Armada B1060-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648154744), received between Dec 29, 2020 and Apr 7, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 6.0 X 150 MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER DURING INFLATION, THE BALLOON FAILED TO MAINTAIN PRESSURE AND A POSSIBLE LEAK WAS NOTED AT THE HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER SAME SIZE DEVICE. 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 24799423 ↗
• InjuryOct 22, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6X150MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED FOR DILATING THE VESSEL; HOWEVER, THE BALLOON WAS NOTED TO RUPTURE DURING ITS SECOND INFLATION AT 12ATM. RESISTANCE WAS NOTED DURING THE BDC REMOVAL AND A SURGICAL CUT DOWN WAS PERFORMED TO REMOVE THE DEVICE AND 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 20509774 ↗
• InjuryJul 10, 2023Deflation Problem; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE SEPARATED PORTION WAS NOT REMOVED DURING BYPASS SURGERY AND REMAINS IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17294179 ↗
• MalfunctionJun 22, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE TO TREAT AN UNSPECIFIED LESION, A 6X150 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS BEING ASPIRATED TO REMOVE AIR AND THE AIR JUST KEPT FILLING THE SYRINGE. THE DEVICE WAS NOTED TO HAVE LEAKED NEAR THE SEAL BY THE HUB. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182432 ↗
• MalfunctionMar 2, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE 6.0X150 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY AND INFLATED ONCE TO 16 ATMOSPHERES (ATM) AND RUPTURED. ACCORDING TO THE PHYSICIAN, THE CALCIFIED NODULE CONTRIBUTED TO THE BALLOON RUPTURE. 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 11401835 ↗
• InjuryDec 29, 2020Deflation Problem; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE ARMADA 35 BALLOON DILATATION CATHETER WAS NOT PREPARED PRIOR TO ENTERING THE PATIENT ANATOMY. THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY THAT WAS HEAVILY CALCIFIED. THE ARMADA 35 BALLOON WAS ADVANCED TO THE LESION AND DURING THE FIRST INFLATION RUPTURED AT THE RATED BURST PRESSURE. REMOVAL WAS DIFFICULT AND IT WAS NOTED THAT THE BALLOON WAS ONLY PARTIALLY DEFLATED. A GUIDE WIRE WAS ADVANCED SUBINTIMAL AND THE BALLOON CATHETER SUCCESSFULLY REMOVED. A SUPERA STENT SYSTEM WAS ADVANCED AND DEPLOYED, SUCCESSFULLY ESTABLISHING FLOW TO THE LEG. THE PATIENT WAS REPORTED TO BE DOING WELL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11090301 ↗