Armada 1013465-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648207891), received between May 18, 2018 and Apr 12, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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.

• MalfunctionApr 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT SUPERIOR FEMORAL ARTERY (SFA). A 3.0X100X150CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND INFLATED ONE TIME TO 6 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED. A NEW ARMADA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728526 ↗
• MalfunctionAug 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR TIBIAL ARTERY THAT WAS HEAVILY CALCIFIED. THE ARMADA BALLOON WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER, ON THE SECOND INFLATION TO 12 ATMOSPHERES (ATM), THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER ARMADA WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298812 ↗
• MalfunctionMar 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND A LESION IN THE MILDLY CALCIFIED ANTERIOR TIBIAL ARTERY. THE 6.0MM X 120MM X 150CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION IN THE LEFT SFA. DURING THE FIRST INFLATION, TO 13 ATMOSPHERES, THE BALLOON RUPTURED. A SAME SIZE ARMADA 18 WAS USED WITHOUT ISSUE. A 3.0MM X 100MM X 150CM ARMADA 18 BDC WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION IN THE ANTERIOR TIBIAL ARTERY. DURING THE FIRST INFLATION, TO 13 ATMOSPHERES, THE BALLOON RUPTURED. A SAME SIZE ARMADA 18 WAS USED WITHOUT ISSUE. 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 13940609 ↗
• MalfunctionOct 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LEFT PERONEAL ARTERY WITH HEAVY CALCIFICATION. A NON-ABBOTT GUIDE WIRE (GW) WAS ADVANCED TO THE TARGET LESION. THEN A 3.0 X100MM OTW ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER THE GW AND TO THE TARGET LESION WITHOUT ISSUE. DURING FIRST INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERES. THE BDC WAS REMOVED AND A 3.0 X100MM OTW ARMADA BDC 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 12698428 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH ISCHEMIC REST PAIN OF THE RIGHT FOOT. PER IMAGING, A COMPLEX CHRONIC TOTAL OCCLUSION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL RIGHT POPLITEAL ARTERY. THE CALCIFICATION WAS SEVERE AND ECCENTRIC. SFA AND POPLITEAL BALLOON ANGIOPLASTY WAS PERFORMED USING AN ARMADA18 (3.0MMX100MMX150CM-OTW), AND NON-ABBOTT BALLOON CATHETERS. FOLLOWING, THERE WAS SIGNIFICANT RECOIL DUE TO THE SEVERE CALCIFICATION. AS TREATMENT, ADDITIONAL BALLOON DILATATION WAS PERFORMED AND THE RECOIL REMAINED. A 3.5X38MM PROMUS STENT WAS SUBSEQUENTLY IMPLANTED. POST STENT IMPLANTATION, AN ARTERIAL-VENOUS (AV) FISTULA WAS NOTED BETWEEN THE ANTERIOR TIBIAL (AT) ARTERY AND AT VEIN. AS TREATMENT FOR THE AV FISTULA, BALLOON ANGIOPLASTY WAS PERFORMED WITHOUT RESOLVE. A 3.5X16MM GRAFTMASTER (GM) STENT WAS IMPLANTED IN THE DISTAL, STENTED PORTION. REPORTEDLY, THE GM STENT SEALED AT THE IMPLANTATION SITE AND PERFORMED AS INTENDED. THERE WAS A SIGNIFICANT REDUCTION IN THE AV FISTULA AND PROLONGED BALLOON INFLATION WAS PERFORMED IN THE PROXIMAL PORTION. REPEAT IMAGING WAS PERFORMED DISPLAYING A PATENT RIGHT SFA AND POPLITEAL ARTERY GOING INTO THE A

  Patient problems: Vasoconstriction

  MAUDE report 9140371 ↗
• MalfunctionJul 10, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE NON-TORTUOUS, NON-CALCIFIED, 95% STENOSED, MID, LEFT, SUPERFICIAL FEMORAL ARTERY (SFA) WITH A 3.00 X 100 MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. THE PTA CATHETER WAS ADVANCED TO THE LESION AND INFLATED. WHILE THE BALLOON WAS INFLATED, CONTRAST WAS SEEN LEAKING FROM THE STRAIN RELIEF AT THE HUB. AS THEY WERE ABLE TO SUFFICIENTLY DILATE THE LESION AND COMPLETE THE PROCEDURE, A REPLACEMENT PTA CATHETER WAS NOT NEEDED. 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 7675372 ↗
• MalfunctionMay 18, 2018Device Difficult to Setup or Prepare; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. THE 3.0X100MMX150CM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION AND WAS USED WITHOUT ISSUE. THE ARMADA BDC WAS REMOVED WITHOUT ISSUE, HOWEVER WHEN AN ATTEMPT WAS MADE TO FLUSH THE BDC TO REUSE IT AGAIN, THE ARMADA BDC COULD NOT BE FLUSHED. ANOTHER BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED FLUID WAS OBSERVED COMING OUT FROM A PINHOLE IN THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7527072 ↗