Armada B2080-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648155420), received between Dec 8, 2017 and Nov 4, 2025 — classified as 3 malfunctions.

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

• MalfunctionNov 4, 2025Break; Leak/Splash; Break; Leak/Splash

  IT WAS NOTED THAT DURING PREPARATION, THE HUB OF AN 8.0X20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS NOTED TO BE CRACKED AND A LEAK WAS OBSERVED AS THE BALLOON WOULD NOT INFLATE. A NEW ARMADA BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466647 ↗
• MalfunctionMar 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) HOWEVER RESISTANCE WAS MET GETTING TO THE LESION THROUGH THE LEFT FEMORAL ARTERY. THE 8.0X20MM ARMADA 35 BALLOON DILATATION CATHETER WAS USED IN AN ATTEMPT TO DILATE THE ARTERY HOWEVER THE BALLOON RUPTURED AT 14 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13789136 ↗
• MalfunctionDec 8, 2017Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, LESION IN THE ILIAC ARTERY. THE 8MM X 20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED IN THE PATIENT ANATOMY WITHOUT RESISTANCE. DURING INFLATION, THE BALLOON ONLY PARTIALLY INFLATED TO 2 ATMOSPHERES. THE ARMADA 35 BDC WAS DEFLATED WITHOUT ISSUE AND WAS REMOVED FROM THE PATIENT ANATOMY. ANOTHER ARMADA 35 BDC WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS DOING FINE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7100780 ↗