Armada A1040-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648155840), received between Nov 19, 2021 and Mar 6, 2025 — classified as 1 injury, 1 malfunction.

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

• InjuryMar 6, 2025Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  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 INFORM

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21537669 ↗
• MalfunctionNov 19, 2021Break; Leak/Splash; Improper or Incorrect Procedure or Method; Break; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, IT WAS NOTED THAT THE 4X20MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) COULD NOT HOLD PRESSURE. THE DEVICE WAS THEN ADVANCED TO THE 99% STENOSED LESION IN THE ILIAC ARTERY. INFLATION WAS ATTEMPTED IN THE ANATOMY AND DURING INFLATION, IT WAS NOTED THAT THE DEVICE COULD NOT HOLD PRESSURE. THE BDC WAS REMOVED, AND THE HUB WAS NOTED AS CRACKED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849552 ↗