Armada A2015-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648155932), received between Oct 2, 2018 and May 20, 2024 — classified as 9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR TIBIAL ARTERY. DURING PRE-DILATATION, THE 1.5X20X150CM ARMADA 14 BALLOON WAS ADVANCED BUT THERE WAS NOTED RESISTANCE DURING ADVANCEMENT DUE TO CALCIUM, HOWEVER IT REACHED THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES (ATM). A 1.5X120X150CM ARMADA 14 BALLOON WAS THEN USED BUT THERE WAS NOTED RESISTANCE DURING ADVANCEMENT DUE TO CALCIUM, HOWEVER IT REACHED THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 5ATM. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353762 ↗
• MalfunctionAug 31, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 30% STENOSED, DE NOVO LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. A 1.5X120MM ARMADA 14 BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION TO 24 ATMOSPHERES (ATM). IT IS SUSPECTED THAT THE RUPTURE WAS DUE TO THE CALCIFIED LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER ARMADA BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331495 ↗
• MalfunctionDec 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LEFT TIBIAL ARTERY. AN ARMADA 14 DILATATION CATHETER WAS INSERTED AND ADVANCED TO THE TARGET LESION. HOWEVER, DURING INFLATION, IT RUPTURED AT 10 ATMOSPHERES. THE PHYSICIAN STATED THE BALLOON RUPTURED WAS CAUSED BY A SHARP PIECE OF CALCIFICATION. THE DEVICE WAS REMOVED AND REPLACED WITH A NON-ABBOTT DEVICE AND 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13003264 ↗
• MalfunctionFeb 25, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT AN ANTERIOR TIBIAL ARTERY (ATA). A 1.5X120MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER WAS ADVANCED OVER THE 14 COMMAND GUIDE WIRE TO CROSS A LESION; HOWEVER, THE GUIDE WIRE RETRACTED DUE TO THE CALCIFICATION AND BACK INTO THE BALLOON CATHETER. THE GUIDE WIRE WOULD NOT ADVANCE THROUGH THE DISTAL PORTION OF THE BALLOON CATHETER AND BECAME STUCK WITH THE BALLOON CATHETER. THE GUIDE WIRE AND CATHETER WERE REMOVED TOGETHER. ANOTHER UNSPECIFIED BALLOON AND COMMAND GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11379139 ↗
• MalfunctionFeb 4, 2020Difficult to Remove; Difficult to Advance; Material Twisted/Bent; Difficult to Remove; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED POPLITEAL ARTERY (BTK-BELOW THE KNEE). THE LESION WAS RECANALIZED SUCCESSFULLY WITH THE TIP OF THE COMMAND GUIDE WIRE (GW) IN THE ATERIA DORSALIS PEDIS. AN ARMADA 14 BALLOON WAS THEN USED TO TREAT THE LESION IN THE BTK AREA. DURING ADVANCING THE BALLOON, RESISTANCE WAS MET WITH THE COMMAND GW. IT WAS THEN ATTEMPTED TO STRETCH THE GW TO ASSIST IN ADVANCING THE BALLOON EASIER. THE BALLOON WAS THEN ABLE TO ADVANCE OVER THE GUIDE WIRE AND BE INFLATED AT THE LESION. AS THE GW WAS ATTEMPTED TO BE REMOVED, THEY NOTED THE TIP OF THE WIRE WAS NOT MOVING BECAUSE IT HAD BECOME SEPARATED. THEN DURING ATTEMPTED REMOVAL OF THE ARMADA, THE BALLOON CATHETER GOT TWISTED IN ITSELF AND IT WAS NOT ABLE TO BE REMOVED THROUGH THE 6F SHEATH. IT WAS NOTED THAT RESISTANCE WAS MET WITH THE GW AS WELL. IT WAS THEN DECIDED TO REMOVE THE GW, BALLOON AND SHEATH ALTOGETHER AS A SINGLE UNIT. THE PROCEDURE WAS DEEMED INCOMPLETE. THE NEXT DAY A RE-INTERVENTION WITH A SNARE DEVICE WAS DONE TO REMOVE THE SEPARATED TIP. IT WAS NOTED THAT THE TIP WAS KINKED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9664398 ↗
• MalfunctionDec 17, 2019Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 70% STENOSED AND TORTUOUS LESION IN THE DISTAL POSTERIOR TIBIAL ARTERY. RESISTANCE WAS FELT WHEN ADVANCING A 1.5X120MM ARMADA 14 BALLOON CATHETER AND THE BALLOON RUPTURED DURING THE FIRST INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 1.5X120MM 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 Consequences Or Impact To Patient

  MAUDE report 9477714 ↗
• MalfunctionJun 10, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY. A 1.5X120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT ISSUE; HOWEVER, THE BALLOON BURST DURING THE FIRST INFLATION TO 12 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE. A SECOND 1.5X120MM ARMADA 14 PTA CATHETER WAS THEN ADVANCED WITHOUT ISSUE; HOWEVER, DURING THE INFLATION, A LEAK WAS NOTED WHERE THE HUB AND PROXIMAL SHAFT MEET. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE, AND A NON-ABBOTT BALLOON DEVICE WAS USED TO 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 8683597 ↗
• MalfunctionJun 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY. A 1.5X120MM ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT ISSUE; HOWEVER, THE BALLOON BURST DURING THE FIRST INFLATION TO 12 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE. A SECOND 1.5X120MM ARMADA 14 PTA CATHETER WAS THEN ADVANCED WITHOUT ISSUE; HOWEVER, DURING THE INFLATION, A LEAK WAS NOTED WHERE THE HUB AND PROXIMAL SHAFT MEET. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE, AND A NON-ABBOTT BALLOON DEVICE WAS USED TO 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 8683572 ↗
• MalfunctionOct 2, 2018Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE 1.5X120 MM ARMADA 14 DILATATION CATHETER WAS ADVANCED TO THE NON-TORTUOUS, UNCALCIFIED DISTAL ANTERIOR TIBIAL ARTERY. TWO ATTEMPTS WERE MADE TO INFLATE THE ARMADA 14 TO 8 ATMOSPHERES, BUT THE BALLOON DID NOT FULLY INFLATE. THE ARMADA 14 WAS REMOVED WITHOUT INCIDENT AND A LEAK WAS NOTED COMING FROM A HOLE ON THE ARMADA BALLOON. ANOTHER ARMADA WAS USED SUCCESSFULLY 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 7928265 ↗