Armada 1013466-060Recalls & reported problems
Abbott Vascular Inc. · Armada 18 PTA Catheter 4.0 mm x 60 mm x 150 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648207969), received between Nov 14, 2019 and Jul 2, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (4 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
- Material Rupture4
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE TIBIAL ARTERY. THE 4X60MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 2 ATMOSPHERES (ATM). THEREFORE, THE BALLOON WAS REMOVED FROM THE PATIENT. A 4X40MM ARMADA BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19661633 ↗MalfunctionOct 20, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED POPLITEAL AND SUPERFICIAL FEMORAL ARTERY. THE 4.0X60MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT ATMOSPHERES (ATMS). A 5.5X150MM ARMADA 18 (BDC) RUPTURED DURING THE SECOND INFLATION AT 12ATMS. ANOTHER UNSPECIFIED ARMADA WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15640957 ↗MalfunctionFeb 11, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION IN THE LEFT LEG. A 4.0X60MM ARMADA 18 BALLOON RUPTURED AT 14 ATMOSPHERES AT AN UNKNOWN NUMBER OF INFLATION'S. ANOTHER UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9696305 ↗MalfunctionNov 14, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 4.0MM X 60MM X 150CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION. DURING THE THIRD INFLATION, TO 8 ATMOSPHERES, THE BALLOON RUPTURED. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9324271 ↗
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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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