Armada B2060-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648155253), received between Mar 6, 2017 and Sep 10, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 6.0X20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER THE BALLOON RUPTURED AT A LOW PRESSURE. ANOTHER ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179347 ↗
• MalfunctionMar 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 6MMX20MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 6 ATMOSPHERES (ATM). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535086 ↗
• MalfunctionMay 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. A 6X20MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED, AND THE BALLOON RUPTURED DURING INFLATION. AN UNSPECIFIED BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11765848 ↗
• MalfunctionDec 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS DE NOVO LEFT SUPERFICIAL FEMORAL ARTERY THAT WAS 99% STENOSED. THE LESION WAS APPROACHED VIA THE RIGHT COMMON FEMORAL ARTERY. THE 6X20MM ARMADA 35 BALLOON RUPTURED ON THE FIRST INFLATION AT NOMINAL PRESSURE. THE BALLOON WAS REMOVED AND REPLACED WITH A SAME SIZE NON-ABBOTT BALLOON AND A NON-ABBOTT STENT 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 10959105 ↗
• MalfunctionSep 4, 2020Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6MM X 20MM X 135 CM ARMADA BALLOON DILATATION CATHETER (BDC), A LEAK WAS SEEN COMING FROM A BALLOON PINHOLE. THE BDC WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10497558 ↗
• MalfunctionOct 14, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 6.0X20 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE MILDLY CALCIFIED, RIGHT SUPERFICIAL FEMORAL ARTERY. THE BDC WAS INFLATED TO NOMINAL PRESSURE BUT RUPTURED WITH THE FIRST INFLATION. THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER ARMADA, A 6.0X40, WAS SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 9186869 ↗
• MalfunctionDec 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN ARMADA 35 BALLOON RUPTURED AT 10 ATMOSPHERES. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182730 ↗
• MalfunctionJul 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE 6.0 X 20 MM ARMADA 35 BALLOON RUPTURED DURING INFLATION. NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7675744 ↗
• MalfunctionMar 9, 2018Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT AN UN-SPECIFIED LESION. THE 6 X 20 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED DURING USE. ANOTHER UN-SPECIFIED 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 Consequences Or Impact To Patient

  MAUDE report 7329291 ↗
• MalfunctionMar 21, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED POPLITEAL ARTERY. A 6.0 X 20 MM ARMADA 35 BALLOON CATHETER WAS BEING INFLATED WHEN IT RUPTURED UNDER RATED BURST PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THE TIME OF THE RUPTURE. NO ADDITIONAL TREATMENT WAS PERFORMED. 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 6422217 ↗
• MalfunctionMar 6, 2017Crack; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, DE NOVO LESION IN THE NON-TORTUOUS LEFT ILIAC ARTERY. AFTER PREPPING A 6.0MM X 20MM X 135CM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WITHOUT ISSUE, WITH NEGATIVE PRESSURE DRAWN USING AN INDEFLATOR INFLATION DEVICE, IT WAS ADVANCED TOWARD THE LESION WITHOUT RESISTANCE. PRIOR TO REACHING THE LESION, IT WAS NOTED THAT THE BDC WAS UNABLE TO HOLD THE NEGATIVE PRESSURE. WHILE THERE WAS NO ISSUE WITH CONNECTION AND NO BLOOD WAS NOTED IN THE HUB AREA OF THE DEVICE (NO LEAK IN FLUID PATH), AIR BUBBLES AND A POSSIBLE CRACK WERE NOTED AT THE HUB CONNECTION LUER OF THE ARMADA. THE ARMADA BDC WAS WITHDRAWN FROM THE ANATOMY WITHOUT DIFFICULTY AND DILATATION WAS COMPLETED SUCCESSFULLY WITH THE SAME INDEFLATOR AND A NEW UNSPECIFIED BALLOON. 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 6380657 ↗