Armada B1070-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08717648154799), received between May 3, 2017 and Sep 29, 2026 — classified as 9 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (27 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938796 ↗
• MalfunctionJun 11, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT VEIN GRAFT FOR A FISTULA GRAM. THE 7X60MM ARMADA 35 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 DURING THE INITIAL INFLATION AT 15 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. 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 25480800 ↗
• MalfunctionJun 10, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT BASILIC VEIN FISTULA WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 7X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION AT 11 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON WAS USED TO CONTINUE 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 25462327 ↗
• MalfunctionJan 23, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A, HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY THAT IS 95% STENOSED. ONCE AT THE LESION, A LEAK WAS NOTED AT 6 ATMOSPHERES ON THE ARMADA 35 BALLOON DILATATION CATHETER DURING THE FIRST INFLATION. A LEAK WAS ALSO NOTED AT 6 ATMOSPHERES ON THE7.0X60MM ARMADA 35 BDC DURING THE SECOND INFLATION. 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 24167369 ↗
• MalfunctionJan 7, 2026Inflation Problem; Leak/Splash; Material Split, Cut or Torn

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 7X60MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. HOWEVER, THE BALLOON FAILED TO INFLATE. THEREFORE, A LEAK OR HOLE IN THE BALLOON WAS SUSPECTED, BUT NOT OBSERVED AS INITIALLY REPORTED. THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996881 ↗
• InjuryJan 5, 2026Entrapment of Device; Material Rupture; Material Separation

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT AV FISTULA. AN ARMADA 35 7MM/60MM WAS INSERTED AND ADVANCED TO THE TARGET LESION. HOWEVER, UPON THE FIRST INFLATION, A BALLOON RUPTURE OCCURRED AT 13ATM. PART OF THE BALLOON AND BALLOON MARKERS CAME OFF AND WRAPPED AROUND THE NON-ABBOTT GUIDE WIRE THAT AS INSIDE THE PATIENT. THE DEVICES WERE UNABLE TO BE REMOVED, AND THE PHYSICIAN CUT PARTS OF THE WIRE THAT WAS EXPOSED, AND THE PATIENT WAS SENT INTO SURGERY TO HAVE IT REMOVED. ALL PARTS OF THE OF THE DEVICE WAS SUCCESSFULLY REMOVED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961839 ↗
• MalfunctionJan 2, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT AV GRAFT WITH SEVERE CALCIFICATION. THE 7X60 MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 13 ATMOSPHERES. THERE WERE NO ADVERSE PATIENT EFFECTS, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946202 ↗
• MalfunctionNov 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE ILIAC ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 7X60MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERE (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. 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 23609311 ↗
• InjuryAug 27, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AV FISTULA ARTERY. THE 7X60MM ARMADA BALLOON DILATION CATHETER (BDC) WAS USED IN THE PROCEDURE; HOWEVER, DURING REMOVAL RESISTANCE WAS NOTED WITH AN UNSPECIFIED GUIDE WIRE AND THE TIP OF THE BDC BROKE OFF AND REMAINED IN THE AV FISTULA. ATTEMPTS WERE MADE TO REMOVED THE SEPARATED PORTION PERCUTANEOUSLY BUT WERE UNSUCCESSFUL. THEREFORE, CUTDOWN SURGERY WAS PERFORMED TO RETRIEVE THE TIP OF THE BDC. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910190 ↗
• MalfunctionMay 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT MILD TO MODERATE CALCIFIED RIGHT ARTERIOVENOUS GRAFT. A 7X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED, BUT THE BALLOON RUPTURED AT 14 ATMOSPHERES, DURING THE FIRST INFLATION. A NON-ABBOTT, NON-COMPLIANT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013795 ↗
• InjuryDec 22, 2024Difficult 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 THE PROXIMAL SUPERFICIAL FEMORAL ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 7X60MM ARMADA 35 BALLOON PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER WHICH WAS PREPARED PER INSTRUCTIONS FOR USE, WAS ADVANCED AND THE BALLOON WAS INFLATED ONCE TO BELOW RATED BURST PRESSURE. AFTER 2 MINUTES OF INFLATION, THE PRESSURE DROPPED AND A RUPTURE WAS NOTED. UPON WITHDRAWAL OF THE DILATATION CATHETER, RESISTANCE WAS NOTED AND FORCE WAS APPLIED. THE BALLOON SEPARATED AND ONLY THE PROXIMAL PORTION WAS WITHDRAWN. THE UNSPECIFIED 6FR INTRODUCER SHEATH WAS EXCHANGED FOR A LARGER UNSPECIFIED 8FR SHEATH, AND AN UNSUCCESSFUL ATTEMPT WAS MADE TO SNARE THE DISTAL PORTION. A SURGICAL CUT DOWN PROCEDURE WAS PERFORMED AND THE DISTAL PORTION WAS SUCCESSFULLY RETRIEVED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20997542 ↗
• InjuryAug 21, 2024Difficult 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 TO TREAT MODERATELY CALCIFIED LEFT COMMON ILIAC ARTERY. THE 7.0X60MM ARMADA 35 BALLOON CATHETER WAS ADVANCED WITH A 7FR SHEATH; HOWEVER, RESISTANCE WAS FELT DURING ADVANCEMENT WITH ANATOMY. ONCE AT THE LESION, THE BALLOON WAS INFLATED AND RUPTURED AT 4 ATMOSPHERES DURING THE FIRST INFLATION. DURING REMOVAL RESISTANCE WAS FELT WITH ANATOMY WHILE WITHDRAWING INTO THE SHEATH AND THE DISTAL TIP SEPARATED. THE SEPARATED TIP WAS REMOVED VIA SNARE. AN UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011925 ↗
• MalfunctionNov 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION. THE 7X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS BEING USED; HOWEVER, A RUPTURE OCCURRED AT THE FIRST INFLATION AT 15 ATMOSPHERES AND REMOVED INDEPENDENTLY. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222915 ↗
• MalfunctionSep 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN ARTERIOVENOUS (AV) GRAFT OF THE LEFT ARM WITH MILD CALCIFICATION AND NO TORTUOSITY. THE 7.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND WAS ADVANCED WITHOUT RESISTANCE, HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATMS). ANOTHER NON-ABBOTT BALLOON COMPLETED 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 17835087 ↗
• MalfunctionSep 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ARTERIOVENOUS GRAFT OF THE LEFT ARM. THE 7.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT BUT RUPTURED AT 14 ATMOSPHERES (ATMS) DURING THE FIRST INFLATION. THERE WAS NO RESISTANCE DURING REMOVAL. THE DEVICE WAS SOAKED AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. ANOTHER SAME SIZED ARMADA 35 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 15473322 ↗
• InjurySep 23, 2022Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MID LEFT ILIAC ARTERY WITH 80% STENOSIS, HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 7.0X60MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT, HOWEVER, BURST DURING THE FIRST INFLATION AT 4 ATMOSPHERES (ATMS) IN A CIRCULAR FORM. THE ARMADA 35 BDC WAS SOAKED AND PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THERE WAS RESISTANCE DURING REMOVAL WHEN TRYING TO WITHDRAW THE DELIVERY SYSTEM OF THE BALLOON AS A UNIT. UPON REMOVAL, THE BALLOON AND DELIVERY CATHETER WERE NOTED TO BE SEPARATED AND SURGICAL ARTERIOTOMY WAS PERFORMED TO REMOVE THE PROXIMAL PART OF THE BALLOON AND DELIVERY CATHETER. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS A DELAY OF 1 HOUR IN THE PROCEDURE DUE TO THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15473203 ↗
• MalfunctionAug 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 80% STENOSED DE NOVO LESION IN THE RIGHT EXTERNAL ILIAC ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. USING ACCESS FROM THE RIGHT COMMON FEMORAL ARTERY, THE 7X60MM ARMADA BALLOON DILATATION CATHETER (BDC) WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE AND ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE, THEN INFLATED ONE TIME TO 15 ATMOSPHERES(ATM) FOR 15 SECONDS; HOWEVER, A RUPTURED OCCURRED. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER ARMADA BALLOON FOLLOWED BY DEPLOYMENT OF AN OMNILINK STENT WERE USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272353 ↗
• MalfunctionJul 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT THE LEFT POSTERIOR TIBIAL ARTERY WITH MODERATE STENOSIS. AN ARMADA 35 7MM/60MM WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE; HOWEVER, ON THE FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136580 ↗
• InjuryApr 25, 2022Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED ARTERY. THE 7.0X60MM ARMADA 35 BALLOON CATHETER RUPTURED ON THE LAST INFLATION. UPON ATTEMPTED REMOVAL, IT WAS NOTED TO BE VERY DIFFICULT TO REMOVE OVER THE GUIDE WIRE AND WHEN IT REACHED THE SHEATH IT WOULDN'T GO THROUGH THE SHEATH. THE WHOLE SYSTEM WAS PULLED OUT AND IT WAS FOUND THAT THE SOME OF THE INNER CATHETER OF THE BALLOON WAS STILL STICKING OUT OF THE PATIENT. THE INNER CATHETER WAS REMOVED AND IT WAS VERIFIED THAT ALL PIECES OF THE BALLOON WERE REMOVED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196380 ↗
• MalfunctionApr 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 7X60MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED. 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 11745249 ↗
• InjuryJan 10, 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 MODERATELY CALCIFIED, 70% STENOSED LEFT ARTERIOVENOUS FISTULA. A 7X60MM ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED AT 15 ATMOSPHERES, AND RESISTANCE WAS FELT WITH THE ANATOMY DURING WITHDRAWAL. FORCE WAS APPLIED, AND THE BALLOON SEPARATED INTO TWO PIECES. A SNARE WAS USED TO REMOVED THE SEPARATED PORTION, AND AN UNSPECIFIED BALLOON WAS USED TO 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: No Consequences Or Impact To Patient

  MAUDE report 11144313 ↗
• MalfunctionDec 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A HIGHLY STENOSIS AXILLARY VEIN. AN ARMADA 35 7X60 BALLOON CATHETER WAS INSERTED AND ATTEMPTED TO BE INFLATED. HOWEVER, DURING INFLATION THE BALLOON RUPTURED AT 12 ATMOSPHERES. THE BALLOON WAS ABLE TO BE REMOVED WITHOUT ISSUES. 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 11065164 ↗
• MalfunctionDec 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT HIGH GRADE STENOSIS IN THE LEFT BRACHIAL. AN ARMADA 35 BALLOON CATHETER WAS INSERTED, AND ANGIOPLASTY WAS PERFORMED. WHILE ATTEMPTING TO RESOLVE THE STENOSIS, THE BALLOON RUPTURED AT AN UNKNOWN ATMOSPHERE. THE BALLOON CATHETER WAS ABLE TO BE REMOVED WITHOUT ISSUES AND A NON-ABBOTT DEVICE WAS USED TO TREAT THE STENOSIS. 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 11039780 ↗
• InjuryJun 4, 2020Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118526 ↗
• MalfunctionMay 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED ARTERY. A 7X60MM ARMADA 35 BALLOON DILATATION CATHETER RUPTURED AT 12 ATMOSPHERES WHEN INFLATED. 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 10075385 ↗