Armada 1013456-040Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 4.0 mm x 40 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 08717648206955), received between Nov 27, 2017 and Nov 27, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
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.
MalfunctionNov 27, 2017Leak/Splash
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT FISTULA. THE ARMADA 18 4.0 MM/ 40 MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON LEAKED AT THE HUB DURING INFLATION. A SECOND ARMADA BALLOON WAS USED TO COMPLETE THE PROCEDURE WITH GOOD RESULT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE EFFECTS. IT WAS STATED THAT THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7061064 ↗
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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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