Armada B1040-120Recalls & reported problems
Abbott Vascular Inc. · Armada 35 PTA Catheter 4 mm x 120 mm x 80 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 08717648154553), received between Jul 29, 2019 and Jan 6, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2026Leak/Splash
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION. THE 4X120MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS INSERTED INTO THE PATIENT; HOWEVER, PRIOR TO INFLATION A LEAK WAS NOTED AS BLOOD BEGAN TO DRAW BACK FROM THE HUB OF THE DEVICE. THEREFORE, THE BDC WAS REMOVED AND ANOTHER ARMADA 35 BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE 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 23977645 ↗MalfunctionJul 29, 2019Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT BEFORE USE, THERE WAS DIFFICULTY IN REMOVING THE PROTECTIVE SHEATH FROM A 4.0 X 120 MM ARMADA 35 BALLOON CATHETER. HOWEVER, IT WAS REPLACED WITH AN UNSPECIFIED DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8837120 ↗
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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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