Armada 1013468-060Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 5.0 mm x 60 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 08717648208188), received between Jul 3, 2018 and Aug 26, 2021 — classified as 2 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Difficult to Advance1
- Leak/Splash1
- 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.
MalfunctionAug 26, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED AND HEAVILY CALCIFIED VESSEL IN THE PERONEAL TRUNK. THE 5.0X60MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON BURST ON THE FIRST INFLATION AT 8 ATMOSPHERES (ATMS). ANOTHER ARMADA 18 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION IS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12374272 ↗MalfunctionJul 3, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE ARMADA 18 WAS INFLATED TO 8 ATMOSPHERES AT THE HEAVILY CALCIFIED, LEFT OSTIAL SUPERFICIAL FEMORAL ARTERY, BUT THE PRESSURE IN THE INDEFLATOR WAS SLOWLY LOSING PRESSURE. CONTRAST WAS NOTED LEAKING FROM THE HUB OF THE ARMADA 18, BUT THE LESION WAS SUCCESSFULLY TREATED AT NOMINAL PRESSURE FOR THIRTY SECONDS TO ONE MINUTE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7661267 ↗
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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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