CRE™ PRO M00558660Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729797548), received between Sep 14, 2018 and Jul 16, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. May 21, 2026Open, Classified

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

   Z-2626-2026 · Root cause: Package design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850510 ↗
• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS RECEIVED BY THE CUSTOMER ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PRODUCTS WERE REPORTED AS DAMAGED UPON RECEIPT BY THE CUSTOMER. THE PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT, AND THE PRODUCT WAS NOT USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850271 ↗
• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850255 ↗
• MalfunctionOct 20, 2025Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING A PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED, IT DID NOT INFLATE. A BALLOON RUPTURE WAS EVIDENT. IT WAS REPORTED THAT NO PART OF THE DEVICE DETACHED AND FELL INTO THE PATIENT. 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 23339728 ↗
• MalfunctionMay 8, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON HAD A HOLE AND COULD NOT BE INFLATED. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. THE ANATOMY LOCATION OF THE PROCEDURE IS UNKNOWN AND IS BEING REPORTED AS IT 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 19271940 ↗
• InjuryMar 21, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PHYSICIAN PERFORMED A COLONOSCOPY PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN INSERTED BIOPSY FORCEPS INTO THE BIOPSY PORT OF THE SCOPE AND PUSHED A CLEAR PLASTIC SHEATH INTO THE COLON OF THE PATIENT. THE PLASTIC SHEATH WAS REMOVED FROM THE PATIENT USING A SNARE AND THE PROCEDURE WAS COMPLETED AT THIS TIME. THE CLEAR SHEATH APPEARED TO BE A SHEATH FROM A CRE PRO WIREGUIDED DILATATION BALLOON USED DURING THE PREVIOUS PROCEDURE THAT WAS STUCK IN THE SCOPE. THE PHYSICIAN REPORTED THAT NO IMMEDIATE HARM WAS CAUSED TO THE PATIENT BUT NOTED A RISK OF INFECTION RELATED TO THE IMPROPERLY REPROCESSED SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583753 ↗
• MalfunctionOct 5, 2022Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A DILATATION PROCEDURE PERFORMED ON AN (B)(6), 2022. DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON WAS BENT AT THE TOP/BALLOON WHEN TAKEN OUT ON THE PACKAGING. 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 15547031 ↗
• MalfunctionOct 22, 2020Material Puncture/Hole; Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Material Puncture/Hole; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING A SUBGLOTTIC STENOSIS DILATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE BECAUSE IT WAS PUNCTURED. REPORTEDLY, THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. 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 10722077 ↗
• MalfunctionOct 1, 2020Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY DILATATION BALLOONS AND A CRE PRO WIREGIDED DILATATION BALLOON USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATATION BALLOONS AND A CRE PRO WIREGIDED DILATATION BALLOON WERE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT ALL THE THREE BALLOONS WERE LEAKING. REPORTEDLY, THE CRE BALLOON WAS TESTED PRIOR TO USE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 10614363 ↗
• MalfunctionOct 28, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS UNPACKED FOR A DILATATION PROCEDURE TO BE PERFORMED IN THE DUODENUM ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, WHEN UNPACKED, THERE WERE PINHOLES NOTED ON THE STERILE DEVICE POUCH WHICH COMPROMISED THE STERILITY OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247016 ↗
• MalfunctionJun 11, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS INSPECTED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING INSPECTION OF THE STORED PRODUCTS, IT WAS NOTED THAT THE PACKAGING OF THE DEVICE WAS DETERIORATED AND THE STERILE BARRIER WAS COMPROMISED. THIS WAS FOUND PRIOR TO USE WITH A PATIENT OR PROCEDURE. 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 Patient Involvement

  MAUDE report 8688358 ↗
• MalfunctionJun 11, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS INSPECTED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING INSPECTION OF THE STORED PRODUCTS, IT WAS NOTED THAT THE PACKAGING OF THE DEVICE WAS DETERIORATED AND THE STERILE BARRIER WAS COMPROMISED. THIS WAS FOUND PRIOR TO USE WITH A PATIENT OR PROCEDURE. 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 Patient Involvement

  MAUDE report 8688357 ↗
• MalfunctionNov 8, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT DURING A DOUBLE BALLOON ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, SOME INDENTATIONS OR LITTLE PINHOLES WERE NOTICED IN THE PACKAGING. REPORTEDLY, THE PROCEDURE WAS CONTINUED USING THE SAME DEVICE; HOWEVER, THE BALLOON WOULD NOT INFLATE. THE DEVICE WAS REMOVED AND ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8051365 ↗
• MalfunctionSep 14, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE DUODENAL BULB DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED. 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 Consequences Or Impact To Patient

  MAUDE report 7877231 ↗