Armada A1025-120Recalls & reported problems
Abbott Vascular Inc. · Armada 14 PTA Catheter 2.5 mm x 120 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
- 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 08717648155765), received between May 1, 2024 and May 1, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (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.
Reports received per month
Most reported problems
Device problems
- Deflation Problem1
- Difficult to Remove1
- Material Twisted/Bent1
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.
MalfunctionMay 1, 2024Deflation Problem; Difficult to Remove; Material Twisted/Bent; Deflation Problem; Difficult to Remove; Material Twisted/Bent
IT WAS REPORTED THAT THE PROCEDURE WAS TO PERFORM RECANALIZATION AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE LOWER LEFT LEG USING THE ANTEGRADE APPROACH. THREE ARMADA BALLOON DILATATION CATHETERS (BDC) WERE ATTEMPTED TO BE USED IN THE PROCEDURE; HOWEVER, TWO OF THE ARMADA BALLOONS FAILED TO DEFLATE PROPERLY AND BOTH WERE DIFFICULT TO REMOVE. AFTER REMOVAL, THE BALLOONS WERE NOTED TO BE TWISTED. IN THE PHYSICIAN OPINION THE MATERIAL OF THE PTA BALLOONS IS WEAKER CAUSING BALLOON TWISTING [TORSION]. A THIRD ARMADA BDC WAS ATTEMPTED TO BE USED IN THE PROCEDURE; HOWEVER, THE BALLOON WAS NOTED TO HAVE A LEAK AT THE HUB. ANOTHER ARMADA 14 BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19222985 ↗
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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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