Armada A2030-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08717648156076), received between Jan 26, 2017 and Dec 5, 2025 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT TIBIOPERONEAL TRUNK. THE 3.0X40MM ARMADA 14 PERIPHERAL DILATATION BALLOON CATHETER WAS INFLATED TO 12 ATMOSPHERES DURING THE INFLATION; HOWEVER, RUPTURED. AN UNSPECIFIED ESPRIT BELOW THE KNEE WAS IMPLANTED AND A 4X40MM UNSPECIFIED ARMADA BALLOON WAS USED TO POST DILATATE. THERE WAS 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 23727592 ↗
• MalfunctionDec 2, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT WHEN THE OUTER PACKAGING OF THE 3X40 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS OPENED, IT WAS FOUND THAT THE INNER SEAL WAS ALREADY OPENED. THEREFORE, THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695154 ↗
• MalfunctionNov 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 3.0X40 MM ARMADA BALLOON WAS SOAKED PRIOR TO USE AND PREPARED OUTSIDE THE ANATOMY WITHOUT ISSUES. IT WAS ADVANCED TO THE HIGHLY CALCIFIED, LEFT SUPERFICIAL FEMORAL ARTERY (L SFA) WITHOUT RESISTANCE. IT WAS INFLATED ONE TIME TO 8 ATMOSPHERES AND RUPTURED DURING TREATMENT OF A RESTENOSED STENT IN THE L SFA. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23573912 ↗
• MalfunctionNov 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED ANTERIOR TIBIAL ARTERY. THE 3.0X40MM ARMADA 14 BALLOON DILATATION CATHETER RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. A NEW ARMADA 14 WAS USED TO SUCCESSFULLY 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23547594 ↗
• InjuryOct 28, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POPLITEAL ARTERY WITH HEAVY CALCIFICATION. THE 3.0X40 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS USED AND DEFLATED; HOWEVER, DURING REMOVAL THERE WAS SLIGHT RESISTANCE WITH THE ANATOMY AND THE TIP OF THE DEVICE SEPARATED AT THE WELD. A SNARE WAS USED TO RETRIEVE THE SEPARATED PIECES. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547029 ↗
• MalfunctionApr 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PERONEAL ARTERY THAT WAS MODERATELY CALCIFIED. REPORTEDLY, THE ARMADA 14 BALLOON WOULD NOT STAY INFLATED; AIR WAS LEAKING FROM THE HUB WHERE IT CONNECTS TO THE CATHETER. ANOTHER ARMADA 14 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 16770247 ↗
• MalfunctionMar 8, 2023Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY. A NON-ABBOTT RUN-THROUGH GUIDE WIRE (GW) WAS IN THE TARGET LESION AND A 3.0X40MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED TO THE SHEATH, BUT COULD NOT ADVANCE DUE TO BLOOD AND CONTRAST ON THE GUIDE WIRE. AN ATTEMPT WAS MADE TO REMOVE THE BDC FROM THE GUIDE WIRE, BUT IT COULD NOT BE REMOVED. FORCE WAS USED AND THEY WERE ABLE TO PULL THE BDC OFF OF THE GUIDE WIRE RESULTING IN THE TIP OF THE BDC SEPARATING OUTSIDE OF THE ANATOMY. THE GUIDE WIRE WAS WIPED DOWN AND A NEW ARMADA 14 WAS USED WITHOUT ISSUE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16507000 ↗
• MalfunctionFeb 28, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE ARTERIOVENOUS (AV) FISTULA. THE ARMADA 14 BALLOON WAS INFLATED IN THE AV FISTULA. IT WAS THEN NOTED THAT THE BALLOON WAS BARELY INFLATING AND A SLOW LEAK AT THE DISTAL END OR TIP OF THE ARMADA WAS NOTED ON ANGIOGRAM. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457188 ↗
• MalfunctionApr 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. THE 3.0 X 40 MM ARMADA 14 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION. ON THE FIRST INFLATION, THE DILATATION CATHETER BALLOON RUPTURED AT 4 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14177677 ↗
• MalfunctionOct 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A LOWER LEG INTERVENTION, THE ARMADA 14 BALLOON RUPTURED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER ARMADA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION REGARDING THIS ISSUE WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10623017 ↗
• MalfunctionJun 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, NON-TORTUOUS, 70% STENOSED SUPERFICIAL FEMORAL ARTERY. A 6X200MM, 3X80MM, & 5.5X200MM ARMADA 18 AS WELL AS A 3X40MM & 4X60MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETERS (PTA) WERE ALL ADVANCED, AND THE BALLOONS RUPTURED AT 14 ATMOSPHERES IN THAT ORDER. A NON-ABBOTT BALLOON AND TWO UNSPECIFIED STENTS WERE 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 Consequences Or Impact To Patient

  MAUDE report 10154033 ↗
• MalfunctionOct 11, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. THE ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT ISSUE AND COULD NOT HOLD PRESSURE. A LEAK WAS NOTED AT THE HUB. THE CATHETER WAS DEFLATED AND REMOVED WITHOUT ISSUE AND A NEW, NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9180574 ↗
• MalfunctionJun 28, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY CALCIFIED TIBIAL TRUNK. THE 3.0MMX40MMX150CM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WOULD NOT ADVANCE OVER THE GUIDE WIRE TO GET TO THE LESION. DUE TO THIS RESISTANCE, THE BDC WAS ATTEMPTED TO BE REMOVED FROM GUIDE WIRE; HOWEVER, THE BDC COULD NOT BE REMOVED FROM THE GUIDE WIRE. BOTH DEVICES WERE REMOVED TOGETHER. A NEW GUIDE WIRE AND BDC WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746070 ↗
• MalfunctionApr 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TREATING AN ANTERIOR TIBIAL VESSEL WITH EXTREMELY HEAVY, JAGGED CALCIFICATION. FOUR UNSPECIFIED BALLOON CATHETERS HAD FAILED TO DILATE THE LESION. FOLLOWING, TWO ARMADA BALLOON DILATATION CATHETERS WERE ALSO ATTEMPTED. BOTH WERE INFLATED ABOVE RATED BURST PRESSURE AND BOTH BALLOONS BURST. ANOTHER ARMADA WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8505697 ↗
• MalfunctionApr 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TREATING AN ANTERIOR TIBIAL VESSEL WITH EXTREMELY HEAVY, JAGGED CALCIFICATION. FOUR UNSPECIFIED BALLOON CATHETERS HAD FAILED TO DILATE THE LESION. FOLLOWING, TWO ARMADA BALLOON DILATATION CATHETERS WERE ALSO ATTEMPTED. BOTH WERE INFLATED ABOVE RATED BURST PRESSURE AND BOTH BALLOONS BURST. ANOTHER ARMADA WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8505674 ↗
• MalfunctionMar 9, 2018Difficult To Position; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT AN UN-SPECIFIED LESION. THE 3.0 X 40 MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS STUCK WITH AN UNKNOWN GUIDE WIRE DURING USE. THE BALLOON AND GUIDE WIRE WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT. 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 Consequences Or Impact To Patient

  MAUDE report 7329271 ↗
• MalfunctionJan 29, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, LEFT SUPERFICIAL FEMORAL ARTERY. THE 3.0X60M ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION. THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 8-10 ATMOSPHERES. THE BDC WAS REMOVE WITHOUT ISSUE AND A 3.0X40M ARMADA 14 BDC WAS ADVANCED WITHOUT ISSUE AND IT ALSO RUPTURED DURING THE FIRST INFLATION TO 8-10 ATMOSPHERES. A NEW ARMADA 14 BDC WAS USED TO 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 Consequences Or Impact To Patient

  MAUDE report 7225838 ↗
• MalfunctionJan 26, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE NON-TORTUOUS, HEAVILY CALCIFIED ANTERIOR TIBIAL ARTERY IN THE RIGHT LEG. A 3.0 X 40 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS SELECTED FOR THE PROCEDURE. THERE WERE NO ISSUES NOTED WITH THE PTA CATHETER DURING UNPACKING, INSPECTION AND PREPARATION. THE PTA CATHETER WAS ADVANCED WITH NO RESISTANCE FELT TO THE LESION AND CROSSED. UPON THE FIRST INFLATION TO APPROXIMATELY 6 - 8 ATMOSPHERES THE BALLOON RUPTURED. THE PTA CATHETER WAS REMOVED FROM THE ANATOMY. AN UNSPECIFIED CUTTING/SCORING BALLOON WAS USED AND THEN A NEW 3.0 X 40 MM ARMADA 14 PTA CATHETER WAS USED TO SUCCESSFULLY PERFORM ANGIOPLASTY ON THE LESION. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6281803 ↗