XXL™ Esophageal M001145520Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 08714729163060), received between Aug 18, 2017 and Dec 22, 2025 — classified as 9 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (97 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. FOUR 16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETERS WERE ADVANCED FOR DILATATION. DURING THE PROCEDURE, ALL FOUR BALLOONS RUPTURED AT LOW INFLATION PRESSURES. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A 14 MM XXL BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 70% STENOSED TARGET LESION WAS LOCATED IN NON-TORTUOUS AND NON-CALCIFIED BILATERAL ILIAC VEINS. DURING THE SECOND INFLATION AT OR BELOW NOMINAL PRESSURE, THE BALLOON RUPTURED. IT WAS DETERMINED THAT PATIENT ANATOMY DID NOT CONTRIBUTE TO THE REPORTED EVENT. ADDITIONALLY, PATIENT FACTORS AND PROCEDURAL FACTORS WERE NOT FOUND TO HAVE CONTRIBUTED TO THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868098 ↗
• MalfunctionDec 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. FOUR 16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETERS WERE ADVANCED FOR DILATATION. DURING THE PROCEDURE, ALL FOUR BALLOONS RUPTURED AT LOW INFLATION PRESSURES. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A 14 MM XXL BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 70% STENOSED TARGET LESION WAS LOCATED IN NON-TORTUOUS AND NON-CALCIFIED BILATERAL ILIAC VEINS. DURING THE SECOND INFLATION AT OR BELOW NOMINAL PRESSURE, THE BALLOON RUPTURED. IT WAS DETERMINED THAT PATIENT ANATOMY DID NOT CONTRIBUTE TO THE REPORTED EVENT. ADDITIONALLY, PATIENT FACTORS AND PROCEDURAL FACTORS WERE NOT FOUND TO HAVE CONTRIBUTED TO THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868083 ↗
• MalfunctionDec 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. FOUR 16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETERS WERE ADVANCED FOR DILATATION. DURING THE PROCEDURE, ALL FOUR BALLOONS RUPTURED AT LOW INFLATION PRESSURES. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A 14 MM XXL BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868073 ↗
• MalfunctionDec 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT LOW INFLATION PRESSURES. THE PROCEDURE WAS COMPLETED WITH A 14 MM XXL BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 70% STENOSED TARGET LESION WAS LOCATED IN NON-TORTUOUS AND NON-CALCIFIED BILATERAL ILIAC VEINS. DURING THE SECOND INFLATION AT OR BELOW NOMINAL PRESSURE, THE BALLOON RUPTURED. IT WAS DETERMINED THAT PATIENT ANATOMY DID NOT CONTRIBUTE TO THE REPORTED EVENT. ADDITIONALLY, PATIENT FACTORS AND PROCEDURAL FACTORS WERE NOT FOUND TO HAVE CONTRIBUTED TO THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868066 ↗
• MalfunctionAug 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LIVER. A 16-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON THIRD INFLATION AT 6 ATMOSPHERES FOR 10-15 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716987 ↗
• MalfunctionJul 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL. A 16-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 3 ATMOSPHERES FOR APPROXIMATELY 10 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553131 ↗
• MalfunctionJul 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL. A 16-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 4 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553130 ↗
• MalfunctionMar 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT WAS BEING TREATED FOR MAY THURNER SYNDROME. THE 70% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED VEIN. A 16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS USED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 5 ATMOSPHERES FOR LESS THAN 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NEW 16X40 XXL BALLOON. THERE WE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733174 ↗
• MalfunctionJan 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 16-4/5.8/75 XXL ESOPHAGEAL BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST BEFORE IT WAS INFLATED TO THE NOMINAL BURST PRESSURE (NBP). THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144653 ↗
• InjuryOct 28, 2024Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. A NON-BOSTON SCIENTIFIC STENT WAS PLACED FROM A PRIOR PROCEDURE AND INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO DETERMINE THE DISTAL END OF THE STENT NEEDED TO BE BALLOONED. A 16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION FOR 1 MINUTE, THE BALLOON RUPTURED FROM A STENT STRUT. RESISTANCE WAS FELT WHEN THE BALLOON WAS BEING REMOVED. X-RAY CONFIRMED THAT THE RESISTANCE WAS COMING FROM THE BALLOON BEING CAUGHT ON A STENT STRUT ON THE PROXIMAL END OF THE STENT. A SMALL PORTION OF THE STENT WAS FRACTURED AND CAUGHT IN THE BALLOON. THE STENT STRUT WAS ATTEMPTED TO BE RELEASED FROM THE BALLOON BUT WERE UNSUCCESSFUL. THE SHEATH ADVANCED TO TRY TO FREE THE STENT FROM THE BALLOON, HOWEVER, PART OF THE BALLOON DETACHED FROM THE SHAFT OF THE BALLOON CATHETER AND WAS LEFT IN THE GREAT SAPHENOUS VEIN (GSV), ALONGSIDE WITH THE FRACTURED STENT. ACCESS INTO THE FEMORAL VEIN WAS ACHIEVED AND A NEW STENT WAS PLACED TO JAILING OFF THE GSV VEIN TO PREVENT MIGRATION OF THE FRACTURED BALL

  Patient problems: Foreign Body In Patient

  MAUDE report 20547234 ↗
• MalfunctionApr 12, 2024Leak/Splash; Failure to Advance; Device-Device Incompatibility; Leak/Splash; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE PATIENT PRESENTED WITH CANCER COMPRESSION OF THE LEFT COMMON ILIAC ARTERY BY A LYMPH NODE. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY AND INTRAVASCULAR ULTRASOUND (IVUS) REVEALED ALMOST 100% COMPRESSION AND STENOSIS, SEVERE CALCIFICATION, AND MODERATE TORTUOSITY. FOLLOWING PRE-DILATATION WITH A 14X4 XXL BALLOON CATHETER, A WALLSTENT WAS PLACED FROM BIFURCATION THROUGH COMMON ILIAC ARTERY. AFTER DEPLOYMENT, IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT HAD A SMALL ENTRY DIAMETER. A 16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION; HOWEVER, THE BALLOON GOT SLIGHTLY CAUGHT ON THE STENT STRUT AND, UPON NEGATIVE PRESSURE, BLOOD CAME BACK TO THE INDEFLATOR. THE BALLOON WAS REMOVED FULLY INTACT, AND THE SHEATH WAS ADVANCED INTO THE DISTAL END OF THE STENT BEFORE ADVANCING ANOTHER 16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19100332 ↗
• MalfunctionJan 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE ON THE BALLOON OCCURRED. A 16-4/5.8/75 XXL BALLOON DILATOR WAS SELECTED FOR TREATMENT FOR MAY THURNER. ABOVE 80 COMPRESSION WAS NOTED IN THE COMMON ILIAC VEIN AND AN 18X90 WALLSTENT DEVICE WAS PLACED. WHEN THE BALLOON WAS INSERTED, THERE WAS NEGATIVE PRESSURE PULLED WITH THE INDEFLATOR AND BLOOD WAS COMING BACK TO IT. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466324 ↗
• MalfunctionJan 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS ABOVE 70% COMPRESSION ON THE INFERIOR VENA CAVA AND COMMON ILIAC VEIN, AND WAS MILDLY TORTUOUS AND SEVERELY CALCIFIED. BILATERAL 18X90 WALLSTENTS WERE PLACED. A 16-4/5.8/75 XXL BALLOON DILATOR WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 5 ATMOSPHERES FOR A SECOND, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT LEAVING ANY FRAGMENTS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444998 ↗
• MalfunctionJan 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL COMMON ILIAC VEIN. A 16-4/5.8/75 XXL BALLOON DILATOR WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 5 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444982 ↗
• MalfunctionOct 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH MAY THURNER SYNDROME AND UNDERWENT VENOGRAM. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC VEIN (CIV) AND EXTERNAL ILIAC VEIN (EIV). FOLLOWING BILATERAL PLACEMENT OF WALLSTENTS, TWO 16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETERS WERE PLACED BILATERALLY AT THE PROXIMAL CIV FOR KISSING BALLOON INFLATION AT 5 ATMOSPHERES (ATM). THE BALLOONS WERE MOVED BILATERALLY TO MID TO DISTAL (CIV). HOWEVER, DURING THE SECOND INFLATION AT 5 ATM FOR A FEW SECONDS, ONE OF THE BALLOONS RUPTURED. THE BALLOON WAS REPLACED WITH ANOTHER OF SAME DEVICE AND INFLATION WAS COMPLETED THROUGH TO DISTAL EIV. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916872 ↗
• MalfunctionSep 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. PATIENT PRESENTED AND BEING TREATED MAY-THURNER'S SYNDROME. THE 69% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED BILATERAL COMMON ILIAC ARTERY AND RIGHT EXTERNAL ILIAC ARTERY. TWO 16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WERE ADVANCED FOR KISSING BALLOON INFLATION. HOWEVER, DURING INITIAL INFLATION OF THE FIRST 16-4/5.8/75 XXL BALLOON CATHETER, IT WOULD NOT INFLATE RIGHT OFF FROM THE START. THE DEVICE WAS REMOVED, AND A PINHOLE WAS NOTED ON THE BALLOON. SUBSEQUENTLY, ANOTHER 16-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED, BUT DURING THE FIRST INFLATION AT 5 ATMOSPHERES FOR 5 SECONDS, THE BALLOON BURST WITH BLOOD NOTED RETURNED IN THE INDEFLATOR. THE DEVICE WAS ALSO REMOVED, AND ANOTHER OF THE SAME BALLOON CATHETER WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17680431 ↗
• MalfunctionAug 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. PATIENT PRESENTED AND BEING TREATED MAY-THURNER'S SYNDROME. THE 69% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED BILATERAL COMMON ILIAC ARTERY AND RIGHT EXTERNAL ILIAC ARTERY. TWO 16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WERE ADVANCED FOR KISSING BALLOON INFLATION. HOWEVER, FIRST 16-4/5.8/75 XXL BALLOON CATHETER WOULD NOT INFLATE RIGHT OFF FROM THE START. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 16-4/5.8/75 XXL BALLOON CATHETER, BUT DURING THE FIRST INFLATION AT 5 ATMOSPHERES, THE BALLOON BURST WITH BLOOD NOTED RETURNED IN THE INDEFLATOR. THE DEVICE WAS ALSO REMOVED, AND ANOTHER OF THE SAME BALLOON CATHETER WAS USED AND THE PROCEDURE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17562772 ↗
• MalfunctionJun 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN EXTERNAL VEIN. A 16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 5 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17173419 ↗
• MalfunctionJun 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH MAY THURNER SYNDROME. THE 57% STENOSED, LARGE DIAMETER WITH SOME ANGULATION TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND MILDLY TORTUOUS EXTERNAL ILIAC VEIN. DURING A VENOUS STENT CASE, FIVE XXL VASCULAR BALLOON CATHETERS WERE USED OFF LABEL FOR POST-DILATATION OF AN IMPLANTED VENOUS WALLSTENT. FOUR OF WHICH WERE 16-4/5.8/75 AND ONE 14-4/5.8/75 XXL BALLOON CATHETER. HOWEVER, THE FIRST THREE 16-4/5.8/75 XXL VASCULAR BALLOON CATHETERS WERE RUPTURED BY THE DISTAL STENT EDGE BEFORE ANY INFLATIONS WERE PERFORMED. ANOTHER 16-4/5.8/75 AND 14-4/5.8/75 XXL BALLOON CATHETERS WERE USED AND RUPTURED AT 5 ATMOSPHERES DURING THE INITIAL INFLATION. THE DEVICES WERE REMOVED AND COMPLETED THE PROCEDURE WITH A SOFTER WIRE AND ANOTHER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132399 ↗
• MalfunctionJun 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH MAY THURNER SYNDROME. THE 57% STENOSED, LARGE DIAMETER WITH SOME ANGULATION TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND MILDLY TORTUOUS EXTERNAL ILIAC VEIN. DURING A VENOUS STENT CASE, FIVE XXL VASCULAR BALLOON CATHETERS WERE USED OFF LABEL FOR POST-DILATATION OF AN IMPLANTED VENOUS WALLSTENT. FOUR OF WHICH WERE 16-4/5.8/75 AND ONE 14-4/5.8/75 XXL BALLOON CATHETER. HOWEVER, THE FIRST THREE 16-4/5.8/75 XXL VASCULAR BALLOON CATHETERS WERE RUPTURED BY THE DISTAL STENT EDGE BEFORE ANY INFLATIONS WERE PERFORMED. ANOTHER 16-4/5.8/75 AND 14-4/5.8/75 XXL BALLOON CATHETERS WERE USED AND RUPTURED AT 5 ATMOSPHERES DURING THE INITIAL INFLATION. THE DEVICES WERE REMOVED AND COMPLETED THE PROCEDURE WITH A SOFTER WIRE AND ANOTHER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132398 ↗
• MalfunctionJun 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH MAY THURNER SYNDROME. THE 57% STENOSED, LARGE DIAMETER WITH SOME ANGULATION TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND MILDLY TORTUOUS EXTERNAL ILIAC VEIN. DURING A VENOUS STENT CASE, FIVE XXL VASCULAR BALLOON CATHETERS WERE USED OFF LABEL FOR POST-DILATATION OF AN IMPLANTED VENOUS WALLSTENT. FOUR OF WHICH WERE 16-4/5.8/75 AND ONE 14-4/5.8/75 XXL BALLOON CATHETER. HOWEVER, THE FIRST THREE 16-4/5.8/75 XXL VASCULAR BALLOON CATHETERS WERE RUPTURED BY THE DISTAL STENT EDGE BEFORE ANY INFLATIONS WERE PERFORMED. ANOTHER 16-4/5.8/75 AND 14-4/5.8/75 XXL BALLOON CATHETERS WERE USED AND RUPTURED AT 5 ATMOSPHERES DURING THE INITIAL INFLATION. THE DEVICES WERE REMOVED AND COMPLETED THE PROCEDURE WITH A SOFTER WIRE AND ANOTHER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125661 ↗
• MalfunctionJun 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH MAY THURNER SYNDROME. THE 57% STENOSED, LARGE DIAMETER WITH SOME ANGULATION TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND MILDLY TORTUOUS EXTERNAL ILIAC VEIN. DURING A VENOUS STENT CASE, FIVE XXL VASCULAR BALLOON CATHETERS WERE USED OFF LABEL FOR POST-DILATATION OF AN IMPLANTED VENOUS WALLSTENT. FOUR OF WHICH WERE 16-4/5.8/75 AND ONE 14-4/5.8/75 XXL BALLOON CATHETER. HOWEVER, THE FIRST THREE 16-4/5.8/75 XXL VASCULAR BALLOON CATHETERS WERE RUPTURED BY THE DISTAL STENT EDGE BEFORE ANY INFLATIONS WERE PERFORMED. ANOTHER 16-4/5.8/75 AND 14-4/5.8/75 XXL BALLOON CATHETERS WERE USED AND RUPTURED AT 5 ATMOSPHERES DURING THE INITIAL INFLATION. THE DEVICES WERE REMOVED AND COMPLETED THE PROCEDURE WITH A SOFTER WIRE AND ANOTHER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125658 ↗
• MalfunctionMay 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN ILIAC VEIN. TWO 16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETERS WERE ADVANCED FOR POST-DILATATION. HOWEVER, DURING INITIAL INFLATION AT 5 ATMOSPHERES FOR 10 SECONDS, BOTH BALLOONS WERE RUPTURED. THE DEVICES WERE COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007684 ↗
• MalfunctionMay 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN ILIAC VEIN. TWO 16-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETERS WERE ADVANCED FOR POST-DILATATION. HOWEVER, DURING INITIAL INFLATION AT 5 ATMOSPHERES FOR 10 SECONDS, BOTH BALLOONS WERE RUPTURED. THE DEVICES WERE COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16996953 ↗
• MalfunctionMay 16, 2023Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE >50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED ILIAC ARTERY. A 16-4/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON BROKE WHILE INFLATING INSIDE A WALLSTENT. THE BALLOON WAS PULLED OUT THROUGH THE SHEATH AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED WHILE INFLATING, AND THE SHAFT DID NOT BREAK AS PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942920 ↗