Armada B1100-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648154959), received between Jul 3, 2017 and Apr 23, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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.

• MalfunctionApr 23, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED UNSPECIFIED LESION. A 10X60 MM ARMADA 35 PTA BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE AS PER THE INSTRUCTIONS FOR USE WITHOUT ISSUE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION WITHOUT ISSUE. HOWEVER, DURING THE FIRST INFLATION AT 2 ATM, THE BALLOON RUPTURED. AN ADDITIONAL ARMADA 35 BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 24970791 ↗
• MalfunctionApr 11, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT CEPHALIC ARCH. A 10X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED THROUGH RESISTANCE AND ATTEMPTED TO BE USED FOR VESSEL DILATATION; HOWEVER, DURING THE FIRST INFLATION THE BALLOON WAS NOTED TO RUPTURE AT 10ATMS. NO OTHER DEVICES WERE USED AND THE PROCEDURE WAS CONCLUDED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21827120 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT THE 10X60 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER BROKE. THERE WERE NO 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 19460754 ↗
• InjuryJun 6, 2023Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE TIGHTLY STENOSED FISTULA ARTERY. THE 10X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) MET RESISTANCE DURING ADVANCEMENT WITH ANATOMY; HOWEVER, ONCE AT THE LESION THE BDC RUPTURED DURING THE THIRD INFLATION AT 16 ATMOSPHERES. DURING REMOVAL RESISTANCE WAS NOTED WITH ANATOMY, THE BDC INTERNAL CATHETER SEPARATED WITH BOTH MARKERS; HOWEVER, THE PHYSICIAN WAS ABLE TO REMOVE THE PROXIMAL ONE, LEAVING A PIECE OF ONE OF THE RADIAL MARKERS IN THE ANATOMY. A SURGICAL PROCEDURE WAS PERFORMED TO SUTURE THE VESSEL SHUT BECAUSE OF THE TIGHT STENOSIS AND THE FISTULA WAS TO BE DECOMMISSIONED BY SURGICALLY SUTURING THE VESSEL SHUT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17074832 ↗
• InjuryJun 15, 2022Off-Label Use; Difficult to Remove; Material Rupture; Material Separation; Off-Label Use; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SOFT TISSUE TRACT FOR GASTROSTOMY TUBE PLACEMENT. THE 10X60MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED AT AN UNKNOWN PRESSURE DURING THE FIRST INFLATION. DURING REMOVAL RESISTANCE WAS FELT WITH THE DEVICE AND THE TIP SEPARATED APPROXIMATELY 1CM. FLUOROSCOPY REVEALED THE TIP FREELY MOVING IN THE GASTRUM AS WELL AS INTRAGASTRICAL POSITION OF TUBE. IT WAS NOTED THE SMALL TIP FRAGMENT WOULD PASS WITHOUT PATIENT SEQUELAE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14704226 ↗
• InjuryJun 6, 2022Difficult 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 THE SUBCLAVIAN VEIN. THE PATIENT PRESENTED WITH A BLOOD CLOT DUE TO THE NARROWING OF A PREVIOUSLY IMPLANTED STENT THAT WAS PLACED 6-7 YEARS AGO. A 6 FRENCH SHEATH WAS USED AND THE 10X60MM ARMADA BALLOON CATHETER HAD NO RESISTANCE DURING ADVANCEMENT AND WAS INFLATED ONCE AT 11 ATMOSPHERES (ATMS). HOWEVER, THE WASTE OF THE NARROWING OF THE STENT DID NOT RESPOND TO THE DILATATION AND THE BALLOON RUPTURED. THE GUIDE WIRE PORT WAS FLUSHED PRIOR TO USE AND THE BALLOON WAS NOT SOAKED. THE ARMADA WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUES. THE PHYSICIAN PROCEEDED TO REMOVE THE BALLOON BUT RESISTANCE WAS NOTED POSSIBLY BY THE REMAINING RIBS (FIRST AND SECOND RIB REMOVED FROM A PREVIOUS PROCEDURE) DURING WITHDRAWAL. WHEN RESISTANCE WAS FELT, THE BALLOON CATHETER WAS MANIPULATED (ADVANCED AND RETRACTED) TO TRY AND CLEAR IT FROM WHAT WAS CAUSING RESISTANCE. A LITTLE EXTRA FORCE WAS APPLIED TO REMOVE IT AND THE HYPOTUBE AND THE BALLOON SEPARATED FROM THE REST OF THE CATHETER. A SNARE WAS USED AND IT WAS CONFIRMED THAT ALL THE PIECES WERE REMOVED FROM THE PATIENT. A 7 FRENCH SHEATH WAS USED AND A NON-ABBOTT BA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602140 ↗
• MalfunctionJan 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN UNSPECIFIED LESION. THE 10X60MM ARMADA 35 BALLOON SUDDENLY DEFLATED DURING INFLATION [BALLOON RUPTURE}. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11148110 ↗
• MalfunctionNov 13, 2020Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE, A 10.0X100MM ABSOLUTE PRO STENT WAS DEPLOYED ON A BEND. AFTER DILATATION WITH A 10.0X60MM ARMADA 35 BALLOON DILATATION CATHETER, IT WAS OBSERVED THAT MORE THAN ONE STENT STRUT FRACTURED IN THE MIDDLE OF THE STENT BUT THE STENT REMAINED AS ONE. THE FRACTURED STENT REMAINS IN THE PATIENT. 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 10838183 ↗
• MalfunctionOct 2, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF A 10X60MM ARMADA 35 BALLOON CATHETER AIR LEAKAGE WAS DETECTED DURING ASPIRATION. THE BALLOON CATHETER WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED ARMADA 35 BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9147197 ↗
• InjuryJul 3, 2017Detachment Of Device Component; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO TREAT A TARGET LESION IN A VENOUS FISTULA IN THE RIGHT UPPER EXTREMITY. THE 10.0 X 60 MM ARMADA 35 DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 18 ATMOSPHERES. THE DEVICE WAS REMOVED, BUT MET RESISTANCE WITH THE INTRODUCER SHEATH AND THE BALLOON SEPARATED UPON REMOVAL. A SEGMENT OF THE BALLOON REMAINED IN THE ANATOMY. ATTEMPTS WERE MADE TO REMOVE THE SEPARATED SEGMENT, USING A SNARE DEVICE, BUT THE BALLOON SEGMENT REMAINS IN THE ANATOMY. THERE ARE NO PLANS TO REMOVE THE SEPARATED SEGMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6684857 ↗