Armada B1060-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648154713), received between Jul 24, 2019 and Feb 4, 2026 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY TORTUOUS, SEVERELY STENOSED LEFT AV FISTULA GRAFT IN THE UPPER EXTREMITY. DURING ADVANCEMENT OF THE 6.0X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET DUE TO ANATOMY. THE ARMADA BDC WAS UNABLE TO OPEN STENOSIS WITH NO CLINICAL RESOLUTION WHEN THE BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. A NEW ARMADA 35 BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24262812 ↗
• MalfunctionNov 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT AV FISTULA IN THE ARM WITH TIGHT STENOSIS. THE 6X80 ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. A 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23526634 ↗
• MalfunctionMar 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED CEPHALIC VEIN LESION. A 6X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. ANOTHER ARMADA 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18914149 ↗
• MalfunctionNov 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LOWER EXTREMITY. FOUR BALLOON DILATATION CATHETERS (BDCS), 7.0X80MM ARMADA 35, 6.0X80MM ARMADA 35, AND TWO 3.0X60MM ARMADA 18S WERE INFLATED AT AN UNKNOWN PRESSURE BUT ALL BURST BEFORE REACHING NOMINAL PRESSURE. ANOTHER ABBOTT 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 18067491 ↗
• MalfunctionMay 8, 2023Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method; Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CEPHALIC ARCH WITH NO TORTUOSITY AND HEAVY CALCIFICATION. THE 6X80 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT ISSUE AND WAS INFLATED. ON THE THIRD INFLATION AT 22 ATMOSPHERES, THE BALLOON RUPTURED. THE FIRST TWO INFLATIONS WERE TO 16 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 16887581 ↗
• MalfunctionFeb 10, 2023Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance; Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LEFT AV LOOP GRAFT ANASTOMOSIS LESION WITH MODERATE TORTUOSITY AND SEVERE STENOSIS. AFTER PRE-DILATATE THE LESION WITH A 6MM/80MM 35 ARMADA BALLOON A RUPTURE OCCURRED IN THE FIRST INFLATION AT 14 ATMOSPHERES. RESISTANCE WAS MET DURING ENTRY AND REMOVAL. DURING REMOVAL FORCED WAS APPLIED AND THE BALLOON WAS DETACHED INSIDE THE GUIDE CATHETER. ANOTHER ARMADA BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16354058 ↗
• MalfunctionOct 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN A LEFT ARTERIOVENOUS (AV) FISTULA WITH MODERATE CALCIFCATION. THE 6.00X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION; HOWEVER, A RUPTURE OCCURRED AT 12 ATMOSPHERES AFTER SECOND INFLATION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER BDC WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15671436 ↗
• MalfunctionFeb 23, 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 HEAVILY CALCIFIED CEPHALIC VEIN. THE 6X80MM ARMADA 35 WAS ADVANCED WITH NO RESISTANCE AND ONCE AT THE LESION DURING THE 4TH INFLATION AT 18 ATMOSPHERES THE BALLOON RUPTURED. ANOTHER NON-ABBOTT BALLOON WAS USED 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 13588618 ↗
• InjuryOct 27, 2021Difficult 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 THE PROCEDURE WAS TO TREAT A LESION IN THE ATRIOVENTRICULAR (AV) FISTULA. A 6X80MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE AND WAS INFLATED THE FIRST TIME, 1 ATMOSPHERE ABOVE THE RATED BURST PRESSURE (RBP). THE SECOND INFLATION WAS TO 14 ATM WHEN THE BALLOON RUPTURED AT THE LESION. DURING WITHDRAWAL OF THE RUPTURED BALLOON, RESISTANCE WAS FELT BETWEEN THE RUPTURED BALLOON AND THE ANATOMY, AND THE BALLOON SEPARATED IN THE AV FISTULA. THE FISTULA HAD TO BE CUT OPEN AND THE RUPTURED BALLOON PIECE REMOVED, ENDING THE PROCEDURE. THERE WAS A REPORTED DELAY IN THE PROCEDURE DUE TO THE CUT DOWN, BUT NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707275 ↗
• InjuryOct 25, 2021Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT ILIAC ARTERY THAT IS 70% STENOSED. AN UNSPECIFIED 6FR SHEATH WAS USED WITH A NON-ABBOTT GUIDE WIRE. THE LESION WAS PRE-DILATED WITH A 6X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) AND THE LESION WAS STENTED WITH A NON-ABBOTT STENT SUCCESSFULLY. THE ARMADA 35 BALLOON WAS ADVANCED OVER THE WIRE AND INFLATED AT NOMINAL PRESSURE. THE BALLOON RUPTURED AT 8 ATMOSPHERES, WHICH WAS OBSERVED VIA FLUOROSCOPY AND THE DEVICE PRESSURE WENT TO ZERO. WHEN ATTEMPTING TO REMOVE THE BDC RESISTANCE WAS FELT WITH THE BALLOON ITSELF AND THE SHAFT SEPARATED. THE DELIVERY SYSTEM WAS PARTLY REMOVED THROUGH THE 6FR SHEATH; HOWEVER, THE OTHER SEPARATED PORTION REMAINED LOOSE IN THE PATIENT OVER THE GUIDE WIRE. THE 6FR SHEATH WAS REMOVED AND A 8FR SHEATH WAS ADVANCED AND A SECOND NON-ABBOTT GUIDE WIRE WAS PLACED NEXT TO THE FIRST GUIDE WIRE. A 8.0X40MM NON-ABBOTT STENT WAS ADVANCED OVER THE GUIDE WIRE AND PLACED OVER THE SEPARATED BALLOON PORTION TO FULLY EMBED INTO THE VESSEL WALL. POST DILATATION WITH A 6.0X20MM NON-ABBOTT HIGH PRESSURE BALLOON WAS PERFORMED AND FLOW IN THE ARTERY WAS NOTED TO BE SATISFAC

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12688941 ↗
• InjuryOct 18, 2021Difficult to Remove; Material Rupture; Stretched; Difficult to Remove; Material Rupture; Stretched

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT HEAVILY CALCIFIED NE NOVO LESION OF THE LEFT POPLITEAL ARTERY. AN ARMADA 35 6X80 MM WAS INSERTED AND INFLATED TO 12ATM. THE DEVICE FUNCTIONED AS INTENDED, SO THE PHYSICIAN MOVED THE BALLOON PROXIMAL AND INFLATED AGAIN WITH 12ATM. HOWEVER, THIS TIME, THE BALLOON BURST. THE PHYSICIAN THEN ATTEMPTED TO PULL THE BALLOON INTO THE 6F CATHETER BUT WAS UNABLE TO DO SO. ANGIOGRAPHY SHOWED THE BALLOON HAD BECOME STRETCHED AND HAD CURLED UP. THE PHYSICIAN THEN PULLED ALL THE DEVICES BACK TOWARDS THE PUNCTURE SITE. WHILE REMOVING THE DEVICES OUT OF THE PATIENT THROUGH THE COMMON FEMORAL ARTERY, THE BALLOON BECAME STUCK ON THE CATHETER AND ALSO BECAME STUCK IN THE PUNCTURE SITE. FOR REMOVAL, A SURGEON HAD TO SURGICALLY OPEN THE COMMON FEMORAL ARTERY RESULTING IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE DEVICE WAS SUCCESSFULLY REMOVED, AND NO ADDITIONAL TREATMENT WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647653 ↗
• MalfunctionMay 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 6X80MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED AT 15 ATMOSPHERES. AN UNSPECIFIED DEVICE 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 10096160 ↗
• MalfunctionMay 19, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SHAFT OF THE 6X80MM ARMADA 35 BALLOON CATHETER WAS LEAKING AND THE CATHETER DID NOT HOLD PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNSPECIFIED ARMADA 35 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 10071961 ↗
• MalfunctionSep 9, 2019Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ARTERIOVENOUS FISTULA. A 6 X 80 MM ARMADA BALLOON CATHETER RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WIT A NEW UNSPECIFIED 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 8975847 ↗
• MalfunctionJul 24, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED ARTERIAL VENOUS SHUNT LESION THAT WAS 70% STENOSED. A 6X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 16 ATMOSPHERES ON THE FIRST INFLATION. A NEW UNSPECIFIED BDC WAS USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 8822094 ↗