CRE WireguidedRecalls & reported problems across all models
Boston Scientific Corporation · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one CRE Wireguided model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 358
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 6
We found 12 models of CRE Wireguided by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 358 adverse event reports in the FDA's MAUDE database, received between Nov 7, 2017 and Sep 28, 2026 — classified as 4 injuries, 354 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (143 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 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. 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
CRE Wireguided recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 21, 2026Open, Classified
Potential sterile breach of the pouches in which devices are packaged.
Z-2637-2026 · Root cause: Package design/selection · Recall details · FDA record ↗
- May 21, 2026Open, Classified
Potential sterile breach of the pouches in which devices are packaged.
Z-2636-2026 · Root cause: Package design/selection · Recall details · FDA record ↗
- May 21, 2026Open, Classified
Potential sterile breach of the pouches in which devices are packaged.
Z-2635-2026 · Root cause: Package design/selection · Recall details · FDA record ↗
- May 21, 2026Open, Classified
Potential sterile breach of the pouches in which devices are packaged.
Z-2634-2026 · Root cause: Package design/selection · Recall details · FDA record ↗
- May 21, 2026Open, Classified
Potential sterile breach of the pouches in which devices are packaged.
Z-2633-2026 · Root cause: Package design/selection · Recall details · FDA record ↗
- May 21, 2026Open, Classified
Potential sterile breach of the pouches in which devices are packaged.
Z-2632-2026 · Root cause: Package design/selection · Recall details · FDA record ↗
Most reported CRE Wireguided problems
Device problems
- Burst Container or Vessel143
- Material Puncture/Hole123
- Leak/Splash62
- Inflation Problem37
- Use of Device Problem33
- Adverse Event Without Identified Device or Use Problem16
- Tear, Rip or Hole in Device Packaging15
- Material Deformation8
Patient problems
- No Clinical Signs, Symptoms or Conditions231
- No Consequences Or Impact To Patient118
- Insufficient Information3
- No Patient Involvement3
- No Known Impact Or Consequence To Patient2
- Anxiety1
- Discomfort1
- Nausea1
CRE Wireguided models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CRE Wireguided M00558500Dilator, esophageal1 recall58 reports
- CRE Wireguided M00558490Colonoscope and accessories, flexible/rigid1 recall46 reports
- CRE Wireguided M00558480Dilator, esophageal1 recall36 reports
- CRE Wireguided M00558470duodenoscope and accessories, flexible/rigid1 recall17 reports
- CRE Wireguided M00558460duodenoscope and accessories, flexible/rigid1 recall11 reports
- CRE Wireguided M00558450Colonoscope and accessories, flexible/rigid1 recall4 reports
- CRE Wireguided M00558400Colonoscope and accessories, flexible/rigid45 reports
- CRE Wireguided M00558410Dilator, esophageal39 reports
- CRE Wireguided M00558420Colonoscope and accessories, flexible/rigid36 reports
- CRE Wireguided M00558440duodenoscope and accessories, flexible/rigid36 reports
- CRE Wireguided M00558390Colonoscope and accessories, flexible/rigid20 reports
- CRE Wireguided M00558430Dilator, esophageal10 reports
Recent CRE Wireguided adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Deflate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925875 ↗MalfunctionSep 23, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873587 ↗MalfunctionSep 22, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859404 ↗MalfunctionSep 22, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859403 ↗MalfunctionSep 22, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859317 ↗MalfunctionSep 22, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859316 ↗MalfunctionSep 22, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859313 ↗MalfunctionSep 15, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765971 ↗MalfunctionSep 15, 2026Burst Container or Vessel; Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765921 ↗MalfunctionSep 11, 2026Burst Container or Vessel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744519 ↗MalfunctionSep 11, 2026Burst Container or Vessel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744485 ↗MalfunctionSep 9, 2026Burst Container or Vessel; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700515 ↗MalfunctionSep 3, 2026Inflation Problem; Leak/Splash; Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599745 ↗MalfunctionSep 3, 2026Inflation Problem; Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599508 ↗MalfunctionAug 13, 2026Burst Container or Vessel; Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50240175 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page