CRE Fixed Wire M00558380Recalls & reported problems
Boston Scientific Corporation · Esophageal Balloon Dilatation Catheter · Class 2
Quick summary
This Boston Scientific CRE Fixed Wire balloon, used to widen the esophagus, has 349 adverse event reports on file, with no deaths and 8 injuries. Reports mostly describe the balloon bursting, not deflating fully, or being hard to pull out of the scope, and a few mention tears or bleeding. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 359
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 359 adverse event reports that list this exact device (DI 08714729202011), received between May 24, 2017 and Sep 14, 2026 — classified as 8 injuries, 351 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (206 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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel206
- Failure to Deflate50
- Deflation Problem36
- Material Puncture/Hole32
- Adverse Event Without Identified Device or Use Problem30
- Difficult to Remove16
- Leak/Splash16
- Use of Device Problem15
Patient problems
- No Clinical Signs, Symptoms or Conditions267
- No Consequences Or Impact To Patient76
- No Known Impact Or Consequence To Patient8
- Insufficient Information5
- Hemorrhage/Blood Loss/Bleeding3
- Laceration(s)3
- Aspiration/Inhalation1
- Chest Pain1
Recent adverse event reports
The 25 most recent of 359 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Burst Container or Vessel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764087 ↗MalfunctionSep 14, 2026Failure to Deflate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755619 ↗MalfunctionSep 14, 2026Failure to Deflate
It was reported to Boston Scientific Corporation that a CRE Fixed Wire Dilatation Balloon was used in the esophagus during a Dilation procedure to treat stricture performed on (b)(6) 2026. During the procedure, the dilatation balloon would not deflate after dilation. The gastroscope was withdrawn with the balloon remaining partially inflated. Once removed from the patient, the balloon was cut to facilitate separation of the dilator from the gastroscope. The procedure was prolonged by approximately 5 to 10 minutes due to the need for device exchange and reinsertion of the gastroscope. The procedure was completed using the original device. There were no patient complications reported as a result of this event and the patient condition following procedure was reported to be fine.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755612 ↗MalfunctionSep 14, 2026Failure to Deflate
It was reported to Boston Scientific Corporation that a CRE Fixed Wire Dilatation Balloon was used in the esophagus during a Dilation procedure to treat stricture performed on (b)(6) 2026. During the procedure, the dilatation balloon would not deflate after dilation. The gastroscope was withdrawn with the balloon remaining partially inflated. Once removed from the patient, the balloon was cut to facilitate separation of the dilator from the gastroscope. The procedure was prolonged by approximately 5 to 10 minutes due to the need for device exchange and reinsertion of the gastroscope. The procedure was completed using the original device. There were no patient complications reported as a result of this event and the patient condition following procedure was reported to be fine.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755611 ↗MalfunctionSep 14, 2026Failure to Deflate
It was reported to Boston Scientific Corporation that a CRE Fixed Wire Dilatation Balloon was used in the esophagus during a Dilation procedure to treat stricture performed on (b)(6)2026. During the procedure, the dilatation balloon would not deflate after dilation. The gastroscope was withdrawn with the balloon remaining partially inflated. Once removed from the patient, the balloon was cut to facilitate separation of the dilator from the gastroscope. The procedure was prolonged by approximately 5 to 10 minutes due to the need for device exchange and reinsertion of the gastroscope. The procedure was completed using the original device. There were no patient complications reported as a result of this event and the patient condition following procedure was reported to be fine.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755610 ↗MalfunctionSep 14, 2026Failure to Deflate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755609 ↗MalfunctionSep 14, 2026Burst Container or Vessel; Inflation Problem; Use of Device Problem
It was reported to Boston Scientific Corporation that a CRE Fixed Wire Dilatation Balloon was used in the pyloric channel during an Esophagogastroduodenoscopy (EGD) Dilation procedure to treat stenosis performed on (b)(6) 2026.During the procedure, the balloon burst when inflated. It was reported that no piece of the balloon detaches inside the patient. Additionally, the balloon was overinflated by the user. The procedure was completed with the original device. There were no patient complications reported as a result of this event and patient's condition at the conclusion of the procedure was reported to be stable.Note: It was reported that the balloon was overinflated. Per the Instruction for Use (IFU), it was indicated not to exceed the inflation pressure corresponding to the maximum balloon diameter indicated on the catheter hub and package label.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754604 ↗MalfunctionSep 5, 2026Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50625621 ↗MalfunctionSep 3, 2026Inflation Problem; Leak/Splash; Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599651 ↗MalfunctionAug 31, 2026Burst Container or Vessel
It was reported to Boston Scientific Corporation that a CRE Fixed Wire Dilatation Balloon was attempted to be used during an Esophagogastroduodenoscopy (EGD) procedure performed on (b)(6) 2026.During the procedure, it was reported that the balloon popped before being fully inflated. The procedure outcome remains unknown despite good faith efforts. 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 50533773 ↗MalfunctionAug 21, 2026Failure to Deflate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50374607 ↗MalfunctionAug 14, 2026Material Puncture/Hole
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) 2026.During the procedure, the balloon leaked and a pinhole was noticed. The procedure was completed with another CRE Fixed Wire Dilatation Balloon.There were no patient complications reported as a result of this event. The patients condition at the conclusion of the procedure was reported to be stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256063 ↗MalfunctionAug 14, 2026Adverse Event Without Identified Device or Use Problem; Failure to Deflate
It was reported to Boston Scientific Corporation that a CRE Fixed Wire Dilatation Balloon was used during an Upper Endoscopy procedure performed on (b)(6) 2026.It was reported that after dilation, the balloon would not deflate all way down to remove the balloon from the endoscope. 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 50255895 ↗MalfunctionAug 13, 2026Use of Device Problem; Failure to Deflate
It was reported to Boston Scientific Corporation that a CRE Fixed Wire Dilatation Balloon was used in the esophagus during an Alimentary Dilation procedure to treat stricture performed on (b)(6) 2026.During the procedure, it was reported that CRE Balloon was not draining and needed to be cut off to get out of scope. The procedure was completed using 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 50237355 ↗MalfunctionAug 3, 2026Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50112124 ↗MalfunctionJul 31, 2026Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Failure to Deflate
It was reported to Boston Scientific Corporation that a CRE Fixed Wire Dilatation Balloon was used during an Esophagogastroduodenoscopy (EGD) procedure to treat stricture performed on (b)(6) 2026.During the procedure, the balloon would not deflate completely. The scope and balloon were removed as one from patient and had to cut the catheter. The procedure was still completed with the same original device. There were no patient complications as a result of this event and the patient's condition was reported to be fully recovered.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105589 ↗MalfunctionJul 13, 2026Burst 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 ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION PROCEDURE FOR STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON BURST AFTER DEVICE REACHED A DIAMETER OF 20MM. NO PIECE OF 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. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25807894 ↗MalfunctionJul 9, 2026Burst 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 ESOPHAGEAL DILATION PROCEDURE FOR STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON POPPED DURING DILATION. NO PIECE OF 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. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25773148 ↗MalfunctionJul 7, 2026Burst Container or Vessel; Use of Device Problem; 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 ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE REPORTEDLY EXPLODED AT 18-19 ATM. AS A RESULT OF THE EVENT, THE PATIENT SUSTAINED A SMALL ESOPHAGEAL TEAR. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS REPORTED TO BE OKAY. 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: Laceration(s)
MAUDE report 25741922 ↗MalfunctionJul 3, 2026Use of Device Problem; Failure to Deflate
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN UPPER ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, DILATION WAS COMPLETED SUCCESSFULLY. HOWEVER, DIFFICULTY WAS ENCOUNTERED DURING BALLOON DEFLATION FOLLOWING THE PROCEDURE. THE WIRE WAS CUT TO ALLOW REMOVAL OF THE BALLOON FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25704828 ↗MalfunctionJun 30, 2026Use of Device Problem; Failure to Deflate
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN UPPER ENDOSCOPY PROCEDURE FOR DILATION PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE DID NOT FULLY DEFLATE AS INTENDED. TO FACILITATE REMOVAL, THE WIRE WAS CUT, WHICH ALLOWED COMPLETE DEFLATION OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673500 ↗MalfunctionJun 25, 2026Inflation Problem; Material Puncture/Hole
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) WITH DILATION PROCEDURE TO TREAT ESOPHAGEAL STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON DID NOT STAY INFLATED AND HAD HOLES WHEN TRIED TO INFLATE IT. THE PROCEDURE WAS COMPLETED USING ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25622740 ↗MalfunctionJun 17, 2026Burst 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 TO TREAT DISPHASIA PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON BURST UPON INFLATION. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540719 ↗MalfunctionJun 17, 2026Burst 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 TO TREAT ESOPHAGITIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON BURST WHILE INFLATING AT 20 MM. IT WAS REPORTED THAT NO PART OF THE BALLOON WAS DETACHED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534448 ↗MalfunctionJun 16, 2026Burst 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 FOR DYSPHASIA PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON BURST AFTER REACHING A DIAMETER OF 20MM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PIECE OF BALLOON DETACHED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25524941 ↗
Other Dilator, esophageal devices
- CRE Fixed Wire M00558370Boston Scientific Corporation · Dilator, esophageal219 reports
- XXL™ Esophageal M001145590Boston Scientific Corporation · Dilator, esophageal116 reports
- Olympus BD-400P-2080Gyrus ACMI, LLC · Dilator, esophageal1 recall60 reports
- CRE Wireguided M00558500Boston Scientific Corporation · Dilator, esophageal1 recall58 reports
- Olympus BD-400P-1580Gyrus ACMI, LLC · Dilator, esophageal2 recalls4 reports
- XXL™ Esophageal M001145520Boston Scientific Corporation · Dilator, esophageal102 reports
- EZDilate BD-410X-1055Gyrus ACMI, LLC · Dilator, esophageal2 recalls0 reports
- CRE Fixed Wire M00558360Boston Scientific Corporation · Dilator, esophageal93 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.