Armada A1030-060Recalls & reported problems
Abbott Vascular Inc. · Armada 14 PTA Catheter 3.0 mm x 60 mm x 90 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 08717648155802), received between Oct 10, 2022 and Jun 28, 2024 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
- Difficult to Remove1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING PREPARATION OF THE 3.0X60MM ARMADA 14 BALLOON DILATATION CATHETER, IT WAS NOTED THE BALLOON WAS PERFORATED. ANOTHER ARMADA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19631851 ↗MalfunctionOct 10, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED TIBIAL ARTERY THAT IS 90% STENOSED. THE 014 HT COMMAND GUIDE WIRE CROSSED LESION SUCCESSFULLY. THE 3.0X60MM ARMADA 14 BALLOON DILATATION CATHETER WAS ADVANCED AND USED TO PRE-DILATE THE LESION SUCCESSFULLY EVEN THOUGH RESISTANCE WAS MET DURING ADVANCEMENT WITH THE GUIDE WIRE. ONCE REMOVED THE 4.0X38MM XIENCE PRIME STENT DELIVERY SYSTEM WAS ATTEMPTED TO ADVANCE OVER THE WIRE; HOWEVER, RESISTANCE WAS MET WITH THE GUIDE WIRE. THE SAME ARMADA 14 BALLOON WAS ATTEMPTED TO BE ADVANCED OVER THE GUIDE WIRE, BUT MET RESISTANCE WAS NOTED AGAIN. THE BALLOON AND GUIDE WIRE WERE REMOVED TOGETHER. THE GUIDE WIRE WAS REMOVED AND THE COATING WAS NOTED TO BE PEELED BUT REMAINING ON THE GUIDE WIRE. ANOTHER COMMAND GUIDE WIRE AND XIENCE PRIME WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15571248 ↗
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