Armada 1013468-080Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 5.0 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 08717648208195), received between Jun 7, 2022 and Jun 7, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Improper or Incorrect Procedure or Method1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2022Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED VESSEL WITHOUT TORTUOSITY IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE ARMADA 18 BALLOON CATHETER WAS SOAKED PRIOR TO USE AND WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY. THERE WAS MILD RESISTANCE DURING ADVANCEMENT DUE TO THE ANATOMY. THE BALLOON WAS INFLATED AT 14 ATMOSPHERES (ATMS) FOR THE FIRST INFLATION. HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 16 ATMS. A 5.5X100MM ARMADA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14621560 ↗
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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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