Armada 1013470-180Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 6.0 mm x 180 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 08717648208454), received between Oct 1, 2021 and Oct 1, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
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.
MalfunctionOct 1, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0 X 150 MM ARMADA DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT DIFFICULTY. ON THE FIRST INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. THE 6.0 X 180 MM ARMADA DILATATION CATHETER WAS THEN ADVANCED TO THE TARGET LESION WITHOUT DIFFICULTY; HOWEVER, ON THE FIRST INFLATION, THIS DEVICE ALSO RUPTURED AT 8 ATM. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE.. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12564097 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.