Field Safety Notice Medtronic SenSight ™ Extension Tunneller Kit Product Recall (ICN 2133)

Alert:

• Medtronic has issued a Field Safety Notice recalling a range of Lot numbers following reports of the SenSight™ Extension Tunneller kit that contains dual carriers have been machined on one side only.
• As a result of this issue, the dual carrier cannot be used to pass two extensions simultaneously. The surgical procedure may be delayed obtaining another dual carrier or an additional tunnelling pass may be necessary to complete the implant of two extensions.
• This issue only affects the dual carrier; the remaining components in the kit are unaffected.

Products Affected:

•  The product affected is available from NHS Supply Chain:

• Please see Attachment A: Identifying Affected Products on Page 3 of the Field Safety Notice for details of the affected lot numbers.

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 the affected devices.
• Complete and return the customer acknowledgement form, even if you have no stock, as soon as possible to: regulatoryuk-ire@medtronic.com Medtronic will facilitate the collection and/or replacement of devices.
• If you have any questions regarding this communication, please contact your Medtronic representative directly or via Tel No: 01923 212213
• Where potential alternatives are identified, Customers are requested to consult alternative options with their own clinical specialists /experts to ensure clinical suitability for your care delivery requirements
• Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible persons and distributors 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.

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