- Identify affected devices listed in Medtronic’s field safety notice (FSN) and quarantine those in stock.
- Affected tracheostomy tubes currently in use don’t have to be replaced if no clinical issues have been observed. See FSN for further details.
- Complete and return Medtronic’s returns verification form, even if you don’t have affected product left in stock.
All medical and nursing staff who use these devices or who are responsible for patients with these devices.
Deadlines for actions
Actions underway: 19 August 2015, actions complete: 6 November 2015
This recall affects various Shiley™ Neonatal, pediatric and long pediatric tracheostomy tubes and Cuffless Shiley™ Neonatal, pediatric and long Pediatric tracheostomy tubes with TaperGuard™ Cuff.
See appendix on p 5 & 6 for affected products, lot numbers and NHS supply codes.
Patients may experience breathing difficulties when changing from a current model of Shiley tube to one of the affected earlier models of tube.
Although the specification for the cannula angle on both current and earlier Shiley tubes is the same, the current models have a better fit to patient anatomy due to decreases in manufacturing variability.
This problem when changing tube models mainly affects patients with unique anatomies in their upper airway, head, or neck and who have a mature stoma.
Amanda Woolven, Medtronic
Telephone: 01329 224435
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- A&E departments
- all clinical staff
- ambulance staff
- clinical governance leads
- community children’s nurses
- community hospitals
- ENT departments
- intensive care medical staff/paediatrics
- intensive care nursing staff (paediatric)
- maxillofacial departments
- medical Device Safety Officer (MDSO)
- neonatal nurse specialists
- neonatology departments
- neonatology directors
- nursing executive directors
- paediatric intensive care units
- paediatric nurse specialists
- paediatric surgeons
- paediatric surgery, directors of
- paediatric wards
- resuscitation officers and trainers
- risk managers
- special care baby units
- supplies managers
Liaison officers for onward distribution to all relevant staff including:
- care at home staff
- care management team managers
- children’s disability services
- in-house domiciliary care providers (personal care services in the home)
- in-house residential care homes
Establishments registered with the Care Quality Commission (CQC) (England only)
- domiciliary care providers
- hospitals in the independent sector
- independent treatment centres
- nursing agencies
- private medical practitioners
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2015/030 or 2015/005/019/131/002.
Emma Rooke and Elke Kerwick, MHRA
Telephone: 020 3080 6609/ 6826
Camilla Fleetcroft, MHRA
Telephone: 020 3080 6097
Reporting adverse incidents in England
Alerts in Northern Ireland are distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
Department of Health
Social Services and Public Safety
Telephone: 028 9052 3868
Fax: 028 9052 3900
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Telephone: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Enquiries in Wales should be addressed to:
Healthcare Quality Division
Telephone: 01267 225278 / 02920 825510