CRE™ RX M00558870Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729965428), received between Feb 7, 2019 and Dec 23, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING A SPINCTEROPLASTY OF THE AMPULLA PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST WHEN ATTEMPTING TO DILATE THE CBD; IT WAS NOTICED THAT THE BALLOON BURST AT ROUGHLY 9.5MM. REPORTEDLY, THE STONES WERE SMALL AND WERE NOT HARD OR SHARP. NO PART OF THE BALLOON DETACHED INSIDE THE PATIENT. THE BALLOON WAS THEN REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11064629 ↗
• MalfunctionDec 4, 2020Detachment 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 IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT AFTER SUCCESSFUL DILATION, IT WAS NOTED THAT THE BLACK RX TUNNEL UNKNOWINGLY CAME OFF FROM THE CATHETER INTO THE SCOPE. IT WAS THEN DISCOVERED WHEN AN EXTRACTOR BALLOON HAD EXPERIENCED RESISTANCE ADVANCING DOWN THE SCOPE CHANNEL, WHICH RESULTED IN THE RX TUNNEL BEING PUSHED OUT OF THE TIP OF THE SCOPE AND BEING VISUALIZED ON THE ENDOSCOPY SCREEN. REPORTEDLY, THE SCOPE AND THE DETACHED PIECE THAT REMAINED ATTACHED TO THE SCOPE WERE REMOVED FROM THE PATIENT TOGETHER. THE PROCEDURE WAS COMPLETED USING THE EXTRACTOR BALLOON. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10943393 ↗
• MalfunctionJun 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  BOSTON SCIENTIFIC CORPORATION RECEIVED AN UNAUTHORIZED RETURN OF A CRE RX BILIARY DILATATION BALLOON THAT WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. IT WAS FOUND THAT THE BLACK RX TUNNEL WAS FOUND DETACHED. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX BILIARY DILATATION BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739284 ↗
• MalfunctionMay 1, 2019Entrapment 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 BILIARY DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BLACK RX TUNNEL DETACHED FROM THE CATHETER AND WAS STUCK INSIDE THE SCOPE. REPORTEDLY, THE PHYSICIAN REMOVED THE SCOPE FROM THE PATIENT AND WAS THEN REMOVED THE BLACK RX TUNNEL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570250 ↗
• 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 8316861 ↗