Armada 1013468-020Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 5.0 mm x 20 mm x 150 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 08717648208164), received between Jul 6, 2017 and Oct 25, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deflate” (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
- Failure to Deflate1
- Improper or Incorrect Procedure or Method1
- Material Rupture1
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.
MalfunctionOct 25, 2022Improper or Incorrect Procedure or Method; Failure to Deflate; Improper or Incorrect Procedure or Method; Failure to Deflate
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE TIBIO-PERONEAL TRUNK. THE 5.0X20MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WOULD NOT DEFLATE WITH FIRST INFLATION AT 8 ATMOSPHERES. THEREFORE, IT WAS WITHDRAWN WHILE INFLATED AND NOTED TO GO THROUGH SHEATH WITHOUT ISSUE. THERE WERE NO PATIENT EFFECTS AND NO SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15670607 ↗MalfunctionJul 6, 2017Material Rupture
IT WAS REPORTED THAT FOLLOWING ATHERECTOMY, AN ARMADA DILATATION CATHETER WAS ADVANCED TO THE MILDLY TORTUOUS, HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY LESION WITHOUT ISSUE. DILATATION WAS ATTEMPTED, HOWEVER, CONTRAST WAS SEEN AND A BALLOON PINHOLE WAS SUSPECTED. THE DEVICE WAS REMOVED WITHOUT ISSUE AND ANOTHER DEVICE WAS USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6691829 ↗
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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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