Armada B1040-100Recalls & reported problems
Abbott Vascular Inc. · Armada 35 PTA Catheter 4 mm x 100 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 08717648154546), received between Dec 23, 2020 and May 26, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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.
Most reported problems
Device problems
- Leak/Splash1
- Material Rupture1
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.
MalfunctionMay 26, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A 4X100MM ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED. 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 11890646 ↗MalfunctionDec 23, 2020Leak/Splash; Leak/Splash
DURING THE DEVICE PREPARATION OF A 4 X 100MM ARMADA 35, IT WAS NOTED THAT MORE AIR BUBBLES WERE OBSERVED THAN USUAL DURING AIR ASPIRATION. THE PHYSICIAN STOPPED USING THE DEVICE SUSPECTING THE POSSIBILITY OF A LEAK. THE ARMADA 35 WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER ARMADA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 11067440 ↗
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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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