Armada A1040-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648155888), received between Jun 30, 2025 and Jun 30, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Material Rupture; Deformation Due to Compressive Stress; Difficult to Advance; Material Rupture; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT AN OCCLUDED, HEAVILY CALCIFIED, MILDLY TORTUOUS POPLITEAL ARTERY USING A 4GX25CM HI-TORQUE (HT) COMMAND 14 GUIDEWIRE AND A 2.0X20MM ARMADA 14 XT BALLOON DILATATION CATHETER (BDC). THE HT COMMAND GUIDEWIRE AND ARMADA 14 BDC STUCK TOGETHER DURING REMOVAL AND WERE WITHDRAWN AS ONE UNIT. A 4.0X120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BDC WAS TO BE USED IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS LEFT INTERIOR TIBIAL. DURING ADVANCEMENT OF THE ARMADA 14 PTA BDC, RESISTANCE WAS MET DUE TO ANATOMY. ONCE AT THE LESION, THE ARMADA 14 PTA BDC WAS INFLATED ONCE TO 6 ATMOSPHERES AND COLLAPSED ON ITSELF LIKE AN ACCORDION. THE PROCEDURE WAS TERMINATED AND IT IS UNKNOWN IF OTHER DEVICES WERE 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 22362266 ↗