Armada A2025-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648156038), received between Nov 20, 2018 and Jul 24, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 2.50X80 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED. ANOTHER ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17383636 ↗
• MalfunctionNov 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY, AND 75% STENOSIS. A COMMAND GUIDE WIRE WAS USED TO CROSS THE LESION AND THEN THE 2.5X80 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE CATHETER WAS POSITIONED ACROSS THE LESION AND INFLATED ONCE TO NOMINAL PRESSURE WHEN IT RUPTURED. ANOTHER ARMADA PTA CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762657 ↗
• MalfunctionFeb 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL, MODERATELY CALCIFIED LESIONS. AN ARMADA 35 BALLOON CATHETER ADVANCED TO THE SFA WITHOUT ISSUES. ON THE 1ST INFLATION AT 6 ATMOSPHERES (ATMS), THE BALLOON BURST. AN ARMADA 14 ADVANCED TO THE POPLITEAL WITHOUT ISSUES. ALSO, ON THE 1ST INFLATION AT 6 ATMS, THE BALLOON BURST. BOTH DEVICES WERE REMOVED WITHOUT ISSUE AND ANOTHER DEVICE WAS USED IN REPLACEMENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13431595 ↗
• MalfunctionJan 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 2.5X80MM ARMADA 14 DILATATION CATHETER WAS REMOVED FROM THE HOOP COIL WITHOUT ISSUE; HOWEVER, THE DEVICE COULD NOT BE PREPPED AS THE BALLOON LEAKED SALINE. IT WAS SUSPECTED THAT THERE WAS A PINHOLE IN THE BALLOON. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177134 ↗
• MalfunctionJan 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION. A 2.5 X 80 MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION. HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE BDC WAS THEN REMOVED AND REPLACED WITH AN UNSPECIFIED DEVICE. THE TARGET LESION WAS SUCCESSFULLY TREATED. 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 9582590 ↗
• MalfunctionJan 3, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT POSTERIOR TIBIAL ARTERY. THE 2.50X80MM ARMADA 14 BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION WITH NO RESISTANCE NOTED. DURING INFLATION, CONTRAST WAS SEEN LEAKING FROM THE BALLOON. THE DEVICE WAS WITHDRAWN WITH NO RESISTANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 9547833 ↗
• MalfunctionNov 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED PERIPHERAL ARTERY. A 2.5 X 80 MM ARMADA 14 BALLOON CATHETER WAS USED; HOWEVER, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER UNSPECIFIED ARMADA BALLOON CATHETER 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 8091069 ↗