CRE™ RX M00558900Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729965459), received between May 20, 2022 and May 20, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Entrapment of Device; Problem with Sterilization; Entrapment of Device; Problem with Sterilization

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS USED DURING A DILATION PROCEDURE. THE EXACT DATE OF THE PROCEDURE WAS NOT PROVIDED. DURING A PROCEDURE, THE CRE RX DILATATION BALLOON WAS USED IN A SCOPE TO TREAT A PATIENT BY DILATION. UPON REMOVAL, THE RX TUNNEL HAD DETACHED IN THE SCOPE BUT WAS NOT NOTICED. THE SCOPE WAS USED IN A SECOND PATIENT FOR POLYPECTOMY AND THIRD PATIENT FOR AN UNKNOWN PROCEDURE. DURING THE PROCEDURE FOR THE THIRD PATIENT, RESISTANCE WAS NOTED IN THE WORKING CHANNEL OF THE SCOPE. THE SCOPE WAS TAKEN TO MEDICAL TECHNOLOGY, CLEANED WITH A BRUSH, AND A BLACK SLEEVE CAME OUT. THE PROCEDURES WERE COMPLETED WITH THE ORIGINAL DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462508 ↗
• MalfunctionMay 20, 2022Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS USED DURING A DILATION PROCEDURE. THE EXACT DATE OF THE PROCEDURE WAS NOT PROVIDED. DURING A PROCEDURE, THE CRE RX DILATATION BALLOON WAS USED IN A SCOPE TO TREAT A PATIENT BY DILATION. UPON REMOVAL, THE RX TUNNEL HAD DETACHED IN THE SCOPE BUT WAS NOT NOTICED. THE SCOPE WAS USED IN A SECOND PATIENT FOR POLYPECTOMY AND THIRD PATIENT FOR AN UNKNOWN PROCEDURE. DURING THE PROCEDURE FOR THE THIRD PATIENT, RESISTANCE WAS NOTED IN THE WORKING CHANNEL OF THE SCOPE. THE SCOPE WAS TAKEN TO MEDICAL TECHNOLOGY, CLEANED WITH A BRUSH, AND A BLACK SLEEVE CAME OUT. THE PROCEDURES WERE COMPLETED WITH THE ORIGINAL DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461501 ↗
• MalfunctionMay 20, 2022Entrapment of Device; Problem with Sterilization; Entrapment of Device; Problem with Sterilization

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS USED DURING A DILATION PROCEDURE. THE EXACT DATE OF THE PROCEDURE WAS NOT PROVIDED. DURING A PROCEDURE, THE CRE RX DILATATION BALLOON WAS USED IN A SCOPE TO TREAT A PATIENT BY DILATION. UPON REMOVAL, THE RX TUNNEL HAD DETACHED IN THE SCOPE BUT WAS NOT NOTICED. THE SCOPE WAS USED IN A SECOND PATIENT FOR POLYPECTOMY AND THIRD PATIENT FOR AN UNKNOWN PROCEDURE. DURING THE PROCEDURE FOR THE THIRD PATIENT, RESISTANCE WAS NOTED IN THE WORKING CHANNEL OF THE SCOPE. THE SCOPE WAS TAKEN TO MEDICAL TECHNOLOGY, CLEANED WITH A BRUSH, AND A BLACK SLEEVE CAME OUT. THE PROCEDURES WERE COMPLETED WITH THE ORIGINAL DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461422 ↗