Armada 1013460-020Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 6.0 mm x 20 mm x 90 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 08717648207389), received between Jun 29, 2023 and Jun 29, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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 Remove1
- Material Rupture1
- Material Separation1
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 29, 2023Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation
IT WAS REPORTED THAT THE ABDOMINAL AORTIC PROCEDURE WAS A LESION IN THE SUPERIOR MESENTERIC ARTERY (SMA). A NON-ABBOTT STENT WAS IMPLANTED, THEN THE ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED PROXIMAL TO THE IMPLANTED STENT IN THE SMA. THE THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON REPORTEDLY RUPTURED DURING INFLATION THE 2ND INFLATION AT 8 ATMOSPHERES (ATM) DUE TO BEING CAUGHT ON THE PREVIOUSLY IMPLANTED STENT. THE MARKER BAND OF THE BDC WAS ALSO NOTED TO HAVE BECOME SEPARATED DURING THE RUPTURE; HOWEVER, THE BDC INCLUDING THE SEPARATED MARKER BAND WAS REPORTEDLY REMOVED WITHOUT ISSUE AND ONLY SLIGHT RESISTANCE NOTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED DURING THE PROCEDURE. THE BDC WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17226209 ↗
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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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