Armada B2060-250Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648155338), received between Nov 3, 2017 and May 7, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY THAT IS 70-80% STENOSED. A 6.0X250MM ARMADA 35 BALLOON CATHETER WAS ADVANCED TO THE LESION; HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES THE BALLOON RUPTURED. A NEW ARMADA 35 WAS PREPARED AND USED WITHOUT ISSUE 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 21979086 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). TWO NON-ABBOTT STENTS WERE IMPLANTED AND POST-DILATATION WAS PERFORMED USING A 6.0 X 250 MM ARMADA 35 LL DILATATION CATHETER. A DISSECTION WAS NOTED IN THE MID LEFT SFA AFTER USE OF THE ARMADA 35. AN UNSPECIFIED STENT WAS IMPLANTED AS TREATMENT OF THE DISSECTION. THE CONDITION RESOLVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 18163982 ↗
• MalfunctionSep 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERIOR FEMORAL ARTERY (SFA). THE 6.0X250MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE TO THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM). THE BDC WAS REMOVED WITHOUT ISSUE, AND THE PROCEDURE COMPLETED WITH ANOTHER DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10593875 ↗
• MalfunctionJun 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT LEG SUPERFICIAL FEMORAL ARTERY. THE 6X250MM ARMADA 35 BALLOON RUPTURED AT AN UNKNOWN PRESSURE. THE DEVICE WAS REPLACED WITH A NEW UNSPECIFIED ABBOTT BALLOON 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 10184315 ↗
• InjuryJul 16, 2019Difficult to Remove; Material Rupture; Stretched; Difficult to Remove; Material Rupture; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTALLY OCCLUDED DE NOVO LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE ARMADA WAS ADVANCED TO THE LESION, AND WHEN INFLATED, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT NOMINAL PRESSURE DUE TO THE CALCIFIED ANATOMY. WHEN THE DELIVERY SYSTEM WAS WITHDRAWN, THERE WAS RESISTANCE AND THE BALLOON CAME OUT STRETCHING ON THE GUIDE WIRE. A GLIDE CATHETER WAS USED OVER THE 014 WIRE TO SUCCESSFULLY RETRIEVE THE BALLOON. THE CASE WAS ABORTED. THE PATIENT WILL BE BROUGHT BACK AT A LATER DATE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795683 ↗
• MalfunctionMay 18, 2018Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE PROXIMAL FEMORAL ARTERY THAT WAS NON TORTUOUS, NON CALCIFIED AND 100% STENOSED. PRE-DILATATION WAS PERFORMED USING THE ARMADA 35 6 X 250 MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES, BUT THERE WAS A LEAK BETWEEN THE SHAFT AND CONNECTION CANNULA AND PRE-DILATATION WAS UNSUCCESSFUL. ANOTHER SAME SIZE ARMADA BALLOON WAS USED, BUT THE EXACT SAME ISSUE WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THE PATIENT WAS DISCHARGED FROM CLINIC AFTER THE TREATMENT. 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 7525600 ↗
• MalfunctionMay 18, 2018Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE PROXIMAL FEMORAL ARTERY THAT WAS NON TORTUOUS, NON CALCIFIED AND 100% STENOSED. PRE-DILATATION WAS PERFORMED USING THE ARMADA 35 6 X 250 MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES, BUT THERE WAS A LEAK BETWEEN THE SHAFT AND CONNECTION CANNULA AND PRE-DILATATION WAS UNSUCCESSFUL. ANOTHER SAME SIZE ARMADA BALLOON WAS USED, BUT THE EXACT SAME ISSUE WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THE PATIENT WAS DISCHARGED FROM CLINIC AFTER THE TREATMENT. 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 7525570 ↗
• MalfunctionMar 23, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 6X250MM ARMADA 35 BALLOON CATHETER RUPTURED DURING INFLATION AT 3-4 ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 6X200MM ARMADA 35 BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7367987 ↗
• MalfunctionFeb 14, 2018Inflation Problem

  IT WAS REPORTED THAT A 6X250MM ARMADA 35 BALLOON CATHETER FAILED TO INFLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW ARMADA 35 BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7271344 ↗
• MalfunctionNov 3, 2017Detachment Of Device Component; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED PROXIMAL SUPERFICIAL FEMORAL ARTERY. DURING THE FIRST ATTEMPT TO INFLATE AND DEFLATE A 6.0 X 250 MM ARMADA 35 BALLOON CATHETER THE BALLOON INFLATED AND DEFLATED HOLDING NEGATIVE 3-5 SECONDS; HOWEVER, THE BALLOON WOULD NOT FULLY DEFLATE. THE BALLOON CATHETER WAS REMOVED PARTIALLY DEFLATED. THE SAME BALLOON CATHETER WAS USED TO TREAT A DIFFERENT LESION, WAS INSERTED, NOT INFLATED AND THEN REMOVED STILL PARTIALLY DEFLATED. DURING REMOVAL, THE BALLOON SEPARATED FROM THE INTRODUCER SHEATH WITH A PIECE OF THE BALLOON STUCK INSIDE THE SHEATH. THE DEVICE WAS REMOVED AS A SINGLE UNIT WITH A BALLOON PORTION STILL INSIDE THE SHEATH. ANOTHER BALLOON AND SHEATH WERE USED TO SUCCESSFULLY 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 7000150 ↗