CRE Fixed Wire M00558340Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729201991), received between May 3, 2018 and Jan 2, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Burst Container or Vessel; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT AN ESOPHAGEAL STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THIS BALLOON SHOULD NOT BE PRE-INFLATED PRIOR TO USE IN THE PROCEDURE. HOWEVER, THE CUSTOMER REPORTED THAT THE BALLOON WAS PRE-INFLATED OUTSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952210 ↗
• MalfunctionMay 7, 2025Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE GOOD. NOTE: THE INSTRUCTION FOR USE (IFU) STATES THAT THE CRE FIXED WIRE BALLOON DILATATION CATHETERS ARE INDICATED FOR USE IN ADULT AND ADOLESCENT POPULATIONS TO ENDOSCOPICALLY DILATE STRICTURES OF THE ESOPHAGUS. HOWEVER, THE COMPLAINANT REPORTED THAT THE ANATOMY LOCATION OF THE PROCEDURE WAS AT THE COMMON BILE DUCT (CBD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977709 ↗
• MalfunctionMar 21, 2025Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE TECHNICIAN INFLATED THE BALLOON, AND THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21670992 ↗
• InjuryJan 17, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED IN THE PATIENT'S ESOPHAGUS AND MOVING FREELY, THE BALLOON POPPED. IT WAS REPORTED THAT THE BALLOON WAS ABLE TO BE INFLATED BETWEEN 8 MM AND 9 MM AND WAS ABLE TO SLIDE WITHOUT FULL DISTENSION OF THE WALLS OF THE STENOSIS AND WITHOUT TENSION ON THE BALLOON. HOWEVER, WHEN THE BALLOON WAS ATTEMPTED TO BE INFLATED TO 10 MM, THE BALLOON RUPTURED AND LEAKED STERILE WATER. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. A TEAR OF THE STENOSIS WAS OBSERVED. THE DILATION SITE WAS EXAMINED AND SHOWED MODERATE MUCOSAL DISRUPTION. THE PATIENT WAS SENT FOR AN ESOPHAGRAM, ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AT ANOTHER FACILITY, AND TRANSPORTED TO A HIGHER LEVEL OF CARE. SURGERY WAS NOT REQUIRED BUT THE PATIENT WAS SUPPORTED WITH INTRAVENOUS (IV) FLUIDS AND ANTIBIOTICS.

  Patient problems: Laceration(s); Unspecified Tissue Injury

  MAUDE report 21182748 ↗
• MalfunctionJun 7, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING WITHDRAWAL, AFTER COMPLETING THE DILATATION OF THE TARGET SITE, AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON, HOWEVER, THE BALLOON COULD NOT BE DEFLATED COMPLETELY. DESPITE SEVERE RESISTANCE AS IT WAS NOT DEFLATED COMPLETELY, THE DEVICE WAS FORCEFULLY REMOVED FROM THE FORCEPS CHANNEL. THE PROCEDURE HAD ALREADY BEEN COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491528 ↗
• MalfunctionFeb 7, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AS THE PHYSICIAN INFLATED THE BALLOON, THE BALLOON TWISTED AND BURST INSIDE THE PATIENT. NO FURTHER EVENT INFORMATION WAS PROVIDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660116 ↗
• MalfunctionMay 18, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A GASTROINTESTINAL DILATATION PROCEDURE PERFORMED ON (B)(6)2023. DURING THE PROCEDURE, THE BALLOON COULD NOT BE INFLATED. THE DEVICE WAS THEN REMOVED FROM THE PATIENT'S BODY AND WAS CHECKED, A LEAK WAS NOTICED FROM THE BASE OF THE BALLOON COMING FROM A SMALL HOLE. THE PROCEDURE WAS COMPLETED WITH A CRE WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955812 ↗
• MalfunctionAug 16, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHILE INFLATING THE BALLOON, IT BEGAN TO LEAK AND A HOLE WAS DISCOVERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234845 ↗
• MalfunctionMar 16, 2022Burst Container or Vessel; Leak/Splash; Use of Device Problem; Burst Container or Vessel; Leak/Splash; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON LEAKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE RX DILATION BALLOON. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THIS BALLOON SHOULD NOT BE PRE-INFLATED PRIOR TO USE IN THE PROCEDURE. HOWEVER, THE CUSTOMER REPORTED THAT THE BALLOON WAS PRE-INFLATED OUTSIDE OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS OF BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13780771 ↗
• MalfunctionFeb 23, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON POPPED WHILE BEING INFLATED TO 9MM. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583420 ↗
• MalfunctionApr 16, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT WHEN THE PHYSICIAN UNPACKED THE DEVICE, IT WAS NOTICED THAT THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11680323 ↗
• MalfunctionApr 2, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING AN OESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE WHEN INSIDE THE PATIENT. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT FOR INSPECTION, AND IT WAS NOTICED THAT THE BALLOON WAS LEAKING DUE TO A HOLE. ADDITIONAL CLARIFICATION TO DETERMINE THE SIZE/NATURE OF THE HOLE HAS NOT BEEN PROVIDED, SO THE REPORTED EVENT WILL BE CONSIDERED A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610642 ↗
• MalfunctionSep 28, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON COULD NOT BE INFLATED BECAUSE IT BUSTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10593813 ↗
• MalfunctionJun 29, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON POPPED WHILE BEING INFLATED TO 10MM. REPORTEDLY, THE BALLOON WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION 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 10209124 ↗
• InjuryApr 30, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED INSIDE THE PATIENT WHICH CAUSED MINIMAL TISSUE DAMAGE. REPORTEDLY, THE INJURY WAS TREATED "NORMALLY" AND THE PATIENT WAS MONITORED FOR BLEEDING. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: Tissue Damage

  MAUDE report 8566692 ↗
• MalfunctionNov 28, 2018Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS/GE JUNCTION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST AND A PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. REPORTEDLY, THE DETACHED BALLOON MATERIAL WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8110515 ↗
• MalfunctionAug 8, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATION BALLOON WAS USED ON A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DEFECTIVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INVESTIGATION RESULTS REVEALED THAT THE DISTAL TIP OF THE BALLOON WAS BENT; THEREFORE THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7761518 ↗
• InjuryMay 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A BENIGN STRICTURE WAS DILATED AND A PERFORATION OCCURRED. THE PERFORATION WAS THEN SEALED AND TREATED USING A FULLY COVERED PLASTIC STENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. REPORTEDLY, THERE WAS NO MALFUNCTION OF THE BALLOON, AND THE PHYSICIAN DOES NOT BELIEVE THE PERFORATION WAS CAUSED BY THE BALLOON. IN THE PHYSICIAN¿S ASSESSMENT, IT IS UNKNOWN WHAT CAUSED THE PERFORATION. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE DOING WELL.

  Patient problems: Perforation

  MAUDE report 7482675 ↗