Armada B2100-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648155529), received between Dec 15, 2021 and Dec 9, 2025 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (3 reports).

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.

• DeathDec 9, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LEFT SUBCLAVIAN ARTERY AND CEPHALIC VEIN. THE 10X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, DURING RETRACTION OF THE BDC RESISTANCE WAS NOTED AND THE BALLOON DISLODGED FROM THE BDC SHAFT INSIDE THE PATIENT. A SNARE WAS USED TO REMOVE THE DISLODGED BALLOON WAS REMOVED FROM THE PATIENT. THERE WAS A CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. POST PROCEDURE THE PATIENT REPORTEDLY DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23759420 ↗
• InjuryJan 6, 2022Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RE-THROMBOSED STENT. AFTER THE 10X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION, AND AFTER SEVERAL INFLATIONS OF THE BALLOON, BETWEEN NOMINAL PRESSURE AND ABOVE NOMINAL, THE BALLOON RUPTURED. IT WAS NOTED THE RUPTURE OCCURRED DUE TO THE PREVIOUSLY IMPLANTED STENT HAD FRACTURED AND CAUSED THE BALLOON TO RUPTURE ON CONTACT. DURING REMOVAL OF THE BDC RESISTANCE WAS MET WITH THE INTRODUCER AND THE CENTRAL SHEATH OF THE BALLOON SEPARATED. IT WAS NOTED ANOTHER UNSPECIFIED ARMADA 35 BDC WAS ADVANCED; HOWEVER, THE SAME EXACT ISSUE OCCURRED AND BDC RUPTURED AT AN UNKNOWN PRESSURE. THEREFORE, TWO FRAGMENTS REMAINED IN THE ANATOMY AND THE FRAGMENTS WERE PRESSED AGAINST THE VASCULAR WALL. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13177583 ↗
• InjuryDec 15, 2021Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A HEAVILY CALCIFIED RE-THROMBOSED STENT, AFTER THE 10X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION, AND AFTER SEVERAL INFLATIONS OF THE BALLOON, BETWEEN NOMINAL PRESSURE AND ABOVE NOMINAL PRESSURE, THE BALLOON RUPTURED WITH ONE FRAGMENT SEPARATING FROM THE DEVICE. RESISTANCE WAS NOTED WHEN PULLING THE BDC BACK INTO THE INTRODUCER SHEATH. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE BALLOON FRAGMENT FROM THE PATIENT ANATOMY, WHICH WAS SUCCESSFULLY REMOVED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014690 ↗