Armada B1070-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648154829), received between Mar 12, 2021 and Jul 25, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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.

• MalfunctionJul 25, 2022Failure to Fold; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Failure to Fold; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT COMMON FEMORAL ARTERY AND EXTERNAL ILIAC ARTERY THAT WAS HEAVILY CALCIFIED. IT IS POSSIBLE THAT THE THE ARMADA 35 BALLOON CATHETER CONTAINED A HIGHER THAN OPTIMAL CONCENTRATION OF CONTRAST. THE BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION AND ON THE FIRST INFLATION AT NOMINAL, THE BALLOON RUPTURED. THE BALLOON WOULD NOT RE-WRAP ADEQUATELY AND DURING REMOVAL, THE BALLOON BECAME STUCK TO THE 6FR SHEATH AND THE DISTAL END TORE. WITHOUT FURTHER INTERVENTION, THE TORN END OF THE BALLOON WAS PULLED INTO THE DILATOR OF THE SHORT (ACCESS) 6FR SHEATH AS THE WIRE WAS PULLED BACK. THE WIRE REMAINED IN THE PATIENT FOR FURTHER PLANNED INTERVENTION. THE SHEATH WAS REPLACED AND FURTHER ANGIOPLASTY AND STENTING OCCURRED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099623 ↗
• InjuryMar 28, 2022Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED ARTERIAL LESION IN THE LOWER LIMB. THE 7X120 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED TO NOMINAL PRESSURE AND THE BALLOON RUPTURED. IT WAS NOT POSSIBLE TO REMOVE THE BALLOON WITHOUT REMOVING THE INTRODUCER SHEATH AND THEN THE BALLOON RUPTURED [SEPARATED]. THE BALLOON WAS RETRIEVED IN AN UNSPECIFIED MANNER AND A LARGE INTRODUCER SHEATH WAS POSITIONED TO REDUCE THE ABUNDANT BLEEDING AND TO CONTROL THE RIGHT FEMORAL ACCESS. A MANUAL COMPRESSION WAS APPLIED. THERE WAS A LARGE BLEEDING AND IT WAS NOT CONFIRMED IF A BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT WILL BE FOLLOWED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13928762 ↗
• InjuryMar 12, 2021Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY, AND 80% STENOSIS IN THE FEMORAL ARTERY. REPORTEDLY, A 6.0 X 100 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR DILATATION; HOWEVER, RESISTANCE WAS FELT DUE TO THE ANATOMY AND THE BALLOON RUPTURED DURING FIRST INFLATION AT NOMINAL PRESSURE. DURING REMOVAL, RESISTANCE WAS NOTED WITH THE SHEATH AND THE DISTAL PART OF THE BALLOON SEPARATED AND REMAINED IN THE ARTERY. AN ABSOLUTE STENT WAS DEPLOYED TO COVER (EMBED) THE SEPARATED BALLOON MATERIAL TO AVOID DISTAL EMBOLIZATION. A NEW 7.0 X 120 MM ARMADA 35 BDC WAS THEN ADVANCED TO EXPAND THE STENT BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT NOMINAL PRESSURE. ON REMOVAL, RESISTANCE WAS NOTED WITH THE SHEATH AND THE DISTAL PART OF THE BALLOON SEPARATED AND REMAINED IN THE ARTERY. ANOTHER ABSOLUTE STENT WAS DEPLOYED TO COVER (EMBED) THE SEPARATED BALLOON MATERIAL. AN UNSPECIFIED BDC WAS THEN USED AND THE TARGET LESION WAS TREATED. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11477783 ↗