Armada 1013458-060Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 5.0 mm x 60 mm x 90 cm / Over-The-Wire · Class 2
- 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 08717648207181), received between Jul 11, 2019 and Jul 11, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Misassembled” (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
- Component Misassembled1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2019Improper or Incorrect Procedure or Method; Component Misassembled; Improper or Incorrect Procedure or Method; Component Misassembled
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) THAT DID NOT HAVE ANY TORTUOUSITY. A 5.0 X 60 MM ARMADA 18 BALLOON CATHETER WAS USED AND WAS INFLATED TO NOMINAL PRESSURE. IT DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT; HOWEVER, IT WAS NOTED THAT THE DISTAL MARKER WAS LOCATED WITHIN THE BALLOON LENGTH AND NOT IN THE SHOULDER WHERE IT SHOULD HAVE BEEN. THERE WAS NO STRETCHING OR DAMAGE NOTED TO THE SHAFT OF THE CATHETER. THE SAME DEVICE WAS STILL USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8781476 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.