Armada 1013465-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648207877), received between Jun 9, 2021 and Sep 18, 2025 — classified as 1 injury, 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY. A 3.0X60MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS PREPARED AND ADVANCED TO THE LESION WITH NO NOTED ISSUES, AND ATTEMPTED TO BE USED FOR VESSEL DILATATION. HOWEVER DURING THE FIRST INFLATION TO 8ATMS THE BDC WAS NOTED TO BE LEAKING FROM THE SHAFT OF THE DEVICE NEAR THE Y-PORT. THEREFORE THE BDC WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH THE USE OF THE ANOTHER ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23090690 ↗
• MalfunctionJun 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN A VESSEL IN THE LOWER EXTREMITY. A 3.0X60MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR VESSEL DILATATION; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO NOT INFLATE AND A BALLOON RUPTURE WAS NOTED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124150 ↗
• MalfunctionMar 26, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A RESTENOSIS, MODERATELY CALCIFIED RIGHT COMMON ILIAC ARTERY THAT IS 50% STENOSED. THE 3.0X60MM ARMADA BALLOON DILATATION CATHETER (BDC) THROUGH A 7F SHEATH, ACCESSED THE RIGHT COMMON FEMORAL ARTERY AND ADVANCED TO THE LESION. WHEN ATTEMPTING TO INFLATE THE ARMADA BALLOON, THE BALLOON WOULD LOSE PRESSURE AND COMPLETELY FAILED TO INFLATE. A LEAK AT THE HUB WAS ALSO OBSERVED. A NEW 3.0X60MM ARMADA BDC 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 21701331 ↗
• MalfunctionMay 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PERONEAL ARTERY. THE 3X60MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS ATTEMPTED TO BE INFLATED TWICE, HOWEVER, THE BALLOON WAS NOTED TO BE LEAKING CONTRAST. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. AFTER REMOVAL, OUTSIDE THE PATIENT THE BALLOON WAS INJECTED WITH CONTRAST AGAIN AND A HOLE WAS NOTED IN THE BALLOON. ANOTHER ARMADA WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393055 ↗
• 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 18067511 ↗
• 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 18067285 ↗
• MalfunctionNov 2, 2021Material Rupture; Material Rupture

  SUBSEQUENT TO THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE 3X60MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS PREPARED FOR USE WITHOUT ISSUE. THE LESION WAS MODERATELY CALCIFIED. THE BDC WAS ADVANCED AND POSITIONED AT THE TARGET LESION AND INFLATION WAS INITIATED; HOWEVER, THE BALLOON DID NOT HOLD PRESSURE AND CONTRAST COULD BE SEEN EXITING THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738592 ↗
• MalfunctionNov 1, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREP OF A 3X60MM ARMADA 18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, BUBBLES WERE NOTED, AND THE DEVICE FAILED TO HOLD PRESSURE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED A TEAR IN THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12733078 ↗
• InjuryJun 9, 2021Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT. IT WAS CONFIRMED THAT PART OF THE BALLOON DETACHED; PART OF THE MATERIAL WAS ABLE TO BE REMOVED, BUT THE PHYSICIAN WAS NOT ABLE TO REMOVE THE BALLOON MARKER AND DEPLOYED A SUPERA STENT TO COMPRESS THE MARKER AGAINST THE ARTERY WALL.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971595 ↗