Armada B1060-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648154720), received between Aug 1, 2019 and May 21, 2024 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE ILIAC ARTERY. THE 6.0X100MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE CALCIFICATION. THE BALLOON WAS INFLATED TWICE AND DURING THE SECOND INFLATION THE BALLOON RUPTURED AT 9.5 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19358162 ↗
• MalfunctionJul 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING DILATATION OF AN UNSPECIFIED LESION, THE 6.0X100MM ARMADA BALLOON RUPTURED AT 10 ATMOSPHERES. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393652 ↗
• InjuryApr 21, 2021Entrapment of Device; Material Rupture; Material Separation; Entrapment of Device; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS BRACHIAL VEIN. THE 6X100MM ARMADA 35 BALLOON WAS INFLATED TO NOMINAL AND IT RUPTURED ON THE FIRST INFLATION AT 6ATM. THE BALLOON SEPARATED AND GOT STUCK IN THE PATIENT. A CUTDOWN WAS PERFORMED TO RETRIEVE THE SEPARATED BALLOON. A SAME SIZE NON-ABBOTT BALLOON WAS USED TO TREAT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701175 ↗
• MalfunctionApr 14, 2021Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN ARMADA 18 AND AN ARMADA 35 BALLOON WITH PREPARED OUTSIDE THE ANATOMY BUT WERE NOT SOAKED IN SALINE PRIOR TO USE, ONLY WIPED DOWN. THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL POPLITEAL ARTERY THAT HAD SIGNIFICANT ECCENTRIC CALCIUM AND WAS 90% STENOSED. AFTER ADVANCEMENT TO THE LESION WITHOUT ISSUE, THE ARMADA 18 BALLOON RUPTURED DURING THE FIRST INFLATION AT 16 ATMOSPHERES (ATM). AFTER ADVANCEMENT TO THE LESION WITHOUT ISSUE, THE ARMADA 35 BALLOON RUPTURED DURING THE FIRST INFLATION AT 14 ATM. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AN ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11668345 ↗
• InjuryMar 12, 2021Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance; Difficult to Remove; Material Rupture; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY, AND 80% STENOSIS IN THE FEMORAL ARTERY. REPORTEDLY, A 6.0 X 100 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR DILATATION; HOWEVER, RESISTANCE WAS FELT DUE TO THE ANATOMY AND THE BALLOON RUPTURED DURING FIRST INFLATION AT NOMINAL PRESSURE. DURING REMOVAL, RESISTANCE WAS NOTED WITH THE SHEATH AND THE DISTAL PART OF THE BALLOON SEPARATED AND REMAINED IN THE ARTERY. AN ABSOLUTE STENT WAS DEPLOYED TO COVER (EMBED) THE SEPARATED BALLOON MATERIAL TO AVOID DISTAL EMBOLIZATION. A NEW 7.0 X 120 MM ARMADA 35 BDC WAS THEN ADVANCED TO EXPAND THE STENT BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT NOMINAL PRESSURE. ON REMOVAL, RESISTANCE WAS NOTED WITH THE SHEATH AND THE DISTAL PART OF THE BALLOON SEPARATED AND REMAINED IN THE ARTERY. ANOTHER ABSOLUTE STENT WAS DEPLOYED TO COVER (EMBED) THE SEPARATED BALLOON MATERIAL. AN UNSPECIFIED BDC WAS THEN USED AND THE TARGET LESION WAS TREATED. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11477750 ↗
• InjurySep 23, 2020Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON FEMORAL ARTERY WITH MODERATE TO SEVERE STENOSIS. A 6MMX100MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS TAKEN TO THE LESION AND RUPTURED CIRCUMFERENTIALLY ON THE 2ND INFLATION AT 12 ATMOSPHERES (ATM). DURING REMOVAL, THE BALLOON BUNCHED AND THE BDC COULD NOT BE REMOVED FROM THE DISTAL END OF THE SHEATH. A CUT DOWN AND ARTERIOTOMY WAS PERFORMED TO REMOVE THE RUPTURED BALLOON. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10577745 ↗
• InjuryNov 21, 2019Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE SIGNIFICANTLY NARROWED LEFT SUPERFICIAL FEMORAL ARTERY. THE ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS BEING USED FOR POST-DILATATION OF AN ABSOLUTE STENT. THE BALLOON WAS INFLATED ONCE TO 13 ATMOSPHERES AND RUPTURED AND SEPARATED FROM THE CATHETER. DURING WITHDRAWAL OF THE RUPTURED BALLOON, SOME RESISTANCE WAS NOTED AT THE TIP OF THE SHEATH. THE PATIENT WAS SENT TO SURGERY AND THE SEPARATED PORTION WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9356494 ↗
• InjuryAug 1, 2019Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A SUPERFICIAL FEMORAL ARTERY. A 6.0X100MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PRESSURIZED TO AN UNSPECIFIED PRESSURE AND THE BALLOON RUPTURED. DURING REMOVAL OF THE BDC, THERE WAS RESISTANCE NOTED WITH THE ANATOMY AND THE BALLOON SEPARATED FROM THE CATHETER. IT WAS REPORTED THAT THE SEPARATED BALLOON WAS REMOVED BUT THE METHOD IS UNKNOWN. A NEW UNSPECIFIED BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8852466 ↗