Armada B2090-020Recalls & reported problems
Abbott Vascular Inc. · Armada 35 PTA Catheter 9 mm x 20 mm x 135 cm / Over-The-Wire · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 08717648155468), received between Mar 26, 2026 and Mar 26, 2026 — 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.
Reports received per month
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.
MalfunctionMar 26, 2026Material Rupture
IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED AND 75% STENOSED ILIAC ARTERY. AN ARMADA 35 9.0 MM X 20 MM X 135 CM BALLOON DILATATION CATHETER WAS INSERTED AND ADVANCED. HOWEVER, AFTER THE SECOND INFLATION (6ATM), A L LEAK OF CONTRAST WAS OBSERVED. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER BALLOON. 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 24701291 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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