Armada A1040-080Recalls & reported problems
Abbott Vascular Inc. · Armada 14 PTA Catheter 4.0 mm x 80 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 08717648155871), received between Feb 24, 2017 and Jul 9, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash2
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 9, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 95% STENOSED LESION IN THE DISTAL POPLITEAL ARTERY TIBIOPERONEAL (TP) TRUNK WITH HEAVY CALCIFICATION. THE 4X80MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS ATTEMPTED TO INFLATED; HOWEVER, THE BALLOON FAILED TO INFLATE. A LEAK WAS NOTED NEAR THE HUB OF THE BDC. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER ARMADA BDC WAS USED TO CONTINUE 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 22464301 ↗MalfunctionFeb 24, 2017Leak/Splash
IT WAS REPORTED THAT DURING PREDILATATION IN THE HEAVILY CALCIFIED, VERY STENOTIC, COMMON FEMORAL ARTERY, DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATM) FOR 30 SECONDS, A LEAK IN THE HUB WAS NOTICED. THE DEVICE WAS REMOVED AND REPLACED WITH A NON-ABBOTT BALLOON TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6356999 ↗
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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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