CRE RXRecalls & reported problems across all models
Boston Scientific Corporation · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 9 models of CRE RX by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Nov 19, 2018 and Sep 4, 2026 — classified as 12 injuries, 56 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (29 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CRE RX problems
Device problems
- Detachment of Device or Device Component29
- Burst Container or Vessel15
- Entrapment of Device15
- Material Puncture/Hole9
- Adverse Event Without Identified Device or Use Problem7
- Problem with Sterilization6
- Use of Device Problem6
- Difficult to Advance4
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- No Consequences Or Impact To Patient15
- Hemorrhage/Blood Loss/Bleeding2
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
- Pancreatitis1
CRE RX models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CRE™ RX M00558930CATHETER, BILIARY, DIAGNOSTIC17 reports
- CRE™ RX M00558920CATHETER, BILIARY, DIAGNOSTIC15 reports
- CRE™ RX M00558860CATHETER, BILIARY, DIAGNOSTIC7 reports
- CRE™ RX M00558880CATHETER, BILIARY, DIAGNOSTIC7 reports
- CRE™ RX M00558940CATHETER, BILIARY, DIAGNOSTIC7 reports
- CRE™ RX M00558890CATHETER, BILIARY, DIAGNOSTIC6 reports
- CRE™ RX M00558870CATHETER, BILIARY, DIAGNOSTIC5 reports
- CRE™ RX M00558900CATHETER, BILIARY, DIAGNOSTIC3 reports
- CRE™ RX M00558910CATHETER, BILIARY, DIAGNOSTIC1 report
Recent CRE RX adverse event reports
The 15 most recent reports across all models, 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 ↗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 25850516 ↗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 ↗MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25850252 ↗MalfunctionJun 19, 2026Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 25568569 ↗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 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS USED IN THE BILE DUCT DURING A CHOLANGOIOSCOPY PROCEDURE TO TREAT JAUNDICE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, TWO SCIVITA SCOPES WERE USED; HOWEVER, NEITHER PROVIDED AN IMAGE OR SIGNAL ON THE MONITOR. A LARGER SCIVITA SCOPE WAS THEN USED, BUT IT WAS TOO LARGE TO ACCESS THE BILE DUCT. AS A RESULT, THE PHYSICIAN PERFORMED A BALLOON SPHINCTEROPLASTY, WHICH LED TO MAJOR HEMORRHAGE. THE BLEEDING WAS MANAGED WITH AN ADRENALINE INJECTION AND PLACEMENT OF A FULLY COVERED METAL STENT. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED PANCREATITIS. DUE TO THESE EVENTS, THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS REPORTED TO HAVE RECOVERED AFTER EMBOLIZATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis
MAUDE report 24748832 ↗MalfunctionMar 5, 2026Burst Container or Vessel; Inflation Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING A STONE REMOVAL PROCEDURE FOR A BILE DUCT STONE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON COULD NOT BE PROPERLY EXPANDED AND REPORTEDLY RUPTURED. IT WAS REPORTED THAT THE BALLOON BURST AT A PRESSURE/DIAMETER OF 3ATM/10MM. NO PIECE OF BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24527452 ↗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 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 ↗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 ↗MalfunctionJan 22, 2026Inflation Problem; Leak/Splash
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, BALLOON INFLATION WAS OBSERVED TO BE WEAK. UPON REMOVAL AND SUBSEQUENT TABLE TESTING, LEAKAGE WAS DETECTED AT THE DISTAL END OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX DILATATION BALLOON DEVICE. THE TYPE OF PROCEDURE AND THE ANATOMY LOCATION OF THE PROCEDURE ARE UNKNOWN AND ARE BEING REPORTED AS THE BALLOON LEAK MAY HAVE OCCURRED IN THE ESOPHAGUS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24152569 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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