CRE™ RX M00558890Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729965442), received between Jan 22, 2019 and Aug 12, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Detachment of Device or Device Component; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50217663 ↗
• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850511 ↗
• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850272 ↗
• InjuryApr 28, 2026Entrapment of Device; Problem with Sterilization; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS USED IN THE ESOPHAGUS, STOMACH AND DUODENUM DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR DIAGNOSTICS PERFORMED ON (B)(6) 2026 DURING A PREVIOUS PROCEDURE PERFORMED ON AN UNKNOWN DATE, WHEN A CRE RX DILATATION BALLOON WAS INSERTED INTO THE WORKING CHANNEL OF THE SCOPE, THE BALLOON GOT STUCK HALFWAY. THE BALLOON WAS REMOVED. IT WAS REPORTED THAT RX TUNNEL BECAME LOOSE FROM THE PURPLE SHAFT AND WAS DETACHED AND LEFT INSIDE THE SCOPE UNNOTICED. DURING ANOTHER PROCEDURE ON (B)(6) 2026, WHILE USING A BIOPSY FORCEPS, IT WAS REPORTED THAT THE DETACHED RX TUNNEL WAS PUSHED OUT FROM THE WORKING CHANNEL OF THE SCOPE AND INTO THE PATIENT. UPON CHECKING, IT WAS POSITIVELY IDENTIFIED TO HAVE COME FROM THE CRE RX BALLOON FROM THE PREVIOUS PROCEDURE. THE DETACHED PART WAS SUCCESSFULLY RETRIEVED WITH A GRASPER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND 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 25023650 ↗
• MalfunctionApr 28, 2026Entrapment 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 PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN A CRE RX DILATATION BALLOON WAS INSERTED INTO THE WORKING CHANNEL OF THE SCOPE, THE BALLOON GOT STUCK HALFWAY. THE BALLOON WAS REMOVED. IT WAS REPORTED THAT RX TUNNEL BECAME LOOSE FROM THE PURPLE SHAFT AND WAS DETACHED AND LEFT INSIDE THE SCOPE UNNOTICED. DURING A SEPARATE PROCEDURE ON MARCH 27, 2026, THE BIOPSY FORCEPS PUSHED OUT A FOREIGN MATERIAL FROM THE WORKING CHANNEL OF THE SCOPE AND INTO THE PATIENT. UPON CHECKING, IT WAS POSITIVELY IDENTIFIED TO HAVE COME FROM THE CRE RX BALLOON FROM THE PREVIOUS PROCEDURE. THE DETACHED PART WAS SUCCESSFULLY RETRIEVED WITH A GRASPER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND 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 25023038 ↗
• MalfunctionJan 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED DURING A DILATION OF THE PAPIL OF VATER PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, WHEN THE PACKAGE WAS OPENED, IT WAS NOTED THAT THE BLACK RX TUNNEL OF THE DEVICE WAS DETACHED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX BILIARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8267918 ↗