CRE™ Wireguided and CRE PRO™ Wireguided Balloon Dilation Catheters
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter |
More than 10 numbers, contact manufacturer. |
M00558680 |
CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter |
More than 10 numbers, contact manufacturer. |
M00558690 |
CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter |
More than 10 numbers, contact manufacturer. |
M00558660 |
CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter |
More than 10 numbers, contact manufacturer. |
M00558670 |
CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter |
More than 10 numbers, contact manufacturer. |
M00558700 |
CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter |
More than 10 numbers, contact manufacturer. |
M00558710 |
Issue
Boston Scientific is initiating removal of CRE™ Wireguided and CRE PRO™ Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged. These catheter products are primarily used to endoscopically dilate strictures of the alimentary tract.
Additional information
Details
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
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