Armada B2140-020Recalls & reported problems
Abbott Vascular Inc. · Armada 35 PTA Catheter 14 mm x 20 mm x 135 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 08717648155581), received between Jan 22, 2020 and Jan 22, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
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.
MalfunctionJan 22, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 14X20MM ARMADA 35 BALLOON WAS INFLATED AND RUPTURED AT AN UNSPECIFIED ATMOSPHERE. TWO OTHER UNSPECIFIED BALLOONS WERE USED BUT ALSO RUPTURED. A 4TH UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A DELAY OF LESS THAN 30 MINUTES WAS NOTED BUT NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED SUBSEQUENT TO FILING THE INITIAL MDR: THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AORTO ILIAC LESION. THE ACCOUNT CONFIRMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS DUE TO THE 30 MINUTE DELAY. ONLY ONE INFLATION AT 8 ATMOSPHERES WAS PERFORMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9618431 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.