Packaging

    IT WAS REPORTED THAT DURING UN-PACKAGING OF THE 2.0 X 40 MM ARMADA 18 BALLOON CATHETER, THE TYVEK POUCH WAS ALREADY OPENED. THE EXTERNAL BOX WAS NOT DAMAGED OR CRUSHED. THE BALLOON CATHETER WAS NOT USED, AND A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14168017 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

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