Armada B1050-150Recalls & reported problems
Abbott Vascular Inc. · Armada 35 LL PTA Catheter 5 mm x 150 mm x 80 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648154652), received between Feb 3, 2020 and Oct 24, 2022 — classified as 1 injury, 1 malfunction.
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
- Difficult to Remove1
- Material Rupture1
- Material Separation1
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.
MalfunctionOct 24, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance
IT WAS REPORTED THAT DURING AN INTERVENTION, THE ARMADA 35 BALLOON RUPTURED WHEN IT WAS INFLATED TO NOMINAL PRESSURE ONLY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15660524 ↗InjuryFeb 3, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE 5.0X150MM ARMADA 35 BALLOON DILATATION CATHETER MET RESISTANCE WITH THE ANATOMY DURING RETRIEVAL AND THE BALLOON SEPARATED IN THE PATIENT. A CUT DOWN SURGERY WAS PERFORMED TO RETRIEVE THE SEPARATED DISTAL PORTION OF THE BALLOON. THE LESION WAS TREATED VIA ENDARTERECTOMY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9661461 ↗
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- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
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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