Armada B2040-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648155123), received between Nov 18, 2016 and Apr 24, 2025 — classified as 5 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT TO A MODERATELY CALCIFIED, MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. AFTER CROSSING AN UNSPECIFIED .035 GUIDEWIRE A 4.0X120MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED AND CROSSED THE LESION. WHEN ATTEMPTING TO INFLATE THE BALLOON TO NOMINAL PRESSURE THE BALLOON DID NOT INFLATE TO ITS COMPLETE PROFILE. A LEAK WAS OBSERVED AT THE HUB. THE BALLOON WAS REMOVED AND A 4.0X80MM ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS 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 21901460 ↗
• MalfunctionMar 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 50% STENOSED LESION IN THE POPLITEAL ARTERY. A 4X120MM ARMADA 35 BALLOON CATHETER WAS PREPARED PER THE IFU AND ADVANCED TO THE LESION. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES (ATM) WITHOUT ISSUE BUT UPON FURTHER INFLATION, A PRESSURE LOSS WAS NOTED, AND CONTRAST WAS COMING OUT OF THE GUIDE WIRE (GW) PORT. THE ARMADA BALLOON WOULD NOT INFLATE MORE THAN 8 ATM. THE DEVICE WAS REMOVED, AND A NON-ABBOTT BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11544182 ↗
• MalfunctionNov 14, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 4.0 X 120 MM ARMADA 35 DILATATION CATHETER INFLATED ONE TIME, TO NOMINAL PRESSURE. A LEAK WAS NOTED DURING INFLATION; HOWEVER, THE BALLOON DID NOT RUPTURE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND REPLACED WITH A SECOND DEVICE. NO ISSUES WERE NOTED WITH THE SECOND DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9325170 ↗
• MalfunctionSep 6, 2019Leak/Splash; Material Rupture; Improper or Incorrect Procedure or Method; Leak/Splash; Material Rupture; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION: DEVICE ANALYSIS DID NOT CONFIRM THE LEAK FROM THE HUB AND NOTED LEAKAGE FROM THE BALLOON. IT WAS CONFIRMED FROM THE ACCOUNT THAT THE RUPTURE OCCURRED DURING THE PROCEDURE. THE BALLOON RUPTURED AT 3ATMS ON THE FIRST INFLATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8970098 ↗
• MalfunctionNov 18, 2016Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 4.0 X 120 MM ARMADA 35 WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERE (ATM) AT THE FIRST INFLATION. THE DEVICE WAS WITHDRAWN WITHOUT ANY ISSUES NOTED FROM THE PATIENT ANATOMY. A 6.0 X 60 MM ARMADA 35 WAS ADVANCED SUCCESSFULLY WITHOUT ANY ISSUES TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED AT 8 ATM AT THE FIRST INFLATION AS WELL. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 6114552 ↗