Armada B1050-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648154614), received between Feb 1, 2017 and Apr 23, 2026 — classified as 2 injuries, 10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN UNKNOWN ARTERY. THE 5.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED FOR USE WITHOUT ISSUE. THE BDC WAS ADVANCED TO THE TARGET LESION AND INFLATED NORMALLY. UPON DEFLATION AND ASPIRATION, AIR BUBBLES WERE NOTED IN THE INDEFLATOR. THE DEVICE WAS REMOVED WITHOUT ISSUE. A SECOND ARMADA 35 WAS BEING PREPARED OUTSIDE THE PATIENT ANATOMY WHEN AIR BUBBLES WERE NOTED DURING ASPIRATION. A LEAK WAS SUSPECTED FROM THE HUB. A THIRD ARMADA 35 DEVICE 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 24966318 ↗
• InjuryJan 14, 2026Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  SUBSQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THAT THERE WAS NO HOSPITALIZATION AND THERE WAS NO REPORT OF POSTOPERATIVE WORSENING. THE PATIENT IMPROVED AS SCHEDULED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24073036 ↗
• MalfunctionAug 22, 2024Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ILIAC ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. AN UNSPECIFIED GUIDE WIRE CROSSED THE LESION AND THE 5X60 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS NOT PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THE DEVICE WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 5 ATMOSPHERES. A DRUG COATED BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20032123 ↗
• MalfunctionDec 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT PRIOR TO USE THE 5.00X60MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY. THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE BDC WAS ADVANCED TO THE TARGET LESION. DURING THE SECOND INFLATION TO THE RATED BURST PRESSURE (RBP), THE BALLOON RUPTURED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO DELAY CLINICALLY SIGNIFICANT REPORTED IN THE PROCEDURE. THE FINAL OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928999 ↗
• MalfunctionAug 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A 100% STENOSED DE NOVO LESION IN THE ATRIOVENTRICULAR FISTULA. AN ARMADA 35 5 MM/60 MM WAS INSERTED AND ADVANCED TO THE TARGET LESION. HOWEVER, THE BALLOON RUPTURED AFTER INFLATING IT TO 3 ATMOSPHERES. THE DEVICE WAS REMOVED AND REPLACED WITH THE SAME SIZE. 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 12309012 ↗
• MalfunctionMay 6, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS NO DEVICE ISSUE NOTED DURING PREPARATION OF THE ARMADA 35 DILATATION CATHETER. THE ARMADA 35 WAS INSERTED TO TREAT A DIALYSIS FISTULA IN THE ARM. WHEN ATTEMPT WAS MADE TO INFLATE THE ARMADA 35, A LEAK WAS NOTED AT THE TAPERED SHAFT/HUB CONNECTION. NO AIR ENTERED THE PATIENT. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER ARMADA 35 OF THE SAME SIZE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10029679 ↗
• InjuryApr 1, 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 THE PROCEDURE WAS PERFORMED TO TREAT A RE-STENOSED LESION IN THE MODERATELY CALCIFIED, MILDLY TORTUOUS, 70% STENOSED RADIAL ARTERY WITH A FISTULA. A 5X60MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS INFLATED ABOVE RATED BURST PRESSURE TO 20 ATMOSPHERES AND RUPTURED. AFTER DEFLATION, THE BALLOON SEPARATED FROM THE CATHETER, AND THE CATHETER FACED RESISTANCE DURING REMOVAL WITH THE ANATOMY. THE SEPARATED PORTION WAS RETRIEVED THROUGH A PUNCTURE IN THE BRACHIAL ARTERY WITH AN UNSPECIFIED SHEATH. NO PORTION OF THE DEVICE REMAINS IN THE ANATOMY. THERE WERE NO ADVERSE PATIENT SEQUELAE, BUT THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9910689 ↗
• MalfunctionOct 11, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE BALLOON OF A 5X60MM ARMADA 35 BALLOON CATHETER RUPTURED AND FAILED TO INFLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 5X60MM 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 9181273 ↗
• MalfunctionMay 5, 2017Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED ILIAC ARTERY. A 5.0 X 60 MM ARMADA 35 BALLOON CATHETER WAS INFLATED ONE TIME WITH A SYRINGE; HOWEVER, WHEN USING THE SYRINGE TO DEFLATE THE BALLOON, THE DEFLATION WAS VERY SLOW; ALTHOUGH, IT DID FULLY DEFLATE. IT IS UNKNOWN HOW LONG IT TOOK TO DEFLATE. A SECOND ARMADA 35 WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6549683 ↗
• MalfunctionMar 14, 2017Insufficient Cooling; Deflation Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN A 75% STENOSED CEPHALIC VEIN. THE 5.0MMX60MMX80CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER THE BALLOON ONLY PARTIALLY INFLATED. NEGATIVE WAS HELD FOR SEVERAL MINUTES AND THE BALLOON DID NOT COMPLETELY DEFLATE. ALTHOUGH THE BALLOON REMAINED PARTIALLY INFLATED, THE BDC WAS ABLE TO BE REMOVED WITHOUT ISSUE. A 5X60 MM NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6404281 ↗
• MalfunctionFeb 21, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE ARMADA 35 5MM/60MM 80CM BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. A NON-ABBOTT BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH OR DURING ADVANCEMENT TO THE LESION. 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 6345796 ↗
• MalfunctionFeb 1, 2017Deflation Problem; Difficult to Remove; Physical Property Issue

  IT WAS REPORTED THAT AFTER UNPACKAGING AND PREPPING A 5.0MM X 60MM X 80CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WITHOUT ISSUE, THE BDC WAS ADVANCED VIA RIGHT BRACHIAL ACCESS TO A NON-CALCIFIED, NON-TORTUOUS ARTERIO-VENOUS (AV) FISTULA WITHOUT RESISTANCE. THE ARMADA 35 WAS INFLATED WITHOUT DIFFICULTY, BUT INFLATION REPORTEDLY FELT UNUSUAL. DILATATION WAS COMPLETED WITHOUT DIFFICULTY, HOWEVER, THE BALLOON WAS UNABLE TO BE DEFLATED AT ALL AND WAS CONSEQUENTLY DIFFICULT TO REMOVE FROM THE AV FISTULA. FORCE WAS APPLIED TO RETRACT AND WEDGE THE INFLATED BALLOON INTO THE GUIDING CATHETER THEN ALL DEVICES WERE WITHDRAWN FROM THE ANATOMY AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6294284 ↗