Armada 1013455-200Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 3.0 mm x 200 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648206931), received between Jan 16, 2019 and Jul 28, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 reports).
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
- Material Rupture2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT POPLITEAL ARTERY WITH HEAVY CALCIFICATION AND 90% OCCLUSION. THE 3.0X200 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED TWICE TO 12 ATMOSPHERES AND RUPTURED. A NEW ARMADA PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17417993 ↗MalfunctionJan 16, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE 3.0X200 MM ARMADA 018 DILATATION CATHETER WAS ADVANCED TO THE HEAVILY CALCIFIED RIGHT POSTERIOR TIBIAL ARTERY WITHOUT INCIDENT. THE ARMADA WAS INFLATED TO 8 ATMOSPHERES AND RUPTURED WITH THE FIRST INFLATION. THE ARMADA WAS REMOVED IN ONE PIECE AND REPLACED WITH A 3.0X200 MM ARMADA 014 DILATATION CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8255012 ↗
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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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