RIGIFLEX IIRecalls & reported problems across all models
Boston Scientific Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 3 models of RIGIFLEX II by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Sep 20, 2019 and Mar 17, 2026 — classified as 4 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (18 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 RIGIFLEX II problems
Device problems
- Burst Container or Vessel18
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Deflation Problem1
- Difficult to Advance1
- Inflation Problem1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Consequences Or Impact To Patient4
- Perforation3
- No Code Available1
- Perforation of Esophagus1
RIGIFLEX II models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RIGIFLEX II M00554500esophageal dilator balloon with or without electrode sensors17 reports
- RIGIFLEX II M00554510esophageal dilator balloon with or without electrode sensors7 reports
- RIGIFLEX II M00554520esophageal dilator balloon with or without electrode sensors2 reports
Recent RIGIFLEX II adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMay 23, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A LOWER ESOPHAGEAL SPHINCTER (LES) DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RIGIFLEX II DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22080670 ↗MalfunctionMay 12, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RIGIFLEX II DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22003677 ↗MalfunctionJan 24, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A LOWER ESOPHAGEAL SPHINCTER (LES) DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RIGIFLEX II DILATATION BALLOON. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21233639 ↗MalfunctionJan 10, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC DILATATION PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, THE BALLOON BURST. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21127686 ↗MalfunctionJul 11, 2024Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON BURST. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RIGIFLEX II DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19720426 ↗InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE ESOPHAGUS WAS PERFORATED. THE ENDOSCOPIST BELIEVED THAT THE PERFORATION WAS CAUSED BY THE RIGID TIP OF THE TUBE RATHER THAN BY BALLOON INFLATION. THIS WAS A SMALL AND LOCALIZED PERFORATION. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. THE PATIENT WAS 72 YEARS OLD MALE. THE PERFORATION WAS THEN TREATED USING FEW ENDO CLIPS. THE PATIENT UNDERGOES NOTHING BY MOUTH (NBM) AND ON TOTAL PARENTERAL NUTRITION (TPN) DUE TO THIS EVENT. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED HOME AFTER A WEEK ONCE THE BARIUM DID NOT DEMONSTRATE ANY LEAK.
Patient problems: Perforation of Esophagus
MAUDE report 18499052 ↗MalfunctionJul 25, 2023Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II BALLOON WAS USED IN THE LOWER ESOPHAGEAL SPHINCTER (LES) DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17393704 ↗MalfunctionJan 25, 2023Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE FOR TEST PERIOD, THE STAFF OPENED THE PACKAGED AND NOTICED THAT THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16243705 ↗MalfunctionDec 16, 2022Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED IN THE LOWER ESOPHAGEAL SPHINCTER DURING AN ENDOSCOPIC DILATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 20 PSI AFTER ONLY ONE MINUTE OF DILATING. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE HAD ALREADY BEEN COMPLETED SUCCESSFULLY WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15998007 ↗MalfunctionNov 21, 2022Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II BALLOON WAS USED IN A PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15840288 ↗MalfunctionAug 16, 2022Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ACHALASIA DILATATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER RIGIFLEX II DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION WAS REPORTED TO BE FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15235315 ↗InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse 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 ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. AFTER THE PROCEDURE, WHEN THE PHYSICIAN LOOKED IN THE ESOPHAGUS POST DILATION, PERFORATION WAS NOTICED. ENDOSCOPIC CLOSURE WAS ATTEMPTED BUT A SURGICAL INTERVENTION WAS NEEDED. SURGERY WAS SUCCESSFUL; HOWEVER, THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. THERE WAS NO ALLEGED PROBLEM WITH THE BALLOON. THE PATIENT CONDITION FOLLOWING THE INTERVENTION WAS REPORTED TO BE STABLE.
Patient problems: Perforation
MAUDE report 14738865 ↗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 ↗MalfunctionJan 5, 2022Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II BALLOON WAS PREPARED FOR USE IN AN ACHALASIA BALLOONING PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER RIGIFLEX II BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13171629 ↗
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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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