CRE™ RX M00558910Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729965466), received between Feb 7, 2019 and Feb 7, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE RX BILIARY DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE RX BILIARY DILATATION BALLOONS WERE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BLACK RX TUNNEL OF THE DEVICE WAS DETACHED INSIDE THE PATIENT. REPORTEDLY, IT WAS NOTED THAT THE WORKING CHANNEL OF THE SCOPE WAS TOO TIGHT DURING ADVANCEMENT OF THE DEVICE DOWN THE SCOPE. THE DETACHED PART WAS RETRIEVED USING A RAT TOOTH FORCEPS. THE SAME ISSUE OCCURRED WITH THE SECOND CRE RX BILIARY DILATATION BALLOON AND THEY COMPLETED THE PROCEDURE AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316870 ↗