Field Safety Notice Boston Scientific CRETM Wireguided, CRE PROTM, and CRE PRO GITM Balloon Dilation Catheters (ICN 3345)

NHSSC: 14

Alert:

• Boston Scientific has issued Field Safety Notice 97593441-FA recalling CRETM Wireguided, CRE PROTM Wireguided, and CRE PRO GITM Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged.
• These catheters are primarily used to endoscopically dilate strictures of the alimentary tract.
• Boston Scientific advise the issue is highly detectable upon visual inspection of the silver side of the pouch, and the most likely adverse health consequence would be a prolonged procedure due the device being exchanged prior to procedure.

Products Affected:

• 17 products are affected.
• 6 of the products affected are available via NHS Supply Chain.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• Please note only the products and lot numbers quoted in Attachment 1, pages 3, 4 and 5 of the Field Safety Notice are affected.
• Boston Scientific anticipate unaffected devices of 240cm should be available in the next few weeks; in the meantime they suggest using the 180cm devices.
• Where potential alternatives are identified, customers are advised to consult their own clinical experts to ensure suitability for your organisation’s use of these products.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all the affected products / lot numbers.
• Complete the Verification Form, page 6 of the Field Safety Notice whether you have affected products or not and return to Boston Scientific at UK-Quality@bsci.com
• On receipt of the completed form, Boston Scientific will contact you to arrange collection of the affected products.
• Contact your local NHS Supply Customer Services Advisor with full details of the affected products collected by Boston Scientific, including product codes, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number and will raise the appropriate credit.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.