Armada F2012-012Recalls & reported problems
Abbott Vascular Inc. · Armada 14 XT PTA Catheter 1.2 mm x 12 mm x 145 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 08717648182815), received between Dec 18, 2024 and Aug 11, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove2
- Deflation Problem1
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.
MalfunctionAug 11, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE ANTERIOR TIBIAL ARTERY. A 1.2X12MM ARMADA 14 XT BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO NOTED ISSUES AND DILATED, ONCE, TO 6ATMS; HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON, IT WAS NOTED TO NOT DEFLATE PROPERLY. ADDITIONALLY, THE BDC BECAME STUCK ON THE GUIDE WIRE. AFTER BEING HELD AT NEGATIVE PRESSURE FOR 50 SECONDS THE BALLOON WAS ABLE TO DEFLATE AND THE BDC WAS REMOVED, AND A NEW ARMADA 14 BDC WAS USED AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22778079 ↗MalfunctionDec 18, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PERONEAL ARTERY WITH SEVERE CALCIFICATION AND NO TORTUOSITY. AFTER INFLATION OF THE 1.2X12MM ARMADA BALLOON DILATATION CATHETER (BDC), THE BDC COULD NOT MOVE ON THE UNSPECIFIED HT WINN GUIDE WIRE. THEREFORE, BOTH DEVICES WERE WITHDRAWN AS A SINGLE UNIT. ANOTHER BALLOON AND GUIDEWIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20967195 ↗
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