Armada B2080-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648155451), received between Dec 3, 2019 and Sep 25, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS RIGHT COMMON ILIAC ARTERY. THE 8.0X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED BEFORE NOMINAL PRESSURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17812812 ↗
• InjuryJan 20, 2022Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT FEMORAL ARTERIOVENOUS (AV) GRAFT. AN 8X80MM ARMADA 35 AND 7X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WERE BEING USED IN THE PROCEDURE AND ADVANCED SEPARATELY TO THE AV GRAFT. BOTH BALLOONS WERE INFLATED TWO TO THREE TIMES EACH, TO 13 ATMOSPHERES (ATM) WHEN THE BALLOONS RUPTURED. IN AN ATTEMPT TO PULL THE BALLOONS BACK INTO THE SHEATH FOR REMOVAL, A SEPARATION OCCURRED. SOME OF THE BALLOON PIECES WERE REMOVED FROM THE ANATOMY WITH ENDOSCOPIC FORCEPS. THE PATIENT¿S ENTIRE ANATOMY WAS X-RAYED TO TRY TO FIND THE REMAINING BROKEN PORTION OF THE BALLOON, BUT IT WAS UNABLE TO BE FOUND. THE PATIENT CAME BACK TO THE OPERATING ROOM ON THE (B)(6) 2021; HOWEVER, THE OUTCOME FROM THAT PROCEDURE IS UNKNOWN. IT WAS NOTED THAT ¿IT IS LESS LIKELY THAT THE BALLOONS RUPTURED, BUT INSTEAD WERE SNAGGED ON STENTS THAT WERE ALREADY IN PLACE IN THE PATIENT¿S LEG¿. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311603 ↗
• MalfunctionOct 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION IN THE RIGHT COMMON ILIAC ARTERY. AN 8 X 80 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS ADVANCED TO PERFORM DILATATION; HOWEVER, THE BALLOON RUPTURED DURING FIRST INFLATION AT 8 ATMOSPHERES. ANOTHER ARMADA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10673303 ↗
• MalfunctionDec 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE VARICOSIS OF GREAT SAPHENOUS VEIN. DURING THE PROCEDURE, AN 8X80MM ARMADA 35 BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES AND THE PATIENT FELT SEVERE PAIN. THE DEVICE WAS IMMEDIATELY REPLACED WITH AN UNSPECIFIED ONE AND THE PATIENT WAS GIVEN MEDICATIONS AS SYMPTOMATIC TREATMENT. THE PATIENT'S RESPIRATION, HEARTBEAT, AND BLOOD PRESSURE REMAINED STABLE DURING THE ENTIRE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 9404895 ↗