Armada 1013466-150Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 4.0 mm x 150 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 08717648208003), received between Nov 29, 2017 and Nov 29, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 29, 2017Leak/Splash
IT WAS REPORTED THAT DURING PREPARATION OF THE 4.0X150 ARMADA 18 BALLOON CATHETER, A LEAK WAS NOTED IN THE BALLOON. THE DEVICE WAS SET ASIDE AND A NEW BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 7067186 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.