XXL™ Esophageal M001145550Recalls & 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 08714729163121), received between Aug 20, 2019 and Aug 20, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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
Device problems
- Material Rupture2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. TWO 18-2/5.8/75 XXL ESOPHAGEAL BALLOON CATHETERS AND THREE 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETERS WERE USED FOR DILATATION. HOWEVER, DURING INFLATION AT 3-5 ATMOSPHERES, THESE DEVICES RUPTURED CONSECUTIVELY UPON USING. THEY USED TWO OR MORE BALLOONS TO EXPAND THE STENT SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8912672 ↗MalfunctionAug 20, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. TWO 18-2/5.8/75 XXL ESOPHAGEAL BALLOON CATHETERS AND THREE 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETERS WERE USED FOR DILATATION. HOWEVER, DURING INFLATION AT 3-5 ATMOSPHERES, THESE DEVICES RUPTURED CONSECUTIVELY UPON USING. THEY USED TWO OR MORE BALLOONS TO EXPAND THE STENT SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8912619 ↗
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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