Consent decree for medical devices supplied by Atrium Medical (Maquet)
- Medicines and Healthcare products Regulatory Agency
- 20 February 2015
- 20 February 2015
- Alert type:
- Medical device alert
(Atrium Medical subsidiary of Maquet) Guidance for healthcare professionals who have received a Food and Drug Administration (FDA) consent decree from Maquet about its subsidiary Atrium Medical. (MDA/2015/006)
- be aware that Atrium Medical (Maquet) is likely to contact you about the consent decree before you can purchase further devices
- review the medical need for continued use of the devices listed in the consent decree including the availability of suitable alternatives
- if you need to purchase further devices, sign the Certificate of Medical Necessity and return to Maquet
- be aware that a Certificate of Medical Necessity is not required for existing hospital stock
Staff who use and purchase these devices
Actions underway: 27 February 2015, actions completed: 13 March 2015.
All models and lots of specific Atrium products including:
- stents (Advanta V12)
- local therapeutic infusion catheters (ClearWay RX/OTW)
- chest drains (Ocean/Oasis/Express)
The Food and Drug Administration (FDA), the USA regulator, has identified problems with quality management systems at Maquet and their subsidiaries (including Atrium Medical). Further information can be found on the FDA website. A consent decree has been issued, which prevents one of the USA-based sites from distributing devices.
The FDA’s consent decree requires that Atrium Medical’s (Maquet) customers sign a Certificate of Medical Necessity to allow the company to continue the supply of medical devices listed above.
The status of other medical devices sold by Atrium Medical (Maquet) is available in Atrium Medical’s Notification Guide.
Although the devices listed in the consent decree are CE marked and can be legally sold in the UK, you may be asked to sign a Certificate of Medical Necessity by the manufacturer.
Hari Rajendran, Regulatory Affairs Officer
Maquet UK Ltd
14-15 Burford Way
Boldon Business Park
NE35 9PZ, UK
Telephone: 0191 519 6200
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- cardiology departments
- cardiology, directors of
- cardiothoracic departments
- cardiothoracic surgeons
- cardiothoracic surgery directors
- clinical governance leads
- day surgery units
- general surgeons
- general surgery
- general surgical units, directors of
- medical directors
- medical libraries
- paediatric medicine, directors of
- paediatric surgeons
- paediatric surgery, directors of
- paediatric wards
- paediatrics departments
- purchasing managers
- risk managers
- supplies managers
- theatre managers
Establishments registered with the Care Quality Commission (CQC) (England only):
- hospitals in the independent sector
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.
If you are in England send enquiries about this notice to MHRA, quoting reference number MDA/2014/006 or 2015/002/011/081/017.
Louise Mulroy or Annie Dhillon, MHRA
Telepehone: 020 3080 7344 or 6886
Mark Grumbridge, MHRA
Telephone: 020 3080 7128
Reporting adverse incidents in England
Through Yellow Card
Alerts in Northern Ireland are distributed via the NI SABS system.
Address enquiries and adverse incident reports in Northern Ireland to:
Northern Ireland Adverse Incident Centre, CMO Group
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Fax: 028 9052 3900
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Tel: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS Boards and local authorities in Scotland should report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients should also report to Health Facilities Scotland.
Enquiries in Wales should be addressed to:
Healthcare Quality Division, Welsh Government
Tel: 01267 225278 / 02920 825510
Reporting adverse incidents in Wales
Published: 20 February 2015
Issued: 20 February 2015
Alert type: Medical device alert