Armada A1020-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648155666), received between Apr 7, 2021 and Feb 16, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2023Material Rupture; Material Rupture

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN THE PROXIMAL TRUNCUS COELIACUS. TWO ARMADA 14 BALLOON DILATATION CATHETERS, SIZES 2.0X20MM AND 3.0X20MM, WERE USED TO PREDILATE THE CELIAC TRUNK BUT RUPTURED DURING THE FIRST INFLATION AT NOMINAL PRESSURE DUE TO THE SEVERE CALCIFICATION OF THE TARGET LESION. AN ARMADA 18, 5X20 MM, BALLOON DILATATION CATHETER WAS USED TO DILATE THE TARGET LESION AND A 7.0X18 MM RX HERCULINK ELITE STENT WAS SUCCESSFULLY IMPLANTED IN THE CELIAC TRUNK. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16393077 ↗
• MalfunctionApr 7, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A COMMON ILIAC ARTERY. A 2.0X20MM ARMADA 14 WAS ATTEMPTED TO TO BE INFLATED; HOWEVER, IT ONLY PARTIALLY INFLATED. A LEAK WAS NOTED ON THE JOINT BETWEEN THE HUB AND THE SHAFT DURING THE FIRST INFLATION. ANOTHER NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629607 ↗