CRE PRORecalls & 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 PRO model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 891
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 6
We found 12 models of CRE PRO by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 891 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2017 and Sep 30, 2026 — classified as 20 injuries, 871 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (340 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 PRO 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-2631-2026 · 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-2630-2026 · 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-2629-2026 · 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-2628-2026 · 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-2627-2026 · 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-2626-2026 · Root cause: Package design/selection · Recall details · FDA record ↗
Most reported CRE PRO problems
Device problems
- Burst Container or Vessel340
- Material Puncture/Hole300
- Leak/Splash142
- Inflation Problem90
- Adverse Event Without Identified Device or Use Problem71
- Tear, Rip or Hole in Device Packaging53
- Use of Device Problem40
- Material Split, Cut or Torn29
Patient problems
- No Clinical Signs, Symptoms or Conditions692
- No Consequences Or Impact To Patient160
- No Known Impact Or Consequence To Patient17
- No Patient Involvement15
- Insufficient Information7
- Hemorrhage/Blood Loss/Bleeding6
- Perforation4
- Respiratory Insufficiency2
CRE PRO models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CRE™ PRO M00558710CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- CRE™ PRO M00558700CATHETER, BILIARY, DIAGNOSTIC1 recall139 reports
- CRE™ PRO M00558690CATHETER, BILIARY, DIAGNOSTIC1 recall115 reports
- CRE™ PRO M00558680CATHETER, BILIARY, DIAGNOSTIC1 recall60 reports
- CRE™ PRO M00558670CATHETER, BILIARY, DIAGNOSTIC1 recall31 reports
- CRE™ PRO M00558660CATHETER, BILIARY, DIAGNOSTIC1 recall14 reports
- CRE™ PRO M00558650CATHETER, BILIARY, DIAGNOSTIC59 reports
- CRE™ PRO M00558610CATHETER, BILIARY, DIAGNOSTIC52 reports
- CRE™ PRO M00558620CATHETER, BILIARY, DIAGNOSTIC38 reports
- CRE™ PRO M00558600CATHETER, BILIARY, DIAGNOSTIC34 reports
- CRE™ PRO M00558630CATHETER, BILIARY, DIAGNOSTIC34 reports
- CRE™ PRO M00558640CATHETER, BILIARY, DIAGNOSTIC31 reports
Recent CRE PRO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Burst Container or Vessel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953785 ↗MalfunctionSep 29, 2026Inflation Problem; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940192 ↗MalfunctionSep 24, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876560 ↗MalfunctionSep 23, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876368 ↗MalfunctionSep 22, 2026Inflation Problem; Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862791 ↗MalfunctionSep 22, 2026Inflation Problem; Leak/Splash
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, it was reported that the customer was unable to inflate the balloon as there was fluid coming out and was leaking. The procedure was completed with another of the same device. The anatomy location of the procedure is unknown and is being reported as the balloon leak may have occurred in the esophagus.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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855057 ↗MalfunctionSep 22, 2026Inflation Problem; Leak/Splash
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, it was reported that the customer was unable to inflate the ballon as there was fluid coming out and was leaking. The procedure was completed with another of the same device. The anatomy location of the procedure is unknown and is being reported as the balloon leak may have occurred in the esophagus.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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849680 ↗MalfunctionSep 17, 2026Tear, Rip or Hole in Device Packaging
It was reported to Boston Scientific Corporation that a CRE PRO Wireguided DASE Dilatation Balloon was attempted to be used during a procedure performed on (b)(6) 2026.Prior to the procedure, indents were noted on the device pouch, resulting in a sterile barrier breach.There were no patient complications reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797731 ↗MalfunctionSep 15, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779382 ↗MalfunctionSep 15, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779378 ↗MalfunctionSep 5, 2026Burst Container or Vessel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50626422 ↗MalfunctionSep 5, 2026Burst Container or Vessel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50626421 ↗MalfunctionSep 2, 2026Burst Container or Vessel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575973 ↗MalfunctionSep 1, 2026Burst Container or Vessel; Difficult to Advance
It was reported to Boston Scientific Corporation (BSC) that a CRE PRO Wireguided DASE Dilatation Balloon was attempted to be used in the esophagus during an esophageal stricture procedure performed on (b)(6) 2026.During the procedure, resistance was encountered when threading the balloon through the working channel of the scope. Upon inflation with the syringe assembly, the balloon burst inside the patients esophagus. The customer stated that no pieces of the balloon detached inside the patient. The procedure was completed with another CRE PRO Wireguided DASE Dilatation Balloon of a different lot number and a non-BSC inflation 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 stable.Additional Information received 03 SEP 2026.Patient was having an Esophagogastroduodenoscopy (EGD) Dilation and a CRE Pro Wireguided dilator measurements 18-20mm was used. Instrument appeared intact, all checks completed. The balloon was inflated as normal, but the balloon burst while in the patient's esophagus at the max pressure. No injury to the patient, however, a new instrument had to be used d
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550084 ↗MalfunctionAug 21, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50364913 ↗
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.
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