NHSSC: 64

Alert:

• Boston Scientific has issued a Field Safety Notice recalling specific Lots Direxion™ and HI-FLO™ Microcatheters due to a manufacturing issue that may cause difficulty withdrawing the device from the carrier hoop and difficulty advancing or withdrawing the device through a guide catheter.
• The issue is detectable during device preparation and/or use in the patient and is experienced as increased resistance between the microcatheter and other components.
• This increased resistance, including attempts to advance or withdraw the device when resistance is encountered, may result in damage to the microcatheter.
• Potential adverse health consequences include prolonged procedure, vessel trauma, vasospasm, additional intervention to retrieve a separated device fragment, unretrieved device fragment, thrombosis, or embolism.

Products Affected:

• There are 41 products affected.
• All 41 products affected are available via NHS Supply Chain’s eDirect Service.
• Please see the product listing and Field Safety Notice for full details of the affected products.
• Please note only Lot numbers noted in Attachment 1 of the Field Safety Notice are affected.
• The affected Lots have an expiration date range from 23 October 2027 to 28 July 2028.
• All the affected products are currently subject to intermittent supply.
• There are potential indirect alternatives for some of the products. These products are available to order through our online catalogue.
• See our Downloads▼ section to access the product listing and Field Safety Notice for more information on the affected products and potential alternatives.
• Where potential alternatives are identified, Customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.
• See our Useful Links to view ICN 3488 for the latest information on the supply disruption. The supply issue is anticipated to be resolved by the end of November 2026.

Next Steps:

• Customers are advised to log into our website to view the product listing for further information on the affected product codes and potential alternatives.

• 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 affected Lot numbers.
• Complete the Customer Response Form, found page 10 of the Field Safety Notice, and by emailing: UK-Quality@bsci.com.
• On receipt of the completed form, the supplier will arrange to collect the affected products.
• Please also contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products for return to Medicare Colgate, including National Product Code (NPC), Lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number and raise your credit as appropriate.

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.