Armada B2140-060Recalls & reported problems
Abbott Vascular Inc. · Armada 35 PTA Catheter 14 mm x 60 mm x 135 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 08717648155604), received between Oct 15, 2019 and Oct 20, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 reports).
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
- Material Rupture2
- Difficult to Advance1
- Inflation Problem1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2019Inflation Problem; Material Rupture; Difficult to Advance; Inflation Problem; Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION WITH 50% STENOSIS LOCATED IN A MODERATELY TORTUOUS, MODERATELY CALCIFIED RIGHT COMMON ILLIAC ARTERY. A 14X60MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED WITH RESISTANCE MET WITH THE ANATOMY BUT ULTIMATELY REACHED THE LESION AND WAS INFLATED. BEFORE THE BALLOON REACHED 4 ATMOSPHERES (ATM), AT ABOUT 3 ATM, THE BALLOON RUPTURED. INFLATION HAD BEEN NOTED AS SLOW. ANOTHER SAME SIZE ARMADA 35 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9212550 ↗MalfunctionOct 15, 2019Material Rupture; Material Separation; Material Rupture; Material Separation
IT WAS REPORTED THAT THE ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED AT 3 ATMOSPHERES (ATM). THE BALLOON ALSO SEPARATED FROM THE CATHETER. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9194776 ↗
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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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