Armada B1120-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648155000), received between Apr 16, 2018 and Apr 21, 2025 — classified as 1 injury, 6 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED AV SHUNT WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 12X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED TO 7 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER ARMADA 35 BDC 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 21874138 ↗
• MalfunctionMar 6, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN A FISTULA OF THE LEFT SUBCLAVIAN WITH NO CALCIFICATION OR TORTUOSITY. A LABELED, 12X80X80 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED INTO THE ANATOMY; HOWEVER, WHEN THE BDC WAS INFLATED IT WAS COMPARED TO ANOTHER 12X60X80MM ARMADA BDC AND THE BALLOON MEASURED TO BE 12X60X80MM WHICH DID NOT MATCH THE LABEL ON THE PACKAGING. THE BDC WAS REPLACED WITH ANOTHER ABBOTT DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537953 ↗
• MalfunctionDec 30, 2024Material Rupture; Material Rupture

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED IT WAS NOTED AN UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037571 ↗
• MalfunctionFeb 23, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE BRACHIOCEPHALIC VEIN. A 12X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE AND INFLATED ONE TIME TO UNKNOWN ATMOSPHERES (ATM), WHEN THE BALLOON RUPTURED. DURING REMOVAL, THE BALLOON BECAME STUCK WITH THE SHEATH AND AN UNSPECIFIED WIRE. THE BALLOON CATHETER WAS ABLE TO BE REMOVED FROM THE SHEATH, WITH THE WIRE AS A SINGLE UNIT. THE BALLOON WAS THEN CUT OFF FROM THE WIRE SO THE WIRE COULD BE RE-ADVANCED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW UNSPECIFIED BALLOON DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433140 ↗
• InjuryJan 10, 2020Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A 12X80MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS USED WITH A NON-ABBOTT GUIDE WIRE. THE PTA BALLOON RUPTURED, AND THE CATHETER BECAME STUCK ON THE GUIDE WIRE. A PORTION OF THE MARKER AND BALLOON BECAME SEPARATED IN THE ANATOMY, AND SURGERY WAS PERFORMED TO REMOVE THE SEPARATED PORTIONS. 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 9575058 ↗
• MalfunctionAug 14, 2019Off-Label Use; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Off-Label Use; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN 80% STENOSED LESION IN THE LEFT SUBCLAVIAN VEIN. A 7FR SHEATH WAS ADVANCED AND A 12 X 80 MM ARMADA 35 BALLOON CATHETER WAS ADVANCED WITHOUT RESISTANCE; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 9 ATMOSPHERES. AN ATTEMPT TO REMOVE THE BALLOON CATHETER WAS MADE, BUT THE BALLOON WOULD NOT GO BACK THROUGH THE SHEATH DUE TO THE BALLOON MATERIAL BUNCHING UP AT THE TIP OF THE SHEATH AND BECAME STUCK. AN ATTEMPT TO FORCIBLY REMOVE THE BALLOON CATHETER WAS MADE, BUT THE BALLOON CATHETER SEPARATED INTO TWO PIECES. THE BALLOON CATHETER WAS REMOVED, BUT THE DISTAL TIP OF THE BALLOON MATERIAL REMAINED LODGED IN THE TIP OF THE SHEATH. A BUDDY WIRE WAS PASSED THROUGH THE SITE TO RETAIN WIRE ACCESS AS A NEW PERMA-CATHETER WAS INSERTED. THE OLD WIRE, SHEATH, AND BALLOON REMNANTS WERE REMOVED AS A SINGLE UNIT. A NON-ABBOTT BALLOON CATHETER WAS USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 8895591 ↗
• MalfunctionApr 16, 2018Detachment Of Device Component; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE BRACHIAL ARTERY. A 12X80MM ARMADA 35 BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. RESISTANCE WAS FELT REMOVING THE BALLOON CATHETER AND WAS THOUGHT TO BE WITH THE STRUTS OF A PREVIOUSLY IMPLANTED STENT. THE BALLOON CATHETER WAS REMOVED; HOWEVER, AFTER REMOVAL IT WAS NOTICED THAT THE DISTAL SHAFT, WHERE THE BALLOON IS LOCATED, HAD SEPARATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER REMOVAL OF THE BALLOON CATHETER. 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 7434624 ↗