Armada 1013463-120Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 2.0 mm x 120 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 08717648207723), received between Mar 29, 2024 and Mar 29, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
- Stretched1
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, 2024Stretched; Difficult to Advance; Stretched; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE TIBIAL ARTERY WITH NO TORTUOSITY AND MODERATE CALCIFICATION. THE 2.0X120MM ARMADA 18 BALLOON DILATION CATHETER (BDC) WAS ADVANCED OVER A 0.018 GUIDE WIRE AND USED, THEN REMOVED FROM THE ANATOMY COMPLETELY. THE BDC WAS AGAIN ADVANCED OVER THE GUIDE WIRE BUT COULD NOT ADVANCE. THE GUIDE WIRE WAS CHANGED OUT HOWEVER, THE BDC STILL COULD NOT ADVANCE. A NEW ARMADA BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE INNER MEMBER OF THE DEVICE WAS STRETCHED; HOWEVER, ADDITIONAL FOLLOW UP WITH THE ACCOUNT INDICATED THE ACCOUNT WAS UNAWARE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19006585 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.