Armada 1013470-020Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 6.0 mm x 20 mm x 150 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 08717648208386), received between Sep 24, 2018 and Sep 24, 2018 — 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
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.
MalfunctionSep 24, 2018Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 6X20MM ARMADA 18 BALLOON CATHETER WAS INFLATED ONE TIME TO NOMINAL PRESSURE FOR POST DILATATION. THE BALLOON CATHETER WAS FULLY DEFLATED AND AN ATTEMPT TO REMOVE IT WAS MADE; HOWEVER, IT BECAME CAUGHT IN THE PREVIOUSLY DEPLOYED STENT STRUTS. THE BALLOON CATHETER WAS MOVED FORWARD AND THEN WAS ABLE TO BE PULLED OUT WITH NO DAMAGE NOTED TO THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7903808 ↗
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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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