Armada B2050-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648155161), received between Dec 4, 2019 and Jun 26, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

• MalfunctionJun 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CALCIFIED POPLITEAL ARTERY WITH 80% STENOSIS. THE ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOGPLASTY (PTA) CATHETER RUPTURED AT 6 ATMOSPHERES. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10202350 ↗
• MalfunctionFeb 19, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THREE ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS (5X200MM, 5X20MM, 6X200MM) AND TWO ABSOLUTE PRO SELF-EXPANDING STENT SYSTEMS (SESS) (6X150MM, 6X60MM) WERE RECEIVED BY THE CUSTOMER WITH BLOOD MARKS ON THE OUTSIDE PACKAGING. THE DEVICES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9727319 ↗
• MalfunctionDec 4, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TREATING THE LEFT SUBCLAVIAN ARTERY, MODERATELY CALCIFIED LESION. THE ARMADA DILATATION CATHETER ADVANCED TO THE LESION AND BALLOON INFLATION WAS PERFORMED WITHOUT REPORTED ISSUES. FOLLOWING, THE BALLOON FAILED TO DEFLATE. TWO DIFFERENT SYRINGES (10CC AND 3CC) WERE USED TO MANUALLY DEFLATE THE BALLOON. THE BALLOON EVENTUALLY DEFLATED, EXTREMELY SLOWLY (APPROXIMATELY 10 MINUTES). THE DEVICE WAS REMOVED WITHOUT FURTHER ISSUES. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9413128 ↗