Armada 1013464-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648207808), received between Jan 16, 2017 and Apr 1, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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.

• MalfunctionApr 1, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. THE 2.5MM X 100MM X 150CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION. HOWEVER, PRIOR TO INFLATION, WHEN PULLING NEGATIVE, BUBBLES WERE OBSERVED COMING FROM THE PROXIMAL EDGE OF THE BALLOON. THE BDC WAS REMOVED, AND A NEW SAME SIZE ARMADA 18 WAS USED 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978285 ↗
• MalfunctionApr 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN 80% STENOSED AND MILDLY CALCIFIED LESION IN THE POSTERIOR TIBIAL ARTERY. A 2.5X100MM ARMADA 18 BALLOON RUPTURED AT NOMINAL PRESSURE DURING THE FIRST INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. 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 11624976 ↗
• MalfunctionJan 31, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF A 2.5X100MM ARMADA 18 BALLOON DILATATION CATHETER, IT WAS NOTED THAT THE DEVICE DID NOT HOLD PRESSURE AND LEAKED AIR. TWO DIFFERENT STOPCOCKS AND SYRINGES WERE USED TO MAKE SURE THE LEAK WAS COMING FROM THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER ARMADA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Patient Involvement

  MAUDE report 8294923 ↗
• MalfunctionApr 5, 2018Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6.0/40 MM ARMADA 18 BALLOON CATHETER, SALINE WAS OBSERVED LEAKING FROM THE HUB OF THE DEVICE. THE DEVICE WAS NOT USED ON THE PATIENT. A NEW ARMADA 18 BALLOON CATHETER WAS USED SUCCESSFULLY FOR THE CASE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7401217 ↗
• MalfunctionMay 9, 2017Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE 6.0 MM X 40 MM 150 CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED IN THE PATIENT ANATOMY WITHOUT RESISTANCE. HOWEVER, DURING THE FIRST INFLATION TO 8 ATMOSPHERES THE BALLOON RUPTURED. THE BDC WAS REMOVED AND WAS REPLACED WITH AN UNSPECIFIED ARMADA BDC 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: No Consequences Or Impact To Patient

  MAUDE report 6555849 ↗
• MalfunctionJan 16, 2017Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH HEAVY CALCIFICATION IN THE LEFT ANTERIOR TIBIAL ARTERY. THE 2.5X100 MM ARMADA 18 BALLOON CATHETER WAS PREPARED ACCORDINGLY TO THE INSTRUCTION FOR USE (IFU) AND ADVANCED WITH NO RESISTANCE NOTED TO THE TARGET LESION. DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 20 ATMOSPHERE (ATM). THE COMPLETE DEVICE WAS WITHDRAWN FROM THE PATIENTS ANATOMY WITHOUT ANY COMPLICATIONS. A 2.5X150 MM ARMADA 18 BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6255007 ↗