Armada A1020-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648155697), received between Mar 8, 2021 and Mar 8, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 8, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION BEHIND THE KNEE (BTK) WITH TOTAL OCCLUSION. THE COMMAND GUIDE WIRE (GW) WAS ADVANCED TO THE LESION WITH THE SUPPORT OF A 2.0X80MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER; HOWEVER, THE GW COULD NOT CROSS AND BECAME STUCK IN THE OCCLUSION AFTER ATTEMPTING TO GO FURTHER SUBINTIMAL. THE TIP OF THE COMMAND GW SEPARATED IN THE ANTERIOR TIBIAL ARTERY AND NO ATTEMPT WAS MADE TO RETRIEVE THE TIP. THE ARMADA 14 WAS INFLATED TO A MAXIMUM OF 7 ATMOSPHERES. NO RUPTURE NOTED, BUT A TEAR IN THE TIP OF THE ARMADA 14 FROM THE TIP TO THE BEGINNING OF THE BALLOON WAS NOTED AND WAS DUE TO BEING ADVANCED WITH THE COMMAND GUIDE WIRE IN THE HEAVILY CALCIFIED LESION. A WINN GUIDE WIRE WAS ABLE TO CROSS THE LESION BUT NO OTHER DEVICE, INCLUDING A 2.0X120 MM ARMADA, A 2.0X20 MM ARMADA XT AND A NON-ABBOTT BALLOON WAS ABLE TO CROSS DESPITE THE USE OF A NON-ABBOTT LONG INTRODUCER SHEATH. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11440102 ↗