Armada B2040-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648155086), received between Nov 30, 2016 and Mar 2, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF A 4X40 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), AIR CONTINUED TO ENTER THE INDEFLATOR DESPITE ATTEMPTS AT REMOVAL. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489857 ↗
• MalfunctionJan 27, 2026Material Rupture

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND 100% STENOSED SUPERFICIAL FEMORAL ARTERY. AN ARMADA 35 4MM/40MM WAS INSERTED AND ADVANCED TO THE TARGET LESION. HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6ATM. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED WITH A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193587 ↗
• MalfunctionJul 22, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 80% STENOSIS. THE 4X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED AND INFLATED; HOWEVER, IT WAS SEEN THE BALLOON ONLY PARTIALLY INFLATED AND THE DEVICE WAS LOSING PRESSURE. IT WAS NOTED THERE WAS A LEAK AT THE HUB OF THE DEVICE. THE BALLOON WAS REMOVED AND A NEW 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 22569032 ↗
• MalfunctionMar 11, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ILIAC ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 4X40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO ANATOMY. THEN THE BALLOON OF THE BDC WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574034 ↗
• MalfunctionDec 24, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION OF THE 4.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), A HOLE WAS NOTED IN THE SHAFT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18390005 ↗
• MalfunctionSep 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 4.0X40MM ARMADA BALLOON DILATATION CATHETER (BDC) A LEAK WAS NOTED AT THE DISTAL END OF THE SHAFT, WHERE THE BALLOON IS ATTACHED. THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER SAME SIZE ARMADA WAS USED THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781777 ↗
• MalfunctionMay 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED DE NOVO SUPERIOR FEMORAL ARTERY (SFA). A 4.0X40MM ARMADA 35 WAS ATTEMPTED TO DILATE THE LESION BUT RUPTURED AT FIRST INFLATION REACHING 16 ATMOSPHERES (ATM). ANOTHER DIFFERENT SIZE ARMADA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10092210 ↗
• MalfunctionDec 10, 2017Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH NO TORTUOSITY AND NO CALCIFICATION IN THE MID SUPERFICIAL FEMORAL ARTERY. THE 4.0 X 40 MM ARMADA 35 BALLOON CATHETER WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION, BUT DURING INFLATION THE BALLOON RUPTURED. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7102661 ↗
• MalfunctionNov 30, 2016Inflation Problem; Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH MILD TORTUOSITY, MILD CALCIFICATION AND 99% STENOSIS IN A SHUNT. THE PROTECTIVE SHEATH WAS REMOVED FROM THE 4.0 X 40 MM ARMADA 35 BALLOON WITHOUT RESISTANCE. THE ARMADA 35 BALLOON CATHETER WAS ADVANCED WITHOUT RESISTANCE TO DILATE THE LESION, BUT WHEN ATTEMPTING TO INFLATE THE BALLOON, PRESSURE WOULD NOT INCREASE. THE ARMADA 35 WAS WITHDRAWN FROM THE PATIENT ANATOMY TO EXAMINE AND A LEAK WAS NOTED FROM THE TIP AND DISTAL PART OF THE BALLOON. A NEW ARMADA 35 BALLOON WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6137145 ↗