Skip to content

Armada B2030-040Recalls & reported problems

Abbott Vascular Inc. · Armada 35 PTA Catheter 3 mm x 40 mm x 135 cm / Over-The-Wire · Class 2

All models of Armada (213)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 08717648155062), received between Jan 5, 2017 and Jan 5, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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

Device problems

  • Inflation Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJan 5, 2017Inflation Problem

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE TIBIAL PERONEAL TRUNK WITH MILD CALCIFICATION. RESISTANCE WAS NOT FELT DURING ADVANCEMENT OF THE 3 X 40 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) AND IT CROSSED THE LESION SUCCESSFULLY; HOWEVER, THE BALLOON DID NOT INFLATE PROPERLY AND WAS REMOVED WITHOUT ISSUE FROM THE ANATOMY. A REPLACEMENT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6226583 ↗

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page