CRE™ RX M00558880Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729965435), received between Nov 19, 2018 and Sep 4, 2026 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Entrapment 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 esophagus, gastric, and duodenum during an Esophagogastroduodenoscopy (EGD) procedure to treat stricture performed on (b)(6) 2026.During the procedure, the black outer catheter was detached and left in the scope channel. Subsequently, it was pushed into the patient and was successfully retrieved using a rescue forceps. The device was removed and the procedure was completed CRE RX Biliary 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 50623626 ↗
• MalfunctionFeb 17, 2026Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR STONE TREATMENT ON (B)(6) 2026. DURING THE PROCEDURE, RESISTANCE WAS FELT BY THE PHYSICIAN WHEN PASSING THE BALLOON DOWN THE WORKING CHANNEL. UPON EXCHANGE AND RETRIEVAL, RESISTANCE WAS ENCOUNTERED AGAIN AND THE BLACK CATHETER SEGMENT HOUSING THE GUIDEWIRE (RAPID EXCHANGE OR RX TUNNEL) BEGAN TO PEEL OFF. THE RX TUNNEL DISLODGED INTO THE WORKING CHANNEL OF THE DUODENAL SCOPE AND FORCEPS WERE USED TO REMOVE IT FROM THE SCOPE. IT WAS REPORTED THAT NO PORTION OF THE DETACHED PIECE FELL INTO THE PATIENT. A PHOTO OF THE COMPLAINT DEVICE SHOWED THE RX TUNNEL DETACHED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366786 ↗
• MalfunctionFeb 2, 2026

  DURING PT'S ERCP [(ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY)], THERE WAS RESISTANCE FELT BY THE MD WHILE PASSING THE CRE BILIARY BALLOON DILATION CATHETER DOWN THE WORKING CHANNEL BUT WAS UNABLE TO PROPERLY UTILIZE EQUIPMENT FOR ITS INTENDED PURPOSE. UPON EXCHANGING, RESISTANCE WAS ONCE AGAIN FELT BY THE MD AND THEN A BLACK STRAW LIKE PIECE CAME OUT OF THE WORKING CHANNEL OF THE DUODENAL SCOPE. IT SHOULD BE NOTED THAT THE FOREIGN BODY NEVER ENTERED THE PATIENT. UPON FURTHER INVESTIGATION AFTER THE CASE, IT WAS DETERMINED THAT THE GUIDE WIRE SHEATH BROKE OFF THE DILATION BALLOON DURING INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229058 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A GASTROSCOPY WITH DILATATION PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, ADVANCING THE CATHETER WAS INITIALLY DIFFICULT, BUT THE PROCESS EVENTUALLY WENT WELL. DILATATION WAS PERFORMED, AND WHEN SWITCHING TO A LARGER DILATION BALLOON, THE PHYSICIAN NOTICED THAT A COMPONENT (THE BLACK COVER) WAS MISSING FROM THE BALLOON. THE SCOPE WAS CHANGED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER GASTROSCOPE AND A LARGER DILATION BALLOON. LATER, THE MISSING BLACK COVER WAS FOUND INSIDE THE FIRST GASTROSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770133 ↗
• MalfunctionFeb 23, 2021Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED IN THE COLON DURING A COLONIC STENT PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE, THE BLACK PORTION OF THE CATHETER DETACHED INSIDE THE PATIENT. IT IS UNKNOWN IF THE DETACHED PIECE HAS BEEN RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE OKAY. NOTE: THE INSTRUCTIONS FOR USE (IFU) STATES THAT THIS DEVICE IS NOT INDICATED FOR USE IN THE COLON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11365895 ↗
• MalfunctionMar 16, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT IT WAS HARD TO MAINTAIN 3 ATM PRESSURE ON THE BALLOON AFTER FEW SECONDS OF INFLATION. THE NURSE HAD TO CONTINUALLY PUMP THE HANDLE TO MAINTAIN THE PRESSURE OF THE BALLOON. REPORTEDLY, THE DEVICE WAS REMOVED FOR INSPECTION AND A LEAK WAS NOTED IN THE BALLOON DUE TO A PINHOLE AT THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED AT THIS TIME. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9837514 ↗
• MalfunctionNov 19, 2018Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2018-61371 PERTAINS TO THE FIRST CRE RX DILATATION BALLOON, AND MANUFACTURER REPORT # 3005099803-2018-61367 PERTAINS TO THE SECOND CRE RX DILATATION BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE RX DILATATION BALLOON WERE USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS DIFFICULTY IN ADVANCING THE DEVICE DOWN THE SCOPE. REPORTEDLY, THE DEVICE GOT STUCK IN THE WORKING CHANNEL AND THEY HAD TROUBLE GETTING IT OUT. IT WAS THEN THAT THE CATHETER SNAPPED. NONE OF THE CATHETER WAS INSIDE THE PATIENT. THE SCOPE WAS TAKEN OUT OF THE PATIENT, AND THE DEVICE WAS REMOVED FROM THE SCOPE. THE SAME ISSUE OCCURRED WITH THE SECOND CRE RX DILATATION BALLOON. 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 Consequences Or Impact To Patient

  MAUDE report 8086656 ↗