CRE™ RX M00558940Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729965497), received between Nov 19, 2018 and Feb 6, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Entrapment of Device; Use of Device Problem; 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 STOMACH AND ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED IN (B)(6) 2025. THE SPECIFIC DATE IS UNKNOWN. DURING THE PROCEDURE, A BILIARY BALLOON DILATATION CATHETER WAS INSERTED INTO AN ENDOSCOPE WITH A 2.8 MM WORKING CHANNEL, WHICH WAS TOO SMALL FOR THE DEVICE. THE CATHETER MET SIGNIFICANT RESISTANCE DURING INSERTION AND DID NOT EXIT THE DISTAL TIP OF THE SCOPE. WHEN THE TEAM PULLED THE DEVICE BACK OUT, THE BLACK RX SHEATH, WHICH IS NOT DESIGNED TO DETACH, WAS TORN OFF AND REMAINED IN THE BIOPSY CHANNEL. IT WAS REPORTED THAT NO PART OF THE DETACHED PIECE FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX DILATATION BALLOON DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE INSTRUCTION FOR USE (IFU) STATES THAT THE CRE RX BILIARY BALLOON DILATATION CATHETER IS DESIGNED TO PASS THROUGH AN ENDOSCOPE WITH A MINIMUM 3.7MM WORKING CHANNEL. HOWEVER, THE COMPLAINANT REPORTED THAT THEY USED THE DEVICE IN A SCOPE WITH TOO SMALL OF A WORKING CHANNEL 2.8MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279791 ↗
• MalfunctionJan 6, 2026Burst Container or Vessel; 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 COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON POPPED UPON INFLATION DURING DILATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23985137 ↗
• MalfunctionFeb 6, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A BALLOON PINHOLE AND THE ANATOMY LOCATION AND PROCEDURE TYPE ARE UNKNOWN AND MAY HAVE OCCURRED IN THE ESOPHAGUS. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324004 ↗
• MalfunctionAug 9, 2023Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT THERE WAS A KINK AT THE DISTAL PART OF THE BALLOON SHEATH. THE SHEATH MUST BE CLIPPED IN THE OPPOSITE DIRECTION TO INFLATE THE BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491139 ↗
• MalfunctionMay 13, 2022Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED IN THE STOMACH AND PANCREAS DURING A DILATATION OF HOTAXIOS PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE DARK PART OF THE BALLOON CATHETER, THE RX TUNNEL, STAYED INSIDE THE WORKING CHANNEL WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON. THE DILATATION WAS COMPLETED AT THIS TIME. THE ENDOSCOPE WAS REMOVED AND THE NURSE TOOK OUT THE BLACK PART USING A CLEANING BRUSH AND THE PROCEDURE WAS COMPLETED WITH A THERAPEUTIC GASTROSCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14400411 ↗
• MalfunctionDec 17, 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 AMPULLA OF VATER 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, THE BLACK RX TUNNEL UNKNOWINGLY DETACHED FROM THE CATHETER INTO THE SCOPE. IT WAS ONLY DISCOVERED WHEN AN EXTRACTOR BALLOON WAS ADVANCED DOWN THE SCOPE AND PUSHED THE RX TUNNEL OUT OF THE TIP OF THE SCOPE, WHICH THEN APPEARED ON THE ENDOSCOPIC IMAGE. THE EXTRACTOR BALLOON WAS THEN WITHDRAWN FROM THE SCOPE, AND THE BLACK RX TUNNEL CAME OUT OF THE SCOPE WITH IT. THE DILATION PROCEDURE WAS CONTINUED AND COMPLETED WITH THE EXTRACTOR 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 11030123 ↗
• 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 8086549 ↗