Armada B1070-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 08717648154782), received between Aug 9, 2016 and Sep 14, 2026 — classified as 22 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (68 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 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50759508 ↗
• MalfunctionJun 5, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT BILATERAL DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS COMMON ILIAC ARTERY (CIA) LESIONS, EACH WITH 100% STENOSIS. EACH SIDE (LEFT AND RIGHT CIA) WAS ACCESSED VIA IPSILATERAL FEMORAL ACCESS USING A 6F SHEATH AND CROSSED WITH A 0.035-INCH GUIDEWIRE. DURING ADVANCEMENT OF THE 5.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS MET DUE TO ANATOMY. ONCE AT THE RIGHT CIA LESION FOR PREDILATION, THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. A SECOND BALLOON OF THE SAME SIZE WAS USED SUCCESSFULLY TO COMPLETE PREDILATION. THE PROCEDURE WAS THEN PERFORMED ON THE CONTRALATERAL CIA. DURING ADVANCEMENT OF THE 7.0X40MM ARMADA 35 BDC, RESISTANCE WAS MET DUE TO ANATOMY. ONCE AT THE LEFT CIA LESION FOR PREDILATION, THE BALLOON ALSO RUPTURED AT APPROXIMATELY 8 ATMOSPHERES DURING THE FIRST INFLATION. A NEW 7.0X40MM ARMADA 35 BALLOON WAS SUBSEQUENTLY USED TO COMPLETE PREDILATION. A NON-ABBOTT STENT WAS THEN SUCCESSFULLY DEPLOYED. 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 25410930 ↗
• MalfunctionMar 30, 2026Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 7.0X40MM ARMADA 35 BALLOON DILATATION CATHETER, WHEN NEGATIVE PRESSURE WAS APPLIED, BUBBLES WERE NOTED. THE DEVICE WAS THEN PRESSURIZED AND EXPANDED NORMALLY. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713297 ↗
• MalfunctionFeb 26, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS STENOTIC ILIAC ARTERY. AN UNSPECIFIED GUIDEWIRE CROSSED THE LESION, DILATATION WAS ATTEMPTED WITH THE 7 X 40 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC); HOWEVER, THE LESION WAS TIGHTER THAN EXPECTED AND THE BALLOON RUPTURED AT NOMINAL PRESSURE DURING THE FIRST INFLATION. THE ARMADA 35 BDC WAS WITHDRAWN, AND A NON-ABBOTT DRUG-COATED BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24460408 ↗
• InjuryFeb 19, 2026Difficult to Remove; Material Separation; Stretched; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY (CIA) AND A CHRONIC TOTAL OCCLUSION IN THE LEFT COMMON ILIAC ARTERY WITH HEAVY CALCIFICATION. THE 7MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 10 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A 7X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS USED TO CONTINUE THE PROCEDURE. THE BALLOON WAS INFLATED TO 10 (ATM) FOR 10 SECONDS WITHOUT ISSUE. WHEN RETRACTING THE BALLOON BACK INTO THE INTRODUCER SHEATH, RESISTANCE WAS NOTED AND MODEST FORCE WAS APPLIED. THE RADIOPAQUE MARKER MOVED TOWARDS THE INTRODUCER SLOWLY, WHICH LED TO THE OPERATOR BELIEVING THAT THE BALLOON WAS RETRACTING. HOWEVER, THE BALLOON BECAME ELONGATED AND STRETCHED AND THEN BROKE INTO TWO PIECES. THE ARMADA DEVICE WAS PULLED OUT OF THE PATIENT WITH APPROXIMATELY 4/5THS OF THE BALLOON STILL ATTACHED TO THE DEVICE. THE DISTAL 1/5TH ALONG WITH BOTH RADIOPAQUE MARKERS WERE LEFT INSIDE THE PATIENT, STILL ON THE NON-ABBOTT GUIDE WIRE (GW). SEVERAL ATTEMPTS WERE MADE TO REMOVE THE REMAINING BALLOON PARTS FROM THE PATIENT

  Patient problems: Foreign Body In Patient

  MAUDE report 24393254 ↗
• MalfunctionNov 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREP OF THE 7X40MM ARMADA BALLOON 35 BALLOON WAS INFLATED OUTSIDE OF THE ANATOMY AND NOTED TO HAVE A HOLE AS IT WAS LEAKING. ALSO WHEN PULLED BACK SUCTION ON BALLOON IT KEEP SUCKING AIR. THERE BALLOON WAS USED AND A NEW ARMADA BALLOON WAS USED TO SUCCESSFULLY CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487588 ↗
• MalfunctionAug 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT MILDLY CALCIFIED, MILDLY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY THAT IS 90% STENOSED. THE FIRST 7.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) OVER AN UNSPECIFIED GUIDE WIRE COMPLETELY FAILED TO INFLATE. DURING INFLATION OF A SECOND 7.0X40MM ARMADA 35 BDC, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. A THIRD ARMADA 35 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22884866 ↗
• MalfunctionAug 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT MILDLY CALCIFIED, MILDLY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY THAT IS 90% STENOSED. THE FIRST 7.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) OVER AN UNSPECIFIED GUIDE WIRE COMPLETELY FAILED TO INFLATE. DURING INFLATION OF A SECOND 7.0X40MM ARMADA 35 BDC, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. A THIRD ARMADA 35 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22884860 ↗
• MalfunctionAug 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A RESTENOSIS IN A HEAVILY CALCIFIED, HEAVILY TORTUOUS ARTERIOVENOUS FISTULA LESION, WITH 80% STENOSIS. THE 7MM/40MM ARMADA 35 DILATATION CATHETER (BDC) WAS PREPPED OUTSIDE THE ANATOMY PRIOR TO USE, WITHOUT ANY ISSUES. THE BDC WAS ADVANCED; HOWEVER, A RUPTURE OCCURRED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER ARMADA 35. 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 22728979 ↗
• InjuryJul 14, 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 PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT COMMON FEMORAL ARTERY. THE 7X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE INFLATED; HOWEVER, THE BALLOON WAS NOTED TO RUPTURE UNDER THE RATED BURST PRESSURE. DURING REMOVAL, RESISTANCE WAS FELT WITH THE 6FR SHEATH AND THE BALLOON WAS NOTED TO SEPARATE IN THE ANATOMY. A NON-ABBOTT STENT WAS DEPLOYED TO EMBED THE SEPARATE BALLOON PORTION TO THE VESSEL WALL. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22500619 ↗
• InjuryNov 18, 2024Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 80% STENOSED AND MILDLY TORTUOUS LESION IN THE FISTULA ARTERY. A 7.0X40MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION AND THE BALLOON INFLATED APPROXIMATELY 3 ATMOSPHERES OVER THE RATED BURST PRESSURE (RBP) AND WAS NOTED TO RUPTURE. THE BDC WAS REMOVED HOWEVER PIECES OF THE BALLOON WERE NOTED TO BE SEPARATED AND STUCK ALONG THE SHEATH AND GUIDEWIRE. THE SEPARATED PIECES WERE REMOVED USING A SNARE DEVICE. THE PATIENT WAS NOTED TO LOSS INCREASED AMOUNT OF BLOOD AND THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT BALLOON. THERE WERE REPORTED NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20708005 ↗
• MalfunctionOct 30, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE AV FISTULA WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 7X40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 15 ATMOSPHERES (ATM) AFTER 2 INFLATIONS. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER 7X40MM ARMADA BALLOON WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570725 ↗
• InjuryOct 9, 2024Entrapment of Device; Material Rupture; Difficult to Advance; Entrapment of Device; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE EXTERNAL ILIAC ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 100% STENOSIS. THE 7X40 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH A PREVIOUSLY IMPLANTED STENT. THE BALLOON WAS INFLATED TWICE TO 12 ATMOSPHERES AND RUPTURED. IT WAS ATTEMPTED TO PULL THE DEVICE INTO THE SHEATH BUT THERE WAS EXTREME RESISTANCE AND THE DEVICE WAS STUCK. THE DEVICE WAS ABLE TO BE PULLED TO THE PUNCTURE SITE AND A CUT DOWN WAS PERFORMED TO REMOVE THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408919 ↗
• MalfunctionJul 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN EXTREMELY CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 7.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST DILATATION OF A STENT HOWEVER RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATM). THE BDC WAS REMOVED WITHOUT ISSUE. A SECOND ARMADA 35 OF THE SAME SIZE WAS ADVANCED HOWEVER AGAIN RUPTURED DURING THE FIRST INFLATION AT 11 ATM. THE BDC WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE COMPLETED WITH A NON-ABBOTT DEVICE. 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 19804987 ↗
• MalfunctionJul 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN EXTREMELY CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE 7.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST DILATATION OF A STENT HOWEVER RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATM). THE BDC WAS REMOVED WITHOUT ISSUE. A SECOND ARMADA 35 OF THE SAME SIZE WAS ADVANCED HOWEVER AGAIN RUPTURED DURING THE FIRST INFLATION AT 11 ATM. THE BDC WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE COMPLETED WITH A NON-ABBOTT DEVICE. 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 19804950 ↗
• MalfunctionJul 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ARTERIOVENOUS FISTULA. THE 7X40 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS INFLATED BELOW THE RATED BURST PRESSURE AND RUPTURED. 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 19794545 ↗
• InjuryMar 7, 2024Break; Entrapment of Device; Material Rupture; Break; Entrapment of Device; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ILIAC ARTERY WITH MODERATE CALCIFICATION. DURING INFLATION, THE 7X40 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED AT 12 ATMOSPHERES. WHEN ATTEMPTING TO REMOVE THE DEVICE THROUGH THE INTRODUCER SHEATH, THE BALLOON BROKE INSIDE THE ARTERY AND IT COULD NOT BE REMOVED. OPEN SURGERY WAS PERFORMED AND THE BALLOON WAS REMOVED. THE PATIENT WAS HOSPITALIZED. THERE WERE NO OTHER ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858327 ↗
• MalfunctionDec 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RE-STENOSED LESION IN THE ARTERIOVENOUS (AV) FISTULA OF THE RIGHT ARM WITH 70% STENOSIS, MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 7.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO RESISTANCE DURING ADVANCEMENT. THE BALLOON WAS INFLATED TWICE AT 10 ATMOSPHERES (ATMS) BUT RUPTURED DURING THE SECOND INFLATION. ANOTHER SAME SIZE ARMADA 35 BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 18387812 ↗
• InjuryOct 30, 2023Difficult 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 A FISTULA IN THE CEPHALIC ARCH. PRE-DILATATION WAS PERFORMED WITH A 6MM BALLOON. THE 7.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS NOT PREPARED PER INSTRUCTIONS FOR USE (IFU) AND WAS ADVANCED WITHOUT RESISTANCE, HOWEVER, THE BALLOON BURST DURING THE FIRST INFLATION AT 18 ATMOSPHERES (ATMS). THERE WAS RESISTANCE DURING REMOVAL WITH THE ANATOMY AND FORCE WAS APPLIED THEN SEPARATED IN THE ANATOMY UPON REMOVAL. THE SEPARATED MATERIAL REMAINED ON THE GUIDE WIRE AND WAS SNARED FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELAE 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 18030515 ↗
• MalfunctionSep 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON FEMORAL ARTERY (CFA) WITH MEDIUM TO HEAVY CALCIFICATION. THE 7.0X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AND RUPTURED AT 3 ATMOSPHERES (ATMS). THE BDC WAS REMOVED AND ANOTHER ARMADA 35 BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 17824913 ↗
• MalfunctionSep 8, 2023Material Rupture; Material Rupture

  CORRECTION: THE BALLOON RUPTURE OCCURRED WITH A 7X40MM ARMADA, NOT A 5.0X200MM ARMADA AS INITIALLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17714955 ↗
• MalfunctionSep 6, 2023Difficult to Remove; Material Rupture; Difficult to Advance; Difficult to Remove; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUBCLAVIAN ARTERY. THE 7X40MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND RESISTANCE WAS NOTED WITH A STENT THAT HAD BEEN IMPLANTED IN A PREVIOUS PROCEDURE. THE BALLOON WAS INFLATED TWICE TO NOMINAL PRESSURE AT (6 ATMOSPHERES); HOWEVER, THE BALLOON RUPTURED DURING THE 2ND INFLATION. DURING REMOVAL OF THE BDC IT WAS NOTED THAT THE PROXIMAL END OF THE BALLOON WAS INSIDE SHEATH, BUT THE DISTAL END REMAINED OUT OF THE SHEATH. THEREFORE, THE BDC AND SHEATH HAD TO BE REMOVED AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED WITH A NON-COMPLIANT BALLOON. 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 17695633 ↗
• MalfunctionAug 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). TWO 7MM/40MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WERE USED; HOWEVER, A RUPTURE OCCURRED ABOVE NOMINAL PRESSURE WITH BOTH CATHETERS. ANOTHER NON-ABBOTT BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17483613 ↗
• MalfunctionAug 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). TWO 7MM/40MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WERE USED; HOWEVER, A RUPTURE OCCURRED ABOVE NOMINAL PRESSURE WITH BOTH CATHETERS. ANOTHER NON-ABBOTT BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17483585 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TREATING A TARGET LESION IN THE MID EXTERNAL ILIAC ARTERY. BALLOON ANGIOPLASTY WAS PERFORMED USING THE 7.0 X 40 MM ARMADA 35 DILATATION CATHETER. A DISSECTION OCCURRED AFTER ANGIOPLASTY. A 10.0 X 20 MM ABSOLUTE PRO STENT, WAS IMPLANTED, TREATING BOTH THE TARGET LESION AND THE DISSECTION. THE EVENT RESOLVED ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 16423662 ↗