Armada A1020-120Recalls & reported problems
Abbott Vascular Inc. · Armada 14 PTA Catheter 2.0 mm x 120 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 08717648155703), received between Jan 10, 2017 and Jun 12, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Material Rupture1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED DURING THE PROCEDURAL PREPARATION OF A 2.0X120MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) THAT THE INNER PACKAGING OF THE DEVICE WAS NOTED TO HAVE A HOLE WHEN REMOVED FROM ITS PACKAGE. THEREFORE, ANOTHER BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22197256 ↗MalfunctionJan 10, 2017Material Rupture; Improper or Incorrect Procedure or Method
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUDED DE NOVO LESION WITH HEAVY CALCIFICATION IN THE MID ANTERIOR TIBIAL ARTERY. THE 2.0X120MM ARMADA 14 BALLOON CATHETER WAS NOT PREPPED OUTSIDE THE ANATOMY PRIOR TO USE. THE CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE; HOWEVER, LOSS OF GAUGE PRESSURE WAS NOTED. THE BALLOON HAD RUPTURED AT 10 ATMOSPHERE (ATM) DURING THE 1ST INFLATION. A NEW 2.0X120MM ARMADA 14 BALLOON CATHETER WAS USED IN THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6238874 ↗
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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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