XXL™ Esophageal M001145540Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 08714729163114), received between Sep 18, 2018 and Jun 16, 2025 — classified as 3 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (80 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 16-6/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS UNPACKED AND WAS DILATED WITH A PRESSURE PUMP. IT WAS FOUND THAT THE ANTERIOR SEGMENT OF THE BALLOON WAS LEAKED GAS AND LIQUID. IT WAS ALSO OBSERVED THAT THE BALLOON RUPTURED UPON SECOND INFLATION AT 5 ATMOSPHERES FOR 60 SECONDS. 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 22215932 ↗
• InjuryMar 17, 2025Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON GOT PUNCTURED BY THE OVERLAPPING STENTS AND ADDITIONAL INTERVENTION REQUIRED TO REMOVE THE BALLOON MATERIAL. THE 40% STENOSED TARGET LESION WAS LOCATED IN THE COMMON FEMORAL VEIN. A 16-6/5.8/75 XXL BALLOON CATHETER WAS SELECTED TO POST-DILATE AND PLACE TWO WALLSTENTS FOR VENOUS COMPRESSION. DURING THE PROCEDURE, AT THE OVERLAPPING SEGMENT OF THE TWO STENTS, THE BALLOON CATHETER WAS PUNCTURED. AS THE PHYSICIAN ATTEMPTED TO REMOVE THE DAMAGED BALLOON; HOWEVER, IT BROKE AND BECAME LODGED IN THE COMMON FEMORAL VEIN. DESPITE EFFORTS TO RETRIEVE THE BALLOON PERCUTANEOUSLY, REMOVAL THROUGH THE SHEATH WAS UNSUCCESSFUL. GIVEN THE CIRCUMSTANCES, NO FURTHER MINIMALLY INVASIVE OPTIONS WERE FEASIBLE, NECESSITATING A SURGICAL CUT-DOWN PROCEDURE TO EXTRACT THE FRACTURED BALLOON. THE PROCEDURE WAS SUCCESSFULLY PERFORMED, AND THE INCISION SITE WAS CLOSED WITHOUT COMPLICATIONS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION BUT IS ANTICIPATED TO RECOVER FULLY WITHOUT ANY FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620863 ↗
• MalfunctionSep 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 16-6/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INFLATION AT 4 ATMOSPHERES, THE BALLOON BURST. A BURST IN THE MIDDLE OF THE BALLOON WAS NOTED. THE DEVICE WAS REMOVED INTACT ALONG WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237930 ↗
• MalfunctionAug 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON WAS USED FOR POST-DILATION. HOWEVER, DURING THE FIRST INFLATION AT A NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074198 ↗
• MalfunctionApr 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC VEIN. A 16-6/5.8/75 XXL ESOPHAGEAL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON BURST UPON FIRST INFLATION AT 5 ATMOSPHERES FOR A FEW SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047214 ↗
• MalfunctionApr 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC VEIN. A 16-6/5.8/75 XXL ESOPHAGEAL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON BURST UPON FIRST INFLATION AT 5 ATMOSPHERES FOR FEW SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046918 ↗
• MalfunctionApr 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. THE 79% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC VEIN AND EXTERNAL ILIAC VEIN. DURING THE PROCEDURE, AFTER AN 18X90 WALLSTENT WAS PLACED, A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON WAS PLACED JUST DISTAL OF PROXIMAL END OF THE STENT FOR POST-DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 3 ATMOSPHERES FOR 2 SECONDS, THE BALLOON BURST. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011008 ↗
• MalfunctionMar 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 76% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC VEIN. A 16-6/5.8/75 XXL ESOPHAGEAL WAS ADVANCED FOR DILATATION. DURING FIRST INFLATION AT 5 ATMOSPHERES FOR FEW SECONDS, THE BALLOON WOULD NOT HOLD UP PRESSURE AND BURST. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932486 ↗
• MalfunctionMar 14, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE PATIENT UNDERWENT A VENOGRAM TO BE TREATED FOR MAY THURNERS ON THE BILATERAL COMMON ILIAC VEIN. THE TARGET LESION WAS A COMPRESSION OF 80% STENOSIS, MILDLY TORTUOUS AND A COMPRESSION OF SEVERE CALCIFICATION. BILATERAL 18-90 WALLSTENTS WERE PLACED, AND POST DILATATION WAS DONE WITH TWO 6/5.8/75 XXL BALLOON CATHETERS. BOTH BALLOONS INFLATED AT 5 ATMOSPHERES UNTIL IT WAS NOTED THAT ONE OF THE BALLOONS WOULD NOT HOLD PRESSURE. UPON REMOVING, A SMALL HOLE WAS IDENTIFIED. THE DEVICE WAS REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18906172 ↗
• MalfunctionFeb 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. A: 16-6/5.8/75 XXL ESOPHAGEAL BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667738 ↗
• MalfunctionFeb 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667672 ↗
• MalfunctionDec 18, 2023Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29NOV2023. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE CONTRAST AGENT WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT A LONGITUDINAL TEAR WAS IDENTIFIED IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18350321 ↗
• MalfunctionNov 20, 2023Contamination; Contamination

  IT WAS REPORTED THAT PACKAGE CONTAMINATION OCCURRED. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS SELECTED AND UNPACKED. HOWEVER, UPON OPENING, THE TECHNICIAN CONTAMINATED THE DEVICE BY TOUCHING WITH HER HAND BEFORE DROPPING ON STERILE TABLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172318 ↗
• MalfunctionNov 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 16-6/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166186 ↗
• MalfunctionNov 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST. THE DEVICE WAS REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102813 ↗
• MalfunctionJun 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED ILIAC VEIN. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 3 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED EVEN BEFORE IT REACHED THE NOMINAL PRESSURE. THE DEVICE WAS PULLED BACK EASILY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231562 ↗
• MalfunctionDec 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 87% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED TO DILATE A PREVIOUSLY PLACED VENOUS STENT. HOWEVER, ON THE FIRST INFLATION AT 5 ATMOSPHERES FOR FEW SECONDS, THE BALLOON RUPTURED. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND THE DEVICE WAS REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949099 ↗
• MalfunctionOct 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED COMMON ILIAC ARTERY. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON DILATOR WAS ADVANCED FOR POST DILATATION OF A PREVIOUSLY PLACED STENT. HOWEVER, DURING INITIAL INFLATION AT 4 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 16-6/5.8/75 XXL ESOPHAGEAL BALLOON DILATOR. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AT 2 ATMOSPHERES FOR LESS THAN 15 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611297 ↗
• MalfunctionAug 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VEIN AT THE LOWER EXTREMITY. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15183645 ↗
• MalfunctionMay 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 78% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ILIAC VEIN. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON DILATOR WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 4 ATMOSPHERES FOR 5-10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT FULLY INTACT AND THE PROCEDURE WAS COMPLETED WITH A SECOND 16X6 XXL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14365272 ↗
• MalfunctionFeb 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TO MODERATELY TORTUOUS ILIAC VEIN. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FOURTH INFLATION AT 4 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED FULLY INTACT AND COMPLETED THE PROCEDURE WITH A 16X6 XXL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518628 ↗
• MalfunctionFeb 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 58% STENOSED TARGET LESION WAS LOCATED IN THE MILD TO MODERATELY TORTUOUS ILIAC VEIN. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FOURTH INFLATION AT 5 ATMOSPHERES FOR 5-10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 16X6 XXL BALLOON CATHETER. THERE WERE NO COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13500405 ↗
• MalfunctionJan 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TO MODERATELY TORTUOUS RIGHT ILIAC VEIN. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 2 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A 18X6X75 BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314260 ↗
• MalfunctionJan 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 68% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TO MODERATELY TORTUOUS RIGHT COMMON AND EXTERNAL ILIAC ARTERY. AN 16-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 5 ATMOSPHERES FOR 15-20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 16X6X75 XXL ESOPHAGEAL BALLOON CATHETER. THERE WERE NO COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13203433 ↗
• MalfunctionOct 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILD TO MODERATELY TORTUOUS RIGHT ILIAC VEIN. A 16-6/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED TO PRE-DILATE THE VESSEL. THE BALLOON WAS INFLATED IN THREE DIFFERENT AREAS AT 5 ATMOSPHERES (ATM) AND A WALLSTENT WAS SUCCESSFULLY DEPLOYED. THE SAME BALLOON WAS INSERTED TO POST DILATE THE STENT TO GET BETTER WALL APPOSITION; HOWEVER, ON THE FOURTH INFLATION AT 4 ATM FOR 10 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS FULLY DEFLATED AND REMOVED FROM THE PATIENT FULLY INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697083 ↗