RIGIFLEX II M00554510Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729719113), received between Sep 20, 2019 and May 23, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionAug 5, 2021Inflation Problem; Appropriate Device Problem Term/Code Not Available; Inflation Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ACHALASIA DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON DID NOT INFLATE. THE PROCEDURE WAS RESCHEDULED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284141 ↗
• InjuryJan 8, 2020Adverse 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 (EDG) WITH DILATATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, AFTER THE DILATATION, IT WAS NOTED THAT THE ESOPHAGUS HAD BEEN PERFORATED. THE PATIENT WAS THEN TRANSFERRED TO (B)(6) WHERE AN EMERGENT SURGERY WAS PERFORMED BY A CARDIO-THORACIC SURGEON. FOLLOWING THE TREATMENT, THE PATIENT CONDITION WAS REPORTED TO BE STABLE. IT WAS NOTED THAT THERE WAS NO MALFUNCTION OF THE RIGIFLEX II DILATATION BALLOON, AND PER THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF THE PERFORATION WAS THE ANATOMY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Code Available; Perforation

  MAUDE report 9564068 ↗
• MalfunctionSep 20, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BALLOON WAS INFLATED OUTSIDE THE PATIENT FOR INSPECTION; HOWEVER, THE BALLOON WOULD NOT FULLY DEFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RIGIFLEX II DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9097538 ↗