CRE Wireguided M00558470Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729339403), received between Dec 21, 2017 and Sep 22, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 21, 2026Open, Classified

   Potential sterile breach of the pouches in which devices are packaged.

   Z-2634-2026 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859313 ↗
• MalfunctionMay 7, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976251 ↗
• MalfunctionApr 3, 2024Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON COULD NOT BE INFLATED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. 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 BURST. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19034335 ↗
• MalfunctionMar 21, 2024Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED BUT IT WOULD NOT INFLATE. IT WAS REMOVED FROM THE ENDOSCOPE AND AN ATTEMPT TO INFLATE THE BALLOON OUTSIDE THE PATIENT WAS MADE. HOWEVER, THE BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A BALLOON PINHOLE THAT OCCURRED IN THE ESOPHAGUS. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18950970 ↗
• MalfunctionMar 23, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS UNPACKED TO BE USED IN THE BILE DUCT FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS NOTICED THAT THE TIP OF THE BALLOON WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 13866139 ↗
• MalfunctionNov 29, 2021Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATION BALLOON WAS USED IN ESOPHAGUS DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE BALLOON WAS BEING INFLATED WITH WATER, IT WAS NOT RESPONDING. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND HELD OUT AND ASKED TO BE REFILLED AND TRY AGAIN, THE PRODUCT WAS NOTED TO BE LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATION 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 BALLOON PINHOLE. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888795 ↗
• MalfunctionAug 10, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, A HOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 12298913 ↗
• MalfunctionMay 26, 2021Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED BALLOON WAS USED DURING A BALLOON DILATATION PROCEDURE PERFORMED IN THE COLON ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON LEAKED. THE USER NOTED THAT THERE WERE NO VISIBLE ISSUES OR DAMAGE TO THE BALLOON. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION WHICH REVEALED A UNREPORTED FAILURE MODE: BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890340 ↗
• MalfunctionNov 25, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED FOR A CHOLANGIECTASIS PROCEDURE PERFORMED IN THE BILE DUCT ON (B)(6)2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON HAD A PINHOLE AND WAS LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. THERE HAVE BEEN 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 9369947 ↗
• MalfunctionOct 4, 2019Entrapment of Device; Problem with Sterilization; Entrapment of Device; Problem with Sterilization

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE PROTECTIVE SLEEVE OF THE BALLOON WAS NOT REMOVED PRIOR TO USE AND DETACHED INSIDE THE SCOPE. REPORTEDLY, THE DETACHED PART WAS MISTAKENLY LEFT INSIDE THE SCOPE AND WAS USED IN MULTIPLE PROCEDURES ON UNKNOWN DATES BEFORE BEING DISCOVERED. THE EXACT NUMBER OF PROCEDURES IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9157943 ↗
• MalfunctionSep 5, 2019Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED IN THE ESOPHAGUS ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON COULD NOT BE INFLATED. IT WAS NOTED THAT THE WIRE WAS KINKED AT THE BALLOON PORTION OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8966009 ↗
• MalfunctionJun 19, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED 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, IT WAS NOTED THAT THE BALLOON WOULD NOT SHOW IMAGE UNDER FLUOROSCOPY. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT AND A HOLE WAS NOTED ON THE BALLOON DURING INSPECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED 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 STABLE. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8713439 ↗
• MalfunctionMay 16, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BALLOON WAS TESTED, AND IT WAS NOTICED THAT THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED 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 STABLE. INVESTIGATION RESULTS REVEALED THAT THE BALLOON FOUND A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616386 ↗
• MalfunctionMar 21, 2019Entrapment of Device; Detachment of Device or Device Component; Material Deformation; Entrapment of Device; Detachment of Device or Device Component; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE WIREGUIDED DILATATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE WIREGUIDED DILATATION BALLOONS DEVICE WERE USED IN THE DUODENUM DURING A DUODENAL DILATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BLACK EXIT MARKER WAS NOTED TO BE BUNCHED UP LIKE AN ACCORDION. IT WAS ALSO NOTED THAT IT WAS SQUISHED AND GOT WIDER WHICH PREVENTED THE PHYSICIAN FROM MOVING THE BALLOON AT ALL. REPORTEDLY, THE DEVICE ENDED UP LODGED IN THE SCOPE, SO THE BALLOON WAS REMOVED TOGETHER WITH THE ENDOSCOPE. THE PHYSICIAN THEN CUT THE CATHETER IN HALF WITH WIRE CUTTERS TO REMOVE THE DEVICE FROM THE SCOPE. THEY USED A SECOND CRE WIREGUIDED DILATATION BALLOON, AND THE SAME EVENT OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD CRE WIREGUIDED DILATATION BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439991 ↗
• MalfunctionMar 21, 2019Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE WIREGUIDED DILATATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE WIREGUIDED DILATATION BALLOONS DEVICE WERE USED IN THE DUODENUM DURING A DUODENAL DILATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BLACK EXIT MARKER WAS NOTED TO BE BUNCHED UP LIKE AN ACCORDION. IT WAS ALSO NOTED THAT IT WAS SQUISHED AND GOT WIDER WHICH PREVENTED THE PHYSICIAN FROM MOVING THE BALLOON AT ALL. REPORTEDLY, THE DEVICE ENDED UP LODGED IN THE SCOPE, SO THE BALLOON WAS REMOVED TOGETHER WITH THE ENDOSCOPE. THE PHYSICIAN THEN CUT THE CATHETER IN HALF WITH WIRE CUTTERS TO REMOVE THE DEVICE FROM THE SCOPE. THEY USED A SECOND CRE WIREGUIDED DILATATION BALLOON, AND THE SAME EVENT OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD CRE WIREGUIDED DILATATION BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439975 ↗
• MalfunctionFeb 26, 2019Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING A BILIARY DILATION PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BALLOON WAS PRE-INFLATED AND IT WAS NOTICED THAT THE BALLOON LEAKED. THE PROCEDURE WAS NOT COMPLETED AS ANOTHER OF THE SAME DEVICE WAS NOT AVAILABLE. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INVESTIGATION RESULTS REVEALED THAT THE BALLOON FOUND A PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8371785 ↗
• MalfunctionDec 21, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON AN (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, THE BALLOON WAS NOT IN A TIGHT WINGFOLDED POSITION ONCE THE WINGTOOL WAS REMOVED FROM THE BALLOON AND IT WAS UNABLE TO FIT THROUGH THE BIOPSY CAP. IT WAS ALSO REPORTED THAT THE DISTAL TIP OF THE CATHETER WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED 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 Consequences Or Impact To Patient

  MAUDE report 7138201 ↗