CRE™ PRO M00558670Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08714729797555), received between Oct 11, 2018 and Aug 21, 2026 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (12 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-2627-2026 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50364913 ↗
• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850509 ↗
• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850273 ↗
• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850263 ↗
• MalfunctionApr 13, 2026Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON LEAKED FROM THE DISTAL END AND FAILED TO INFLATE. ADDITIONALLY, A HOLE WAS NOTICED ON THE TIP OF 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24862929 ↗
• MalfunctionMar 25, 2026Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A PROBLEM IN THE INFLATION OF THE BALLOON WAS OBSERVED. THE HOSPITAL LATER REPORTED THAT THE DEVICE WAS FOUND TO BE PUNCTURED. THE EXACT ANATOMY LOCATION AND TYPE OF PROCEDURE WHEN THE BALLOON PINHOLE WAS ENCOUNTERED IS UNKNOWN AND IS BEING REPORTED AS IT MAY HAVE OCCURRED IN THE ESOPHAGUS. 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 24694417 ↗
• MalfunctionMar 13, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT STRICTURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE WAS INFLATED BUT BURST WITHIN SECONDS WHILE IN THE STRICTURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598975 ↗
• MalfunctionMar 13, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT STRICTURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE WAS INFLATED BUT BURST WITHIN SECONDS WHILE IN THE STRICTURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595487 ↗
• MalfunctionMar 13, 2026Tear, Rip or Hole in Device Packaging; Adverse Event Without Identified Device or Use Problem

  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 UPON RECEIVING THE PACKAGING, THE BALLOON PACKAGING WAS PERFORATED/TORN IN THE AREAS WHERE THE SCRATCHES ARE OBSERVED. MEDIA INSPECTION OF THE PRODUCT PACKAGING PROVIDED BY THE COMPLAINANT REVEALED MULTIPLE SMALL PUNCTURES AND INDENTATIONS LOCATED ON THE STERILE POUCH. THE DAMAGE APPEARS AS SEVERAL CLUSTERED PIN SIZED PENETRATIONS AND SURFACE DENTS ON THE FRONT SIDE OF THE STERILE POUCH. THE COMPLAINANT ALSO REPORTED THAT THE OUTER SHIPPING BOX CONTAINING THE STERILE BALLOON POUCHES SHOWED NO SIGNS OF DAMAGE. THE DEVICE WAS NOT USED IN A PROCEDURE. NO PATIENT WAS INVOLVED AT THE TIME OF EVENT, AND NO PATIENT COMPLICATIONS WERE REPORTED IN CONNECTION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595474 ↗
• MalfunctionSep 9, 2024Burst 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 PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE UPPER DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON POPPED. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE 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 20168944 ↗
• MalfunctionJan 4, 2024Tear, 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 BEING PREPARED FOR USE IN A DILATION PROCEDURE TO BE PERFORMED ON AN UNKNOWN DATE. PRIOR TO THE PROCEDURE, A HOLE WAS NOTICED IN THE DEVICE PACKAGING. A PHOTO OF THE DEVICE PACKAGING WAS PROVIDED BY THE CUSTOMER AND SHOWS THAT THE STERILE POUCH OF THE DEVICE PACKAGING HAS MULTIPLE HOLES AND SCRATCH MARKS. THE PRODUCT WAS DISPOSED BY THE USER AND WAS NOT USED IN ANY PROCEDURE. IT WAS REPORTED THAT THE INITIAL DILATION PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18447565 ↗
• MalfunctionOct 19, 2023Tear, 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 RECEIVED BY THE CUSTOMER ON (B)(6) 2023. PRIOR TO THE PROCEDURE, UPON RECEIVING THE PACKAGE, IT WAS DISCOVERED THAT THE DEVICE PACKAGING WAS PIERCED, AND THE STERILE BARRIER WAS COMPROMISED. A PHOTO OF THE DEVICE PACKAGING WAS SUBMITTED BY THE CUSTOMER AND SHOWED A HOLE IN THE OUTER PACKAGE. THE PRODUCT WAS NOT USED IN A PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967855 ↗
• MalfunctionAug 31, 2023Tear, 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 TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2023. DURING UNPACKING, IT WAS NOTICED THAT THE DEVICE PACKAGING HAD A HOLE. A PHOTO OF THE DEVICE PACKAGING WAS SUBMITTED BY THE CUSTOMER AND SHOWED A NUMBER OF SMALL HOLES IN THE PACKAGING. THE PRODUCT WAS NOT USED IN A PROCEDURE. 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 17661465 ↗
• MalfunctionAug 24, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN PREPARING THE BALLOON FOR ADMISSION, A LEAK IS OBSERVED AT THE TIP, AND THE BALLOON IS PERFORATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO 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 17619044 ↗
• MalfunctionJun 7, 2023Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  NOTE: THIS REPORT PERTAINS TO TWO CRE PRO WIREGUIDED DILATATION BALLOON THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHILE THE PEDIATRIC CONSULTANT AND REGISTRAR PERFORMING GASTROSCOPY, THEY WERE UNABLE TO FEED THROUGH THE DILATATION CATHETER DUE TO A FAULTY TIP. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079823 ↗
• MalfunctionJun 7, 2023Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  NOTE: THIS REPORT PERTAINS TO TWO CRE PRO WIREGUIDED DILATATION BALLOON THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHILE THE PEDIATRIC CONSULTANT AND REGISTRAR PERFORMING GASTROSCOPY, THEY WERE UNABLE TO FEED THROUGH THE DILATATION CATHETER DUE TO A FAULTY TIP. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078862 ↗
• MalfunctionMar 9, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED FOR COLUMNAR BALLOON DILATION OF THE BILE DUCT AND DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), ENDOSCOPIC SPHINCTEROTOMY (EST), AND ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) PROCEDURES PERFORMED ON (B)(6) 2022. DURING DEVICE UNPACKING, THE TIP WAS FOUND TO FORM A CURVATURE AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16518084 ↗
• MalfunctionFeb 6, 2023Burst 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 PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. PRIOR TO PROCEDURE, WHILE INFLATING TO 10MM, THE BALLOON BROKE ON THE DISTAL END. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE 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. 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 PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16304756 ↗
• MalfunctionJan 10, 2023Burst 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 DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON DECEMBER 19, 2022. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO THE RECOMMENDED PRESSURE; HOWEVER, THE BALLOON BURST. THE CUSTOMER STATED THAT NOTHING DETACHED 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 16134112 ↗
• MalfunctionSep 23, 2022Burst 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 COLON DURING A COLONOSCOPY WITH DILATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON WAS SUCCESSFULLY INFLATED TO 8MM AND 9MM, AND WAS ABLE TO BE HELD FOR THE REQUIRED TIME; HOWEVER, WHEN THEY ATTEMPTED TO INFLATE TO 10MM RESISTANCE WAS FELT AND THE BALLOON BURST. 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 15470602 ↗
• MalfunctionJan 12, 2022Burst 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 ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST DURING INITIAL DILATION. 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 13236703 ↗
• MalfunctionNov 29, 2021Burst 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 ESOPHAGUS DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS ABLE TO BE INFLATED TO 8MM AND 9MM WITHOUT ISSUE; HOWEVER, UPON ATTEMPTING TO REACH THE INFLATION TO 10MM, THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 24, 2021 IT WAS REPORTED THAT THE PROCEDURE WAS ALREADY COMPLETED WHEN THE BALLOON BURST AND THE SCOPE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12885330 ↗
• InjuryNov 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON CAME OFF AND THE BALLOON HAD TO BE RETRIEVED FROM THE ESOPHAGUS. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 22, 2021: IT WAS REPORTED THAT THE CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836755 ↗
• MalfunctionMar 15, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A DILATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE DUE TO A PERFORATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11489128 ↗
• MalfunctionFeb 3, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE BALLOON WAS ATTEMPTED TO BE INFLATED IT WAS NOTICED THAT WATER BEGAN SQUIRTING OUT OF A HOLE IN THE BALLOON MATERIAL AND THE BALLOON WAS NOT HOLDING ITS SHAPE. 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 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 11274544 ↗