Armada B1140-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648155031), received between Jul 6, 2018 and Nov 11, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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.

• InjuryNov 11, 2023Off-Label Use; Difficult to Remove; Material Rupture; Material Separation; Off-Label Use; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ILIAC VEIN. THE 14X60 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED THREE TIMES TO 11 ATMOSPHERES BUT THE BALLOON RUPTURED. THE DEVICE WAS FULLY DEFLATED UPON REMOVAL; HOWEVER, THE DEVICE BECAME STUCK ON THE END OF THE INTRODUCER SHEATH IN THE RIGHT INTERNAL JUGULAR VEIN DURING REMOVAL. A KNIFE WAS USED TO CUT THE FLUSH PORT OF THE DEVICE AND THEN THE ACCESS SHEATH WAS REMOVED. A LARGER SHEATH WAS THEN ATTEMPTED AND THE DISTAL MARKER OF THE BALLOON WAS ABLE TO BE CAPTURED. WHEN THE DEVICE WAS RETRIEVED, IT WAS INSPECTED AND IT WAS FOUND THAT SOME OF THE BALLOON MATERIAL HAD SEPARATED, ABOUT 1-5 MM OF MATERIAL. AN ANGIOGRAM WAS PERFORMED AND A CAVA-GRAM. INTRAVASCULAR ULTRASOUND (IVUS) WAS ALSO PERFORMED AND A FOCUSED SCAN OF THE NECK, AND NO DEBRIS OR FOREIGN BODY WAS SEEN; HOWEVER, A SMALL FRAGMENT LIKELY REMAINS IN THE PATIENT. A BEDSIDE ECHOCARDIOGRAM WAS PERFORMED AS THERE WAS SINUS TACHYCARDIA WHICH OCCURRED RELATED TO GUIDE WIRE AND CATHETER MANIPULATION. THE PATIENT WAS HELD FOR OBSERVATION BUT THEY ARE WELL AND ASYMPTOMATIC. SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THAT TH

  Patient problems: Foreign Body In Patient; Tachycardia

  MAUDE report 18117103 ↗
• MalfunctionSep 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT TARGET LESIONS IN THE RIGHT AND LEFT ILIAC VEINS. THE FIRST ARMADA DILATATION CATHETER WAS ADVANCED INTO THE RIGHT ILIAC VEIN WITHOUT DIFFICULTY AND INFLATED THREE TIMES. ON THE THIRD INFLATION, THE BALLOON WAS INFLATED TO 4 ATMOSPHERES (ATM) AND RUPTURED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND THERE WAS NO ADVERSE PATIENT EFFECT. DILATATION WAS COMPLETED USING A 16 X 60 MM NON-ABBOTT DILATATION CATHETER. THE SECOND ARMADA DILATATION CATHETER WAS ADVANCED INTO THE LEFT ILIAC VEIN WITHOUT DIFFICULTY AND INFLATED ONE TIME, TO 2 ATM; HOWEVER, A BALLOON RUPTURE OCCURRED. THERE WAS NO DIFFICULTY REMOVING THE DEVICE AND NO ADVERSE PATIENT EFFECT. DILATATION WAS COMPLETED USING THE 16 X 60 MM NON-ABBOTT DILATATION CATHETER. 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 12544641 ↗
• MalfunctionSep 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT TARGET LESIONS IN THE RIGHT AND LEFT ILIAC VEINS. THE FIRST ARMADA DILATATION CATHETER WAS ADVANCED INTO THE RIGHT ILIAC VEIN WITHOUT DIFFICULTY AND INFLATED THREE TIMES. ON THE THIRD INFLATION, THE BALLOON WAS INFLATED TO 4 ATMOSPHERES (ATM) AND RUPTURED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND THERE WAS NO ADVERSE PATIENT EFFECT. DILATATION WAS COMPLETED USING A 16 X 60 MM NON-ABBOTT DILATATION CATHETER. THE SECOND ARMADA DILATATION CATHETER WAS ADVANCED INTO THE LEFT ILIAC VEIN WITHOUT DIFFICULTY AND INFLATED ONE TIME, TO 2 ATM; HOWEVER, A BALLOON RUPTURE OCCURRED. THERE WAS NO DIFFICULTY REMOVING THE DEVICE AND NO ADVERSE PATIENT EFFECT. DILATATION WAS COMPLETED USING THE 16 X 60 MM NON-ABBOTT DILATATION CATHETER. 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 12544640 ↗
• MalfunctionSep 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A LESION IN THE LEFT COMMON ILIAC VEIN. AN ARMADA 35 14MM/60MM WAS INSERTED, BUT DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 4 ATMOSPHERES. THE DEVICE WAS REMOVED AND REPLACED WITH THE SAME SIDE ARMADA 35. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12492347 ↗
• MalfunctionFeb 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT COMMON ILIAC VEIN. A NON-ABBOTT STENT WAS IMPLANTED. THEN ONE 14 X 60 MM ARMADA 35 AND ONE 14 X 40 MM ARMADA 35 BALLOON DILATATION CATHETERS (BDC) WERE ADVANCED SIMULTANEOUSLY THROUGH TWO DIFFERENT ACCESS SITES FOR POST-DILATATION. HOWEVER, BOTH BALLOONS RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION. BOTH ARMADA BDC DEVICES WERE SIMPLY REMOVED. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT IS STABLE. 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 9664277 ↗
• MalfunctionJul 6, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO POST-DILATE A PREVIOUSLY IMPLANTED UNSPECIFIED STENT IN AN UNSPECIFIED VEIN WITH A 14 X 60 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. THE PTA CATHETER WAS ADVANCED TO THE STENT, BUT WHEN INFLATED, THE BALLOON RUPTURED. 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 7667796 ↗