Armada B1050-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648154638), received between Apr 11, 2022 and May 31, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2024Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE RECANALIZATION PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH STENOSIS AND CALCIFICATION. THE 5.0X100MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND INFLATED ONCE AT 8 ATMOSPHERES (ATMS). THE BALLOON WAS DEFLATED; HOWEVER, GOT STUCK IN THE 6FRENCH (F) INTRODUCER AND COULD NOT BE REMOVED. NO FORCE WAS APPLIED. THE BALLOON SEPARATED AND A PORTION REMAINED IN THE ANATOMY. A RIGHT FEMOROPOPLITEAL BYPASS UNDER ANESTHESIA WAS PERFORMED TO REMOVE THE SEPARATED PORTION OF THE BALLOON WHICH CAUSED A DELAY. NOTHING REMAINS IN THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELAE. THERE WAS ADDITIONAL HOSPITALIZATION FOR THE PATIENT. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: CALCIFICATION WAS MODERATE TO HEAVY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19440541 ↗
• MalfunctionDec 2, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 5.00X100MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED IN A PROCEDURE AND A HUB LEAK WAS NOTED; THEREFORE THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NOT CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15901629 ↗
• MalfunctionApr 11, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. AN ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION BUT IT WAS NOTED THAT THE DISTAL MARKER WAS MISSING. THEREFORE, ANOTHER ARMADA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073727 ↗