CanadaCRE Wireguided and CRE PRO Wireguided balloon dilation catheters (models M00558660, M00558670, M00558680, M00558690, M00558700 and M00558710), used to endoscopically dilate strictures of the alimentary tract, are affected. They are being removed because of a potential sterile breach of the pouches in which the devices are packaged; contact the manufacturer for additional information.
What's being recalled
Companies: Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752.
How to identify it
Affected products: CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M00558680
Affected products: CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M00558690
Affected products: CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M00558660
Affected products: CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M00558670
Affected products: CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M00558700
Affected products: CRE™ Wire-Guided Esophageal/Pyloric/Biliary Balloon Dilatation Catheter; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: M00558710
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States