Armada 1013466-080Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 4.0 mm x 80 mm x 150 cm / Over-The-Wire · Class 2
Data updated Oct 13, 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 08717648207976), received between Aug 5, 2019 and Aug 5, 2019 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash1
- Material Split, Cut or Torn1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2019Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING PREPARATION OF A 4.0 X 80 MM ARMADA 18 BALLOON DILATATION CATHETER (BDC), THE BALLOON DID NOT HOLD NEGATIVE. THERE WAS A HOLE NOTED ON THE BALLOON. THE DEVICE WAS NOT USED AND WAS REPLACED WITH ANOTHER ARMADA 18 BDC. THERE WAS NO ISSUE REMOVING THE PROTECTIVE SHEATH. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8861814 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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