Armada 1013466-020Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 4.0 mm x 20 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 08717648207945), received between Aug 13, 2019 and Aug 13, 2019 — 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. How this data works · Data updated Oct 13, 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.
MalfunctionAug 13, 2019Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS ANTERIOR TIBIAL ARTERY. THERE WAS RESISTANCE WHILE ATTEMPTING TO REMOVE THE 4.0X20MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) OVER THE COMMAND 18 GUIDE WIRE. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. AFTER REMOVAL, IT WAS NOTED THAT THE GUIDE WIRE POLYMER WAS TORN AT THE TIP. A NEW UNSPECIFIED GUIDE WIRE AND A NEW UNSPECIFIED BDC WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 8888375 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.