Armada B1060-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648154683), received between Nov 1, 2016 and Sep 17, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT PERONEAL ARTERY. THE 2.0X120MM ARMADA 14 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE BDC WAS REMOVED AND THE PROCEDURE COMPLETED USING ANOTHER ARMADA 35. 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 23072065 ↗
• MalfunctionMay 15, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 95% STENOSED LESION IN THE BRACHIAL ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 6X20MM ARMADA BALLOON DILATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT 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 22030714 ↗
• MalfunctionOct 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ILIAC ARTERY WITH MODERATE CALCIFICATION. THE 6.0X20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITHOUT ISSUES AND ADVANCED WITHOUT RESISTANCE; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATMS). ANOTHER DIFFERENT SIZE ARMADA 35 BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20497594 ↗
• MalfunctionSep 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN A MILDLY TORTUOUS AND ECCENTRIC MID LEFT SUPERFICIAL FEMORAL ARTERY THAT WAS 80% STENOSED. A 6.0 X 20 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED AND DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT. HOWEVER, THE BALLOON RUPTURED AT ABOUT 5 ATMOSPHERES (ATMS) BEFORE REACHING THE NOMINAL PRESSURE OF 6 ATMS. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER 6.0 X 20 MM ARMADA 35 BDC 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 7877575 ↗
• MalfunctionJul 3, 2017Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A RIGHT ARM FISTULA WITH 80% STENOSIS. A 6MM X 20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION. DURING THE FIRST INFLATION, TO 24 ATMOSPHERES (ATM) THE BALLOON RUPTURED (RBP). THE ARMADA BDC WAS REPLACED WITH ANOTHER SAME SIZE ARMADA BDC AND DURING THE FIRST INFLATION TO 24 ATM THE BALLOON RUPTURED. A 7MM X 40MM ARMADA BDC WAS ADVANCED TO THE TARGET LESION. DURING THE THIRD INFLATION, TO 24 ATM THE BALLOON RUPTURED. THE 7MM X 40MM ARMADA BDC WAS DIFFICULT TO REMOVE FROM THE SHEATH. THE DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT A PORTION OF THE BALLOON ALONG WITH PART OF THE INNER MEMBER WITH THE BALLOON MARKER REMAINED IN THE PATIENT ANATOMY. AN ATTEMPT TO SNARE THE SEPARATED PORTION OF THE BALLOON WAS UNSUCCESSFUL, A CUT DOWN WAS PERFORMED TO REMOVE THE SEPARATED BALLOON. NO ADDITIONAL TREATMENT WAS REQUIRED; THE PROCEDURE WAS COMPLETE AT THIS TIME. THE PATIENT IS STABLE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6684841 ↗
• MalfunctionJul 3, 2017Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A RIGHT ARM FISTULA WITH 80% STENOSIS. A 6MM X 20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION. DURING THE FIRST INFLATION, TO 24 ATMOSPHERES (ATM) THE BALLOON RUPTURED (RBP). THE ARMADA BDC WAS REPLACED WITH ANOTHER SAME SIZE ARMADA BDC AND DURING THE FIRST INFLATION TO 24 ATM THE BALLOON RUPTURED. A 7MM X 40MM ARMADA BDC WAS ADVANCED TO THE TARGET LESION. DURING THE THIRD INFLATION, TO 24 ATM THE BALLOON RUPTURED. THE 7MM X 40MM ARMADA BDC WAS DIFFICULT TO REMOVE FROM THE SHEATH. THE DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT A PORTION OF THE BALLOON ALONG WITH PART OF THE INNER MEMBER WITH THE BALLOON MARKER REMAINED IN THE PATIENT ANATOMY. AN ATTEMPT TO SNARE THE SEPARATED PORTION OF THE BALLOON WAS UNSUCCESSFUL, A CUT DOWN WAS PERFORMED TO REMOVE THE SEPARATED BALLOON. NO ADDITIONAL TREATMENT WAS REQUIRED; THE PROCEDURE WAS COMPLETE AT THIS TIME. THE PATIENT IS STABLE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6684836 ↗
• MalfunctionJan 12, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) THAT IS ECTATIC WITH HEAVY CALCIFICATION. NO RESISTANCE WAS FELT DURING ADVANCEMENT OF THE THREE ARMADA 35 BALLOON DILATATION CATHETERS (BDC) (6X40MM, 6X20MM, AND 7X40MM) INDIVIDUALLY TO THE LESION; HOWEVER, THEY ALL RUPTURED DURING THE FIRST INFLATION AT NOMINAL PRESSURE. A REPLACEMENT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6247511 ↗
• MalfunctionNov 1, 2016Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION WITH NO TORTUOSITY AND 70% STENOSIS IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE ARMADA 35 BALLOON CATHETER WAS PREPPED OUTSIDE THE ANATOMY PRIOR TO USE USING 50/50 CONTRAST MIX. THE ARMADA 35 WAS ADVANCED TO THE TARGET LESION AND AFTER INFLATION IT WAS DIFFICULT TO DEFLATE THE BALLOON. AFTER SEVERAL ATTEMPTS HOLDING NEGATIVE PRESSURE FOR LESS THAN 20 SECONDS, THE BALLOON DEFLATED. THE PATIENT OUTCOME WAS GOOD. 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 6070752 ↗