Armada 1013468-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648208201), received between Mar 30, 2017 and Mar 2, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Deflation Problem; Failure to Fold; Difficult to Advance

  IT WAS REPORTED THAT THE VESSEL TO BE TREATED WAS THE RIGHT POPLITEAL ARTERY. THE 300 CM HT COMMAND ES GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED THROUGH THE BALLOON DILATATION CATHETER PORT BUT WAS UNSUCCESSFUL AND THE TIP OF THE GUIDE WIRE KINKED. A NEW COMMAND GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE. THE ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED ONCE TO 8 ATMOSPHERES BUT ONLY PARTIALLY DEFLATED. ULTIMATELY THE BALLOON WAS DEFLATED. AN ATTEMPT WAS MADE TO USE THE BDC FOR POST-DILATATION, BUT DIFFICULTY WAS NOTED ADVANCING THE BALLOON THROUGH THE INTRODUCER SHEATH. A NEW ARMADA BDC 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 24491707 ↗
• InjuryMay 15, 2024Entrapment of Device; Leak/Splash; Entrapment of Device; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 100% STENOSED LESION IN LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. FOR POST DILATATION A 5X200MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS USED; HOWEVER, THE BALLOON RUPTURED AFTER 3 INFLATIONS AT 8 ATMOSPHERES. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. ANOTHER SAME SIZE ARMADA 18 BDC WAS THEN USED TO CONTINUE POST DILATION; HOWEVER, DURING THE FIRST INFLATION THE SECOND ARMADA BALLOON WAS NOTED TO HAVE A LEAK OF CONTRAST AT THE BASE OF THE INFLATION PORT. DURING REMOVAL, THE SECOND BDC BECAME STUCK WITH THE STENT THAT HAD BEEN IMPLANTED AND COULD NOT BE REMOVED FROM THE PATIENT. THEREFORE, CUT-DOWN SURGERY WAS PERFORMED TO REMOVE THE BDC. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325958 ↗
• InjuryAug 1, 2022Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION AND 85% STENOSIS. THE ARMADA 18 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM). DURING REMOVAL OF THE BALLOON CATHETER, THE DISTAL PORTION OF THE BALLOON SEPARATED. THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE BALLOON CATHETER. A SNARE DEVICE WAS ABLE TO RETRIEVE THE SEPARATED PORTION OF THE BALLOON TO THE ILIAC AND THERE AN OMNILINK STENT WAS USED TO COMPRESS THE BALLOON AGAINST THE VESSEL TO SECURE THE SEPARATED PORTION FROM FREE FLOATING IN THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15142512 ↗
• MalfunctionOct 13, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 5.0 X 100MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION, DURING THE SECOND INFLATION THE BALLOON RUPTURED AT 12 ATMOSPHERES. ANOTHER ARMADA 18 BALLOON 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 12624180 ↗
• MalfunctionJan 26, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 5.0X100MM ARMADA 18 BALLOON CATHETER, BUBBLES WERE OBSERVED ON ASPIRATION. THERE WAS NO PATIENT INVOLVEMENT. A NEW ARMADA 18 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 11232690 ↗
• MalfunctionApr 17, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL. THE 5.0X100MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE; HOWEVER, THE DEVICE WAS PRESSURIZED AND WOULD NOT REACH NOMINAL INFLATION. THE DEVICE WOULD NOT HOLD PRESSURE AND THE BALLOON PARTIALLY INFLATED, AND IT WAS NOTED THAT THERE WAS A LEAK AT THE HUB. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE, AND AN ARMADA 35 PTA CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS, AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8523456 ↗
• MalfunctionMar 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA), THREE DIFFERENT ARMADA 18 BALLOON DILATATION CATHETERS (BDC) WERE USED; EACH RUPTURED DURING THE FIRST INFLATION AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT BDC WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394590 ↗
• MalfunctionOct 16, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION. A 5.0 X 100 MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE SFA. DURING THE FIRST INFLATION, THE BALLOON WAS INFLATED TO 10 ATMOSPHERES WHEN IT COULD NOT HOLD PRESSURE. A LEAK IN THE DISTAL PORTION OF THE STRAIN RELIEF WAS OBSERVED. THE BDC WAS REMOVED AND REPLACED WITH AN UNSPECIFIED BALLOON CATHETER 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 Consequences Or Impact To Patient

  MAUDE report 7969515 ↗
• MalfunctionMar 14, 2018Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 5.0 X 100 MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS USED; HOWEVER, IT MET RESISTANCE WITH A 4.0 X 300 CM STEELCORE GUIDE WIRE WHEN THE BDC WAS ADVANCING OVER THE GUIDE WIRE. POSITIONING WAS LOST; THEREFORE, BOTH DEVICES WERE REMOVED AS A SINGLE UNIT AND ANOTHER UNSPECIFIED BDC AND A GUIDE WIRE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS RESISTANCE BETWEEN THE ARMADA BDC AND THE GUIDE WIRE DURING REMOVAL. THERE WAS A DELAY IN THE PROCEDURE BUT IT WAS NOT CLINICALLY SIGNIFICANT, AND THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7340072 ↗
• MalfunctionNov 27, 2017Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT POPLITEAL ARTERY. A 5.0 X 100MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION. THE BDC WAS INFLATED ONCE AT 14 ATMOSPHERES AND IT WAS NOTED THERE WAS A LEAK AT THE HUB. THE PHYSICIAN CONTINUED TO ATTEMPT TO PRESSURIZE THE BALLOON (WHICH WAS INFLATED) BUT IT WOULD NOT HOLD THE PRESSURE. ANOTHER ARMADA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7061262 ↗
• MalfunctionNov 7, 2017Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MODERATE CALCIFICATION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 5.0 X 100 MM ARMADA 18 BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE, BUT THE BALLOON RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. ANOTHER ARMADA 18 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 Consequences Or Impact To Patient

  MAUDE report 7008248 ↗
• MalfunctionMay 1, 2017Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED POPLITEAL ARTERY. A 5.0X 100 MM ARMADA 18 BALLOON CATHETER WAS ADVANCED TO THE LESION; HOWEVER, WHEN ATTEMPTING TO INFLATE THE BALLOON THERE WAS A LEAK AT THE STRAIN RELIEF TUBING. ANOTHER ARMADA 18 WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6533953 ↗
• MalfunctionMar 30, 2017Leak/Splash

  IT WAS REPORTED THAT AIR ASPIRATION WAS BEING PERFORMED ON THE ARMADA 18 DILATATION CATHETER PRIOR TO USE AND AIR KEPT BEING ASPIRATED OUT AS IF THERE WAS A HOLE IN THE DEVICE. THIS WAS PERFORMED FOUR TIMES WITH THE SAME RESULT. THIS DEVICE WAS NOT USED ON THE PATIENT. ANOTHER ARMADA 18 WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6446986 ↗