Armada A1020-200Recalls & reported problems
Abbott Vascular Inc. · Armada 14 PTA Catheter 2.0 mm x 200 mm x 90 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 08717648155710), received between Mar 29, 2023 and Mar 29, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Failure to Advance1
- Material Separation1
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.
MalfunctionMar 29, 2023Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS TIBIAL ANTERIOR ARTERY. THE 2.0X200MM ARMADA 14 BALLOON DILATATION CATHETER FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS NOTED WITH ANATOMY DURING REMOVAL THE PROXIMAL SHAFT SEPARATED. THE SEPARATED PORTION WAS RETRIEVED WHEN THE GUIDE WIRE WAS REMOVED. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16639705 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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