Armada B1080-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648154881), received between Mar 10, 2017 and Nov 26, 2025 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS FISTULA IN A MILDLY TORTUOUS SUBCLAVIAN VEIN THAT IS 80% STENOSED. ONCE AT THE FISTULA, THE 8.0X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) RUPTURED AT 22 ATMOSPHERES DURING THE 1ST INFLATION. RESISTANCE WAS NOTED DURING WITHDRAWAL AND FORCE WAS APPLIED. IT IS UNKNOWN WHAT THE RESISTANCE WAS DUE TO. THE BALLOON SEPARATED AND WAS RETRIEVED BY CUT DOWN. ANOTHER DEVICE WAS NOT USED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662850 ↗
• MalfunctionSep 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED LESION IN THE RADIAL ARTERY WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 8.0X80MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, A RUPTURE OCCURRED AT 5 ATMOSPHERES DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER ARMADA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777526 ↗
• InjuryAug 25, 2023Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED VEIN. THE 8.0X80MM ARMADA BALLOON RUPTURED DURING INFLATION AT AN UNKNOWN PRESSURE. A PIECE OF THE BALLOON SEPARATED AND WAS LEFT INSIDE THE PATIENT. THEREFORE, A STENT WAS USED TO EMBED THE PIECE OF THE BALLOON AGAINST THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17624283 ↗
• MalfunctionAug 10, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY STENOSED AXILLARY ARTERY. THE 8X80MM ARMADA 35 BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE. NO RESISTANCE WAS FELT WHEN ADVANCING THE BALLOON CATHETER. THE BALLOON RUPTURED DURING THE THIRD INFLATION AT 14 ATMOSPHERES (BALLOON WAS INFLATED TO 14 ATMS EACH TIME). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ARMADA BALLOON CATHETER. 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 17503974 ↗
• InjuryApr 5, 2023Difficult 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 LEFT COMMON ILIAC ARTERY. THE 8X80MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED; HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 10 ATMOSPHERE DUE TO SHARP CALCIFICATION. DURING REMOVAL, RESISTANCE WAS NOTED WITH THE UNSPECIFIED SHEATH AND GUIDE CATHETER, AND THE SHAFT SEPARATED. THE PATIENT WAS TAKEN TO SURGERY TO REMOVE THE SEPARATED PORTION SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686580 ↗
• MalfunctionNov 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE AV SHUNT WITH DIFFUSE MILD CALCIFICATION, MILD TORTUOSITY AND 70% STENOSIS. THE 8X80 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES DURING USE. A NEW ARMADA 35 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 15839579 ↗
• InjuryOct 5, 2021Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT POPLITEAL VEIN. AN 8X80MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED WITHOUT RESISTANCE, BUT THE BALLOON RUPTURED DURING THE FIRST INFLATION BELOW RATED BURST PRESSURE. THE PTA BALLOON HAD RESISTANCE WITH AN UNSPECIFIED GUIDE WIRE DURING REMOVAL, SO FORCE WAS APPLIED. A PORTION OF THE BALLOON HAD SEPARATED, SO AN UNSPECIFIED STENT WAS USED TO EMBED THE SEPARATED PORTION AND SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12578214 ↗
• InjuryAug 31, 2021Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CEPHALIC VEIN THAT IS 70% STENOSED. THE 8X80MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED AT 13 ATMOSPHERES. DURING REMOVAL RESISTANCE WAS MET WITH ANATOMY AND THE DISTAL END (TIP) WAS SEPARATED. THE SEPARATED PORTION WAS ATTEMPTED TO BE SNARED; HOWEVER, IT WAS UNSUCCESSFUL. AN OCCLUSION OCCURRED WITHIN THE VESSEL AND THE TIP EMBOLIZED IN THE LEFT PULMONARY ARTERY. NO FURTHER TREATMENT WAS PROVIDED. PATIENT IS NOTED TO BE DOING WELL AND FEELS FINE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 12392348 ↗
• InjurySep 10, 2020Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE BASILIC VEIN. AN 8X80MM ARMADA 35 BALLOON CATHETER WAS INFLATED TWO TIMES; HOWEVER, THE BALLOON RUPTURED CIRCUMSTANTIALLY DURING THE SECOND INFLATION AT 14 ATMOSPHERES. DURING REMOVAL OF THE BALLOON CATHETER RESISTANCE WITH THE INTRODUCER SHEATH WAS FELT AND THE DISTAL PORTION OF THE RUPTURED BALLOON SEPARATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY DEPLOYING AN 8X60MM ABSOLUTE PRO STENT TO EMBED THE SEPARATED BALLOON PIECE AGAINST THE VESSEL WALL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10516411 ↗
• MalfunctionNov 12, 2019Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED. THE LESION THAT WAS TREATED WAS THE LEFT BRACHIOBASILIC ARTERIOVENOUS FISTULA. THE DEVICE WAS INFLATED TWICE AT 17 ATMOSPHERES (ATM), AND THE BALLOON RUPTURED AT 17 ATM. THE ARMADA 35 BALLOON CATHETER DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311833 ↗
• InjuryAug 5, 2019Off-Label Use; Material Rupture; Material Separation; Off-Label Use; Material Rupture; Material Separation

  IT WAS REPORTED THAT AN 8X80MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED. DURING WITHDRAWAL, THE MARKER SEPARATED FROM THE CATHETER IN THE SUBCLAVIAN ARTERY. THE MARKER THEN MIGRATED TO THE PULMONARY ARTERY. A SNARE WAS ATTEMPTED SEVERAL TIMES TO RETRIEVE THE MARKER BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS THEN COMPLETE AND COMPUTED TOMOGRAPHIC (CT) ANGIOGRAPHY WAS PERFORMED TO EVALUATE THE PATIENT, WHICH DID NOT IDENTIFY ANY PULMONARY EMBOLISM. THE PATIENT WAS EXPECTED ON (B)(6) 2019 FOR A FOLLOW UP EVALUATION. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: "DURING AN INTERVENTIONAL RADIOLOGY PROCEDURE, RIGHT ARM FISTULOGRAM, THE BALLOON CATHETER RUPTURED AND WHILE ATTEMPTING TO WITHDRAW THE CATHETER FROM THE BODY, THE MARKET TIP SEPARATED FROM THE CATHETER IN THE SUBCLAVIAN ARTERY. THE CATHETER MARKER TIP MIGRATED TO PULMONARY ARTERY. THE DR ATTEMPTED MULTIPLE TIMES TO SNARE THE MARKER TIP AND WAS SUCCESSFUL. THE DR ENDED THE CASE AND SEND PT TO CT FOR FURTHER EVALUATION. FDA SAFETY REPORT ID#(B)(4)."

  Patient problems: Foreign Body In Patient

  MAUDE report 8860162 ↗
• MalfunctionApr 12, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS A LESION LOCATED IN THE BASILIC VEIN USING 8 MM X 80 MM ARMADA 35 BALLOON CATHETER FOR POST-DILATATION OF A DEPLOYED STENT. REPORTEDLY, THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT TO THE STENT. DURING THE FIRST INFLATION OF THE BALLOON AT 2 ATMOSPHERES, THE BALLOON RUPTURED. ANOTHER NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 7427127 ↗
• MalfunctionMay 3, 2017Inflation Problem; Material Rupture

  IT WAS REPORTED THAT AN ARMADA BALLOON WAS TREATING AN UPPER ARM FISTULA WITH MODERATE CALCIFICATION. THE DEVICE ADVANCED WITHOUT AN ISSUE TO THE TREATMENT SITE AND INFLATION WAS ATTEMPTED. THE BALLOON FAILED TO INFLATE AND A HOLE IN THE DEVICE WAS SUSPECTED. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY. ANOTHER DEVICE USED IN REPLACEMENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6541261 ↗
• MalfunctionMar 10, 2017Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN THE LEFT BRACHIAL ARTERY USING A 7FR SHEATH. THE ARMADA 35 WAS INFLATED AT THE STENOSIS WITH THE PRESSURE GUN AT 13 ATMOSPHERES WHEN IT PRESENTED A WAIST IN THE BALLOON AND WAS OOZING (LEAKING) DEVELOPER AT THE JUNCTION OF THE BALLOON AND THE CATHETER. SO TREATMENT WITH A NON-ABBOTT BALLOON CATHETER WAS USED TO HANDLE THE SYMPTOMS OF THE STENOSIS AND THEN SURGERY WAS SUCCESSFUL. THERE WERE NO ADVERSE PATIENT SEQUALEA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6395315 ↗