Armada 1013463-200Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 2.0 mm x 200 mm x 150 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 08717648207754), received between Feb 18, 2021 and Feb 17, 2022 — classified as 2 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Rupture1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE PROCEDURE WAS A BELOW THE KNEE INTERVENTION FOR AN UNSPECIFIED LESION. A 2X200MM ARMADA 18 BALLOON WAS USED SUCCESSFULLY IN THE BEGINNING OF THE PROCEDURE. ONCE REMOVED FROM THE ANATOMY, IT WAS NOTED THAT THE BALLOON WAS PARTLY TORN OFF FROM THE DELIVERY CATHETER (BUT STILL IN ONE PIECE REMAINING ON THE DELIVERY CATHETER). IT WAS DECIDED TO NOT USE THE BALLOON AGAIN AT THE END OF THE PROCEDURE AS PLANNED SO ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO RESISTANCE NOTED WHILE ADVANCING OR REMOVING THE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13554052 ↗MalfunctionFeb 18, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 2.0X200MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION AND INFLATED 1 TIME TO 13 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. A NON-ABBOTT DEVICE WAS THEN 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: Insufficient Information
MAUDE report 11346727 ↗
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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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