CRE™ Wireguided and CRE PRO™ Wireguided Balloon Dilation Catheters
Brand(s)
Last updated
Summary
Product
CRE™ Wireguided and CRE PRO™ Wireguided Balloon Dilation Catheters
Issue
Medical devices - Sterility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82136
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