XXL EsophagealRecalls & reported problems across all models
Boston Scientific Corporation · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 406
- Deaths reported
- 1
- Injuries reported
- 20
- Recalls
- 0
We found 10 models of XXL Esophageal by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 406 adverse event reports in the FDA's MAUDE database, received between Aug 18, 2017 and May 27, 2026 — classified as 1 death, 20 injuries, 385 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (370 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported XXL Esophageal problems
Device problems
- Material Rupture370
- Detachment of Device or Device Component19
- Difficult to Remove14
- Leak/Splash13
- Break12
- Deflation Problem6
- Adverse Event Without Identified Device or Use Problem4
- Device-Device Incompatibility4
Patient problems
- No Consequences Or Impact To Patient224
- No Clinical Signs, Symptoms or Conditions160
- No Known Impact Or Consequence To Patient19
- Device Embedded In Tissue or Plaque4
- Foreign Body In Patient3
- Chest Pain1
- Embolism/Embolus1
- Insufficient Information1
XXL Esophageal models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- XXL™ Esophageal M001145590Dilator, esophageal116 reports
- XXL™ Esophageal M001145520Dilator, esophageal102 reports
- XXL™ Esophageal M001145570Dilator, esophageal87 reports
- XXL™ Esophageal M001145540Dilator, esophageal82 reports
- XXL™ Esophageal M001145580Dilator, esophageal7 reports
- XXL™ Esophageal M001145530Dilator, esophageal1 death6 reports
- XXL™ Esophageal M001145500Dilator, esophageal2 reports
- XXL™ Esophageal M001145550Dilator, esophageal2 reports
- XXL™ Esophageal M001145510Dilator, esophageal1 report
- XXL™ Esophageal M001145560Dilator, esophageal1 report
Recent XXL Esophageal adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Incomplete or Missing Packaging
IT WAS REPORTED THAT LABELLING ISSUE OCCURRED. AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS SELECTED FOR USE. DURING INSPECTION, IT WAS NOTED THAT THE BACK OF THE PACKAGING WAS LABELED "NON-STERILE." THE DEVICE WAS NOT USED, AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301323 ↗MalfunctionMay 27, 2026Incomplete or Missing Packaging
IT WAS REPORTED THAT LABELLING ISSUE OCCURRED. AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS RECEIVED IN THE HOSPITAL. UPON RECEIPT OF THE DEVICE, IT WAS NOTED THAT THE BACK OF PACKAGING SAYS "NON-STERILE". THE DEVICE WAS NOT USED IN A PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25300415 ↗MalfunctionMay 26, 2026Incomplete or Missing Packaging
IT WAS REPORTED THAT LABELLING ISSUE OCCURRED. AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS RECEIVED IN THE HOSPITAL. UPON RECEIPT OF THE DEVICE, IT WAS NOTED THAT THE BACK OF PACKAGING SAYS "NON-STERILE". THE DEVICE WAS NOT USED IN A PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25294385 ↗MalfunctionApr 15, 2026Fluid/Blood Leak; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. AN XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT 2 ATMOSPHERES, THE BALLOON LEAK AND WOULD NOT GO ABOVE 2 ATMOSPHERES AND DID NOT REACH THE REQUIRED PRESSURE. IT WAS DETERMINED THAT THE BALLOON RUPTURED. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885649 ↗MalfunctionFeb 20, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 18-6/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 5 ATMOSPHERES. 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 24405203 ↗MalfunctionFeb 20, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 18-6/5.8/75 XXL BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 5 ATMOSPHERES. 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 24405043 ↗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 ↗MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED VIA MEDWATCH MW5178958 THAT BALLOON DETACHMENT OCCURRED. AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON CATHETER DETACHED FROM THE CATHETER SHAFT DURING REMOVAL FROM THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23864539 ↗InjuryDec 5, 2025Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING A CUT DOWN FOR REMOVAL. THE 50-60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS EXTERNAL ILIAC VEIN. AN XXL/18-4/5.8/75 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER SHAFT BROKE OFF INSIDE THE PATIENT, REQUIRING A CUT DOWN TO REMOVE THE BROKEN PIECE. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.
Patient problems: Embolism/Embolus
MAUDE report 23733001 ↗InjuryOct 23, 2025Break; Difficult to Remove; Break; Difficult to Remove
IT WAS REPORTED THAT BALLOON CAME OFF THE SHAFT UPON REMOVAL, STUCK IN THE VEIN AND SURGICAL CUT WAS MADE TO REMOVE THE BALLOON. THE 70-90% STENOSED AND COMPRESSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED, SO FIBROUS AND SOME WEBBING PREVIOUS DEEP VEIN THROMBOSIS (DVT). AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR POST DILATION AFTER PLACEMENT OF AN 22X70 WALL STENT WAS PLACED ON THE LEFT SIDE. UPON REMOVAL, IT WAS NOTED THAT THE BALLOON CAME OFF THE SHAFT AND BECAME STUCK IN THE EXTERNAL ILIAC VEIN. A SURGICAL CUT DOWN TO THE LEFT COMMON FEMORAL VEIN AND INCISION MADE TO THE VEIN TO REMOVE THE BALLOON AFTER IT WAS SNARED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. PATIENT WENT HOME THE NEXT DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23371097 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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