Armada A2040-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648156175), received between Oct 12, 2016 and Oct 17, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED DE NOVO LESION IN THE POPLITEAL ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 4X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED ON A COMMAND ES GUIDE WIRE AND THE BALLOON WAS INFLATED TO NOMINAL PRESSURE; HOWEVER, THE BALLOON WOULD ONLY PARTIALLY INFLATE. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND WHEN THE BDC WAS EXAMINED A LEAK AT THE HUB WAS NOTED. A 4X120MM ARMADA BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322592 ↗
• MalfunctionApr 17, 2025Difficult or Delayed Positioning; Improper or Incorrect Procedure or Method; Difficult or Delayed Positioning; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 4.0 X 200 MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED INTO THE ANATOMY; HOWEVER, BOTH THE DISTAL AND PROXIMAL MARKERS COULD NOT BE SEEN UNDER FLUOROSCOPY WHEN 70% CONTRAST WAS USED. THEREFORE, THE BDC WAS NOT USED AND THE DEVICE WAS REPLACED WITH A NON-ABBOTT DEVICE TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857199 ↗
• MalfunctionFeb 2, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AFTER CROSSING WITH A COMMAND ES GUIDE WIRE, A 4X200MM ARMADA 14 BALLOON WAS ADVANCED TO THE LESION TO PRE-DILATE. WHEN INFLATED AT NOMINAL PRESSURE, THE BALLOON DIDN'T OPEN UP COMPLETELY AND THEN A LEAKAGE AT THE HUB WAS NOTED. THE DEVICE WAS REMOVED. ANOTHER 4X120MM ARMADA 14 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 13424039 ↗
• InjuryDec 29, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT POSTERIOR TIBIAL VEIN. AN ARMADA 14 BALLOON WAS ADVANCED TO THE LESION WITHOUT ANY RESISTANCE AND INFLATED ONCE AT NOMINAL. DURING ATTEMPTED REMOVAL OF THE BALLOON, IT BECAME STUCK ON THE 6F INTRODUCER SHEATH AND THE DISTAL TIP SEPARATED. A SNARE DEVICE WAS USED TO RETRIEVE THE TIP FROM THE ANATOMY. IT WAS CONFIRMED THAT THE BALLOON WAS COMPLETELY DEFLATED BEFORE ATTEMPTED REMOVAL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13113756 ↗
• MalfunctionFeb 8, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN 80% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE POSTERIOR DESCENDING ARTERY. A 4.0X200MM ARMADA 14 BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE BALLOON CATHETER WAS BEING USED FOR PRE-DILATATION; HOWEVER, THE BALLOON ONLY PARTIALLY INFLATED AND A LEAK AT THE HUB WAS NOTED. THE BALLOON CATHETER WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 4.0X120MM ARMADA 14 BALLOON 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 11298494 ↗
• MalfunctionFeb 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVY CALCIFIED RIGHT ILLIAC ARTERY. THE 4.0X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION HOWEVER THE BALLOON RUPTURED AT 5-6 ATMOSPHERES (ATM). THE BALLOON WAS SUCCESSFULLY REMOVED AND REPLACED. 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 9717055 ↗
• MalfunctionJan 27, 2020Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE TIBIAL ARTERY. THE 4.0X200MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH NO ISSUE. DURING THE SECOND OR THIRD INFLATION TO 8 TO 14 ATMOSPHERES (ATM), THE BALLOON WOULD ONLY PARTIALLY DEFLATE. THE BDC WAS REMOVED PARTIALLY INFLATED WITH RESISTANCE NOTED. 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 9632929 ↗
• MalfunctionNov 28, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF A 4.0X200MM ARMADA 14 BALLOON DILATATION CATHETER, THE HUB WAS NOTED AS CRACKED. THE DEVICE WAS NOT USED. ANOTHER ARMADA 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. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A LEAK.

  Patient problems: No Patient Involvement

  MAUDE report 8111703 ↗
• MalfunctionDec 19, 2017Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED, RIGHT POSTERIOR TIBIA ARTERY, THE 4X200 MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION FOR ONE INFLATION AT 8 ATMOSPHERE (ATM), BUT RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE AND ANOTHER 4X200 MM ARMADA 14 BALLOON WAS ATTEMPTED TO BE INFLATED ONCE AT 8 ATM, BUT ALSO RUPTURED. THE DEVICE WAS REMOVED AND A 4X120 MM ARMADA 14 WAS SUCCESSFULLY USED IN THE PROCEDURE. 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 7130915 ↗
• MalfunctionDec 19, 2017Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED, RIGHT POSTERIOR TIBIA ARTERY, THE 4X200 MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION FOR ONE INFLATION AT 8 ATMOSPHERE (ATM), BUT RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE AND ANOTHER 4X200 MM ARMADA 14 BALLOON WAS ATTEMPTED TO BE INFLATED ONCE AT 8 ATM, BUT ALSO RUPTURED. THE DEVICE WAS REMOVED AND A 4X120 MM ARMADA 14 WAS SUCCESSFULLY USED IN THE PROCEDURE. 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 7130881 ↗
• MalfunctionNov 22, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT IN-STENT RESTENOSIS OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE ARMADA 14 BALLOON CATHETER WAS ADVANCED WITHOUT RESISTANCE AND INFLATED; HOWEVER, THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE DEVICE WAS REMOVED WITHOUT ISSUE AND REPLACED WITH ANOTHER OF THE SAME SIZE TO 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 7054070 ↗
• MalfunctionOct 19, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. THE ARMADA 14 4.0 X 200 MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER BALLOON RUPTURED IN THE PATIENT ANATOMY BELOW RATED BURST PRESSURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6962089 ↗
• MalfunctionFeb 14, 2017Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERIPHERAL ARTERY PROCEDURE. THE 3.0 X 60 MM ARMADA 14 AND THE 3.0 X 20 MM ARMADA 14 DILATATION CATHETERS WERE EACH ADVANCED TO THE TARGET LESION IN THE ANTERIOR TIBIAL ARTERY, WITHOUT DIFFICULTY. ATTEMPTS WERE MADE TO INFLATE THE BALLOONS; HOWEVER, FOR EACH DEVICE, THE BALLOON WOULD NOT INFLATE. THERE WAS NO ADVERSE PATIENT EFFECT. THE DEVICES WERE ABLE TO BE REMOVED FROM THE PATIENT ANATOMY WITHOUT DIFFICULTY AND THE TARGET LESION WAS TREATED WITH AN ADDITIONAL DEVICE. THE 4.0 X 20 MM ARMADA 14 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA); HOWEVER, DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED WITHOUT ISSUE AND THERE WAS NO ADVERSE PATIENT EFFECT. A SECOND DEVICE WAS USED SUCCESSFULLY TO COMPLETE DILATATION OF THE SFA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THE ABOVE MENTIONED DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6330970 ↗
• MalfunctionOct 12, 2016Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERIPHERAL PROCEDURE TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. THE 4.0 X 120 MM ARMADA 14 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, ON THE FIRST INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERES (ATM), POSSIBLY DUE TO THE VESSEL CALCIFICATION. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. THE 6.0 X 20 MM ARMADA 18 DILATATION CATHETER WAS THEN ADVANCED TO THE TARGET LESION. THIS DEVICE WAS INFLATED TO 10 ATM AND A RUPTURE OCCURRED AT 10 ATM, POSSIBLY DUE TO THE VESSEL CALCIFICATION. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. A NON-ABBOTT DILATATION CATHETER WAS USED. 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 6024579 ↗