Armada B2040-150Recalls & reported problems
Abbott Vascular Inc. · Armada 35 LL PTA Catheter 4 mm x 150 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 08717648155130), received between Feb 3, 2017 and Jul 13, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash2
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 4.00X150MM ARMADA BALLOON DILATATION CATHETER(BDC) WAS ATTEMPTED TO BE INFLATED, BUT THE BALLOON WAS ONLY ABLE TO PARTIALLY INFLATE AND A CONTRAST LEAK WAS NOTED NEAR THE SHAFT OF THE BALLOON CATHETER. NEGATIVE PRESSURE WAS APPLIED AND THE BDC WAS REMOVED FORM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE BDC WAS NOTED TO BE PREPPED (AIR ASPIRATION) PRIOR TO USE. ANOTHER SAME SIZE BALLOON WAS USED IN THE PROCEDURE WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15009362 ↗MalfunctionFeb 3, 2017Leak/Splash
IT WAS REPORTED THAT A 4.0 X 150 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS SELECTED FOR THE PROCEDURE. THE PREPARATION OF THE PTA CATHETER FOR USE COULD NOT BE COMPLETED DUE TO THE DEVICE LEAKING. THE DEVICE WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 6302580 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 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.
How reports and recalls are matched · Editorial policy · Report an error on this page