Armada B1060-200Recalls & reported problems
Abbott Vascular Inc. · Armada 35 LL PTA Catheter 6 mm x 200 mm x 80 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648154751), received between May 22, 2025 and May 22, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT ID: (B)(6). IT WAS REPORTED THAT THIS WAS A PROCEDURE PERFORMED TO TREAT A TARGET LESION IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY. DURING THE PROCEDURE, A DISSECTION WAS CAUSED BY THE 6.0X200 MM ARMADA 35 LL BALLOON DILATATION CATHETER. THE DISSECTION WAS TREATED WITH A STENT DURING THE SAME PROCEDURE. THE CONDITION RESOLVED WITH NO ADVERSE SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Vascular Dissection
MAUDE report 22073972 ↗
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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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