Armada B1140-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648155048), received between May 23, 2018 and Dec 5, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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.

• MalfunctionDec 5, 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 STENOSED RIGHT FISTULA IN THE SUB-CLAVIAN. THE 14X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES. DURING REMOVAL RESISTANCE WAS NOTED WITH ANATOMY AND ONCE IN THE SHEATH THE DEVICE SEPARATED AT THE SHAFT, BUT WAS REMOVED ALL TOGETHER WITH THE SHEATH. A HIGH PRESSURE BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915725 ↗
• 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 11562533 ↗
• MalfunctionJul 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN UNSPECIFIED LESION. THE 14X80MM ARMADA 35 BALLOON RUPTURED AT AN UNSPECIFIED PRESSURE WHILE ATTEMPTING TO POST DILATE A NON-ABBOTT STENT. THE SAME OCCURRED WITH A NEW 14X80MM ARMADA 35 BALLOON. IN THE PHYSICIAN¿S OPINION, THE BALLOONS RUPTURED DUE TO THE JAGGEDNESS OF THE NON-ABBOTT STENT. THERE WERE NO REPORTED 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 10314207 ↗
• MalfunctionJul 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN UNSPECIFIED LESION. THE 14X80MM ARMADA 35 BALLOON RUPTURED AT AN UNSPECIFIED PRESSURE WHILE ATTEMPTING TO POST DILATE A NON-ABBOTT STENT. THE SAME OCCURRED WITH A NEW 14X80MM ARMADA 35 BALLOON. IN THE PHYSICIAN¿S OPINION, THE BALLOONS RUPTURED DUE TO THE JAGGEDNESS OF THE NON-ABBOTT STENT. THERE WERE NO REPORTED 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 10314187 ↗
• MalfunctionSep 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE ARMADA DILATATION CATHETER ADVANCED TO AN UNSPECIFIED LESION WITHOUT NOTED ISSUE. BALLOON INFLATION WAS PERFORMED TO 8 ATMOSPHERES WHEN THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS AVAILABLE REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7847199 ↗
• MalfunctionMay 23, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO POST DILATE A STENT IN AN UN-CALCIFIED, NON-TORTUOUS, ILIAC VEIN WITH THE 4.0X80 MM ARMADA 35 BALLOON. THE ARMADA WAS ADVANCED TO THE VESSEL AND INFLATED TO 4 ATMOSPHERES WHEN IT RUPTURED. THE ARMADA WAS REMOVED FROM THE ANATOMY AND REPLACED WITH A NON-ABBOTT BALLOON. 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 7539423 ↗