Armada A1040-040Recalls & reported problems
Abbott Vascular Inc. · Armada 14 PTA Catheter 4.0 mm x 40 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648155857), received between Mar 6, 2025 and Mar 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED INTERNAL MESENTERIC ARTERY (IMA). A .014 SUPRACORE GUIDE WIRE WAS PLACED IN THE IMA. A 3X20MM ARMADA 14 BALLOON WAS USED TO PRE-DILATED THE LESION; HOWEVER, DID NOT OPEN THE LESION ENOUGH. THE 5.0X18MM HERCULINK STENT WAS ATTEMPTED TO BE ADVANCED BUT FAILED TO CROSS DUE TO ANATOMY. A 4.0X40MM ARMADA 14 BALLOON WAS ADVANCED WITHOUT ISSUE; HOWEVER, ONCE INFLATED THE BALLOON RUPTURED AT NOMINAL PRESSURE AND REMOVED FROM THE ANATOMY WITHOUT ISSUE. A NEW 4X20MM ARMADA 14 BALLOON WAS ADVANCED AND ONCE AT THE TARGET SITE INFLATED TO NOMINAL PRESSURE; HOWEVER, RUPTURED. DURING REMOVAL OF THE ARMADA 14 BALLOON RESISTANCE WAS FELT WITH ANATOMY; HOWEVER, WITH GENTLE TUG THE DEVICE WAS ABLE TO BE REMOVED. UNDER FLUOROSCOPY THE DISTAL TIP OF THE BALLOON WAS OBSERVED ON THE WIRE AND ON REMOVAL OF THE DEVICE THE TIP WAS NOTED TO REMAIN JAILED BY THE STENT. A 3.0X40MM, 4.0X40MM ARMADA 14, OTHER UNSPECIFIED BALLOON AND WITH THE SAME 5.0X18MM HERCULINK STENT WAS RE-INSERTED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21537470 ↗
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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 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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