RIGIFLEX II M00554520Recalls & reported problems
Boston Scientific Corporation · Single Use Achalasia Ballon Dilator · Class 2
All models of RIGIFLEX II (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729719120), received between Apr 25, 2022 and Mar 17, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Advance1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATATION PROCEDURE TO TREAT ACHALASIA PERFORMED ON (b)(6) 2026. DURING THE PROCEDURE, FOLLOWING DILATATION, THE PHYSICIAN ADVANCED THE SCOPE INTO THE ESOPHAGUS AND OBSERVED AN ESOPHAGEAL PERFORATION. MULTIPLE MANTIS CLIPS WERE PLACED, SUCCESSFULLY CLOSING THE PERFORATION, AND A FULLY COVERED STENT WAS DEPLOYED. THE PHYSICIAN STATED THAT THE PERFORATION WAS NOT RELATED TO A DEVICE PROBLEM. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL RIGIFLEX II DILATATION BALLOON.THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS UNKNOWN.
Patient problems: Perforation
MAUDE report 24618262 ↗MalfunctionApr 25, 2022Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON WAS DIFFICULT TO ADVANCE CAUSING THE BALLOON TIP TO BE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RIGIFLEX II BALLOON . THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14194477 ↗
Other esophageal dilator balloon with or without electrode sensors devices
- EsoFLIP ES-330Covidien LP · esophageal dilator balloon with or without electrode sensors1 recall91 reports
- RIGIFLEX II M00554500Boston Scientific Corporation · esophageal dilator balloon with or without electrode sensors17 reports
- RIGIFLEX II M00554510Boston Scientific Corporation · esophageal dilator balloon with or without electrode sensors7 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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