Armada 1013464-080Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 2.5 mm x 80 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 08717648207792), received between Jul 24, 2023 and Oct 23, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A SEVERELY STENOSED LESION IN A TIBIAL VESSEL. A 2.5X80MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES; HOWEVER, DURING THE SECOND INFLATION TO 14ATMS THE BALLOON WAS NOTED TO RUPTURE. THEREFORE, THE BDC WAS REPLACED WITH ANOTHER ARMADA BDC AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23375733 ↗MalfunctionJul 24, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. THE 2.5X80MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS PREPPED PRIOR TO USE THE WITHOUT ISSUE. THE BDC WAS ADVANCED TO THE TARGET LESION AND MILD RESISTANCE WAS NOTED. THE BALLOON RUPTURED DURING FIRST INFLATION AT APPROXIMATELY 2 ATMOSPHERES. ANOTHER ARMADA BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17380107 ↗
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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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