Armada A2020-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648155970), received between Jun 11, 2018 and Feb 6, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE POPLITEAL ARTERY. AFTER A 2X80MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITH NO ISSUES THE BDC WAS ATTEMPTED TO BE USED TO DILATE THE LESION; HOWEVER, DURING ITS FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 14 ATMOSPHERES (ATM). THE BDC WAS REMOVED AND THE VESSEL WAS ATTEMPTED TO BE DILATED WITH A 2X200MM ARMADA 14 BDC, AFTER BEING PRE-PREPARED WITH NO ISSUES, BUT DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 12ATM. THE BDC WAS REMOVED AND REPLACED WITH A SAME SIZED ARMADA 14 BDC AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326969 ↗
• MalfunctionOct 23, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 2.0X80MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, A BALLOON RUPTURE OCCURRED AFTER 2 INFLATIONS AT 6 ATMOSPHERES. THE BDC WAS REMOVED FROM THE PATIENT AND ANOTHER ARMADA BALLOON WAS USED TO COMPLETE 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 17992852 ↗
• MalfunctionJun 2, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 60% STENOSED LESION IN THE ANTERIOR TIBIAL ARTERY. IT WAS OBSERVED THAT THE COATING OF AN HT COMMAND ES GUIDE WIRE (GW) WAS DISCOLORED FOR APPROXIMATELY 2 TO 3CM. IT ALSO FELT ROUGHER COMPARED TO THE REST OF THE HYDROPHILIC COATING. THE GW WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER, THE HYDROPHILIC COATING WAS PEELING OFF VERY QUICKLY AND SHEARED OFF WHEN LOADING AN ARMADA 14 BALLOON ONTO THE GUIDE WIRE. RESISTANCE WAS NOTICED DURING REMOVAL OF THE GW FROM THE ANATOMY AND WITH REMOVAL OF THE ARMADA BDC FROM THE GW AS WELL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575115 ↗
• MalfunctionFeb 23, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT PERONEAL ARTERY. A 2X80MM ARMADA 14 BALLOON WAS ADVANCED TO THE LESION. WHEN INFLATED, IT WAS NOTED THAT CONTRAST WAS LEAKING FROM THE BALLOON. THE DEVICE WAS REMOVED AND REPLACED WITH A 2X120MM ARMADA 14 BALLOON TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 13585775 ↗
• MalfunctionFeb 22, 2022Stretched; Difficult to Advance; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY (ATA) WITH STRONG CALCIFICATION AND A NON-TREATABLE KINK IN THE ARTERY DUE TO FRACTURE OF THE TIBIA AND FIBULA. THE 2.0X80 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WORKED PROPERLY WHEN IT WAS FIRST ADVANCED ONTO A GUIDE WIRE. HOWEVER, WHEN THE ARMADA 14 PTA CATHETER WAS REMOVED FROM THE WIRE, RINSED AND THREADED ONTO A NON-ABBOTT GUIDE WIRE, IT WAS NO LONGER ABLE TO ADVANCE. A NEW CATHETER WAS USED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED A STRETCHED PROXIMAL SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581245 ↗
• MalfunctionOct 15, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY IN THE PERONEAL ARTERY. A COMMAND GUIDE WIRE WAS ADVANCED TO THE LESION. THEN, A 2 X 80 MM ARMADA 14 BALLOON CATHETER WAS ADVANCED; HOWEVER, AFTER PROPERLY CONNECTED THE INFLATION DEVICE AND INFLATING THE BALLOON 3 TO 4 TIMES AT 8 TO 10 ATMOSPHERES, IT WAS NOTED THAT THE DYE WAS COMING BACK FROM THE HUB. ANOTHER UNSPECIFIED BALLOON CATHETER 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 Consequences Or Impact To Patient

  MAUDE report 10686227 ↗
• MalfunctionAug 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION IN THE TIBIAL ARTERY. DURING USE, THE ARMADA 14 DILATATION CATHETER BALLOON RUPTURED AT AN UNKNOWN PRESSURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. A SECOND SAME DEVICE WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10417780 ↗
• MalfunctionMar 25, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY. A HT COMMAND ES GUIDE WIRE WAS ADVANCED TO THE LESION AND A 2.0X80MM ARMADA 14 BALLOON CATHETER WAS ADVANCED OVER THE GUIDE WIRE WITHOUT ISSUES. THE BALLOON CATHETER WAS REMOVED AND AN ATTEMPT TO ADVANCE AN UNSPECIFIED 014 LASER CATHETER OVER THE GUIDE WIRE WAS MADE; HOWEVER, RESISTANCE WAS FELT. THE GUIDE WIRE WAS REMOVED, AND A NON-ABBOTT GUIDE WIRE WAS ADVANCED. THE LASER CATHETER WAS ADVANCED OVER THE NON-ABBOTT GUIDE WIRE WITHOUT ISSUES AND THE LESION WAS LASERED. THE LASER CATHETER WAS REMOVED, AND THE SAME ARMADA 14 BALLOON CATHETER WAS ADVANCED ON THE NON-ABBOTT GUIDE WIRE. THE NON-ABBOTT GUIDE WIRE WAS REMOVED, AND THE BALLOON CATHETER WAS USED AS AN EXCHANGE CATHETER. A NEW HT COMMAND ES GUIDE WIRE WAS ADVANCED THROUGH THE BALLOON CATHETER AND THE LESION WAS DILATED. DURING REMOVAL OF THE GUIDE WIRE, RESISTANCE WAS FELT WITH THE BALLOON CATHETER AND BOTH WERE REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 9878950 ↗
• MalfunctionJan 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HIGHLY CALCIFIED POSTERIOR TIBIAL ARTERY. DURING THE INITIAL INFLATION OF A 2.0X80MM ARMADA 14 BALLOON DILATATION CATHETER THE BALLOON BURST AT AN UNSPECIFIED ATMOSPHERE. ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9612939 ↗
• MalfunctionAug 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE ANTERIOR TIBIAL VEIN. A 2.0 X 40 MM AND 2.0 X 80 MM ARMADA BALLOON DILATATION CATHETERS (BDC) RUPTURED. ONE BALLOON WAS INFLATED ONCE, THE OTHER BALLOON WAS INFLATED TWICE. BOTH WERE INFLATED TO NOMINAL PRESSURE AND BOTH RUPTURED AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED AFTER USE OF THE DEVICES WITH SATISFACTORY RESULTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8908440 ↗
• MalfunctionJun 11, 2018Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MILDLY TORTUOUS, MILDLY CALCIFIED, DISTAL, ANTERIOR TIBIAL ARTERY. A 2.0 X 80 MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS SELECTED FOR THE PROCEDURE. AIR ASPIRATION WAS NOT PERFORMED PRIOR TO USE. THE PTA CATHETER WAS ADVANCED TO THE LESION WITH NO RESISTANCE FELT AND ON THE FIRST INFLATION TO 7 ATMOSPHERES THE BALLOON RUPTURED. THE PTA CATHETER WAS REMOVED FROM THE ANATOMY AND REPLACED WITH A NEW 2.0 X 80 MM ARMADA 14 PTA 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 7587561 ↗