XXL™ Esophageal M001145500Recalls & reported problems
Boston Scientific Corporation · Balloon Dilatation Catheter · Class 2
All models of XXL Esophageal (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729163039), received between Dec 3, 2022 and Jun 18, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2024Leak/Splash; Leak/Splash
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28MAY2024. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIC VENOUS ARTERY. A 16-2/5.8/75 XXL ESOPHAGEAL BALLOON DILATOR WAS SELECTED FOR TREATMENT. THE DEVICE WAS PREPPED AS USUAL AND WAS INSERTED INTO THE BODY. DURING THE PROCEDURE, THE OPERATOR PULLED NEGATIVE ON THE BALLOON AND THE INDIFLATOR WAS FILLED WITH BLOOD. THERE WAS NO ATTEMPT TO INFLATE THE DEVICE. THE DEVICE WAS REMOVED AND REPLACED WITH A NON-BOSTON SCIENTIFIC DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19556757 ↗MalfunctionDec 3, 2022Material Integrity Problem; Material Integrity Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25-NOV-2022. IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE PATIENT PRESENTED WITH MAY-THURNER SYNDROME AND UNDERWENT VENOUS ANGIOPLASTY WITH INTERVENTION. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 16-2/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON KEPT LOSING PRESSURE DESPITE DISCONNECTING AND RECONNECTING THE INDEFLATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15912202 ↗
Other Dilator, esophageal devices
- CRE Fixed Wire M00558380Boston Scientific Corporation · Dilator, esophageal359 reports
- CRE Fixed Wire M00558370Boston Scientific Corporation · Dilator, esophageal219 reports
- XXL™ Esophageal M001145590Boston Scientific Corporation · Dilator, esophageal116 reports
- Olympus BD-400P-2080Gyrus ACMI, LLC · Dilator, esophageal1 recall60 reports
- CRE Wireguided M00558500Boston Scientific Corporation · Dilator, esophageal1 recall58 reports
- Olympus BD-400P-1580Gyrus ACMI, LLC · Dilator, esophageal2 recalls4 reports
- XXL™ Esophageal M001145520Boston Scientific Corporation · Dilator, esophageal102 reports
- EZDilate BD-410X-1055Gyrus ACMI, LLC · Dilator, esophageal2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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