Armada B1100-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648154966), received between Mar 13, 2018 and Oct 17, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2024Difficult to Remove; Material Rupture; Material Separation; Stretched; Difficult to Remove; Material Rupture; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS FISTULA WITH 80-90% STENOSIS. THE 10X80 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED FOUR TIMES TO NOMINAL PRESSURE IN A STENOSED NON-ABBOTT STENT AND RUPTURED ON THE FOURTH INFLATION. THE BALLOON WAS DEFLATED, AND NEGATIVE PRESSURE WAS HELD FOR MORE THAN 20 SECONDS, BUT THERE WAS DIFFICULTY REMOVING THE BALLOON. THE BALLOON WAS REMOVED FROM THE PATIENT WITH THE SHAFT STRETCHED. THE BALLOON WAS NOTED TO BE BURST AND DISTORTED AND THE MARKERS WERE SEEN TO HAVE REMAINED IN THE PATIENT IN THE RIGHT ATRIUM. SNARING WAS ATTEMPTED BUT WAS UNSUCCESSFUL. A NON-ABBOTT HIGH PRESSURE BALLOON WAS INFLATED TO COMPLETE THE PROCEDURE, AND THE PATIENT WAS THEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20472504 ↗
• InjuryMar 26, 2024Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUBCLAVIAN VEIN WHERE THERE WAS A PREVIOUSLY IMPLANTED STENT, NO CALCIFICATION OR TORTUOSITY AND 50% STENOSIS. THE 10X80 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT ISSUE AND INFLATED; HOWEVER, AFTER THE FIRST INFLATION THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE, AND A PIECE OF THE BALLOON CAME OFF. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL AND MINIMAL FORCE WAS APPLIED. THE SEPARATED BALLOON MATERIAL WAS RETRIEVED VIA SNARE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979338 ↗
• MalfunctionMar 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ILIAC VEIN. POST DILATATION WAS TO BE PERFORMED WITH AN ARMADA 35 BALLOON. THE DEVICE WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND INFLATED ONCE AND RUPTURED BEFORE HITTING NOMINAL PRESSURE. ANOTHER ARMADA 35 BALLOON WAS THEN ADVANCED AND ALSO RUPTURED BEFORE HITTING NOMINAL PRESSURE. A THIRD BALLOON WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11562591 ↗
• InjuryMar 30, 2020Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance; Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: "PATIENT BROUGHT TO IR, ACCOMPANIED BY CRNA AND RN, FOR AN OUTPATIENT SCHEDULED FISTULOGRAM WITH POSSIBLE INTERVENTION. AN ANGIOPLASTY WAS ATTEMPTED. THE BALLOON USED BURST AND BECAME LODGED IN PATIENT. AFTER UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE BALLOON, THE PLAN WAS FOR THE PATIENT TO BE TAKEN TO OR TO HAVE BALLOON REMOVED SURGICALLY. PATIENT WAS REMOVED FROM PROCEDURE TABLE AND TAKEN TO POST OP. AFTER CONSULTING ADDITIONAL PHYSICIANS, THE DECISION WAS MADE TO BRING THE PATIENT BACK TO IR FOR A DIFFERENT APPROACH. THE PATIENT RETURNED TO IR ACCOMPANIED BY CRNA AND RN. AFTER CHANGING THE APPROACH THE FEMORAL ACCESS, THE BALLOON WAS RETRIEVED USING A SNARE. WHEN QUESTIONING STAFF, IT WAS NOTED THAT THERE WERE STENTS IN THE PATIENT THAT MIGHT HAVE SNAGGED THE BALLOON, HOWEVER IT IS UNCLEAR WHAT THE ROOT CAUSE WAS. UNFORTUNATELY, DUE TO THE CONDITION OF THE BALLOON, STAFF DISCARDED THE DEVICE POST-OP. THERE WAS NO HARM TO THE PATIENT, AND THEY WERE DISCHARGED SAME DAY." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897277 ↗
• MalfunctionFeb 26, 2020Burst Container or Vessel

  PATIENT BROUGHT TO IR, ACCOMPANIED BY CRNA AND RN, FOR AN OUTPATIENT SCHEDULED FISTULOGRAM WITH POSSIBLE INTERVENTION. AN ANGIOPLASTY WAS ATTEMPTED. THE BALLOON USED BURST AND BECAME LODGED IN PATIENT. AFTER UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE BALLOON, THE PLAN WAS FOR THE PATIENT TO BE TAKEN TO OPERATING ROOM TO HAVE BALLOON REMOVED SURGICALLY. PATIENT WAS REMOVED FROM PROCEDURE TABLE AND TAKEN TO POST OP. AFTER CONSULTING ADDITIONAL PHYSICIANS, THE DECISION WAS MADE TO BRING THE PATIENT BACK TO IR FOR A DIFFERENT APPROACH. THE PATIENT RETURNED TO IR ACCOMPANIED BY CRNA AND RN. AFTER CHANGING THE APPROACH TO FEMORAL ACCESS, THE BALLOON WAS RETRIEVED USING A SNARE. WHEN QUESTIONING STAFF, IT WAS NOTED THAT THERE WERE STENTS IN THE PATIENT THAT MIGHT HAVE SNAGGED THE BALLOON, HOWEVER IT IS UNCLEAR WHAT THE ROOT CAUSE WAS. UNFORTUNATELY, DUE TO THE CONDITION OF THE BALLOON, STAFF DISCARDED THE DEVICE POST-OP. THERE WAS NO HARM TO THE PATIENT, AND THEY WERE DISCHARGED SAME DAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752980 ↗
• MalfunctionMar 13, 2018Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED BASILIC VEIN. A 10 X 80MM ARMADA 35 BALLOON WAS INFLATED ONCE ABOVE THE RATED BURST PRESSURE AND RUPTURED. THE DEVICE WAS SIMPLY WITHDRAWN. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7335123 ↗