CRE Fixed WireRecalls & reported problems across all models
Boston Scientific Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 738
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 6 models of CRE Fixed Wire by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 738 adverse event reports in the FDA's MAUDE database, received between May 24, 2017 and Sep 21, 2026 — classified as 18 injuries, 720 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (417 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CRE Fixed Wire problems
Device problems
- Burst Container or Vessel417
- Failure to Deflate83
- Material Puncture/Hole73
- Deflation Problem63
- Adverse Event Without Identified Device or Use Problem50
- Leak/Splash41
- Difficult to Remove33
- Use of Device Problem33
Patient problems
- No Clinical Signs, Symptoms or Conditions516
- No Consequences Or Impact To Patient185
- No Known Impact Or Consequence To Patient13
- Insufficient Information10
- Hemorrhage/Blood Loss/Bleeding5
- Laceration(s)4
- Unspecified Tissue Injury4
- Aspiration/Inhalation2
CRE Fixed Wire models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CRE Fixed Wire M00558380Dilator, esophageal359 reports
- CRE Fixed Wire M00558370Dilator, esophageal219 reports
- CRE Fixed Wire M00558360Dilator, esophageal93 reports
- CRE Fixed Wire M00558350Dilator, esophageal39 reports
- CRE Fixed Wire M00558340Dilator, esophageal18 reports
- CRE Fixed Wire M00558330Dilator, esophageal10 reports
Recent CRE Fixed Wire adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Failure to Deflate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846422 ↗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 25, 2026Difficult to Remove; Material Twisted/Bent; 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 a Gastrointestinal Dilation procedure performed on (b)(6) 2026.During device removal following the completion of the procedure, the deflated balloon catheter became lodged at the distal end of the endoscope working channel and could not be withdrawn through the channel. The procedure was completed by removing the endoscope and balloon together. Subsequent bench testing was unable to remove the balloon from the endoscope. Upon inspection, the distal tip was bent and twisted. The procedure was completed with the original device. There were no patient complications reported as a result of this event and the patient condition following procedure was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50425855 ↗MalfunctionAug 21, 2026Difficult to Remove; Deformation Due to Compressive Stress; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50376412 ↗MalfunctionAug 21, 2026Failure to Deflate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50374607 ↗MalfunctionAug 20, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50360035 ↗
Other Boston Scientific Corporation products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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