Medical Device Alerts (MDAs) were introduced on 1 January 2003, to replace the previous types of safety warnings (Hazard notice, Safety notice, Device alert, Advice notice and Pacemaker technical note) which can be found under Publications > Safety warnings.
MDAs are distributed to the NHS in England via the Department of Health's Central Alerting System (CAS). MDAs remain valid unless they are updated or withdrawn. They are reviewed once they are five years old (and subsequently every year) and the lists on this website are amended accordingly.
Latest Medical Device Alerts
09 Oct 2014 | Medical Device Alert: LIFEPAK® 1000 defibrillator manufactured by Physio-Control (MDA/2014/040)
This Medical Device Alert is being issued as there is a risk of failure to deliver a shock.
07 Oct 2014 | Medical Device Alert: TELIGEN implantable cardioverter defibrillators (ICD) and COGNIS cardiac resynchronisation therapy devices (CRT-D) manufactured by Boston Scientific (MDA/2014/039)
This medical device alert has been issued due to a risk of loss of therapy due to rapid battery depletion. Additional serial numbers of devices are affected since the manufacturer’s original notification in August 2013.
01 Oct 2014 | Medical Device Alerts - monthly lists and yearly reviews
A month-by-month list of MDAs that we have issued in 2014, and lists of archived MDAs.
30 Sep 2014 | Medical Device Alert: Neonatal and paediatric support devices: Gel-E Donut and Squishon 2, various part numbers, all batches, manufactured by Philips Healthcare (Children’s Medical Ventures) (MDA/2014/038)
This medical device alert is being issued due to risk of infection, breathing difficulties and allergic reactions caused by mould growth on the devices.
26 Sep 2014 | Medical Device Alert: All medical devices (MDA/2014/037)
This medical device alert is being issued due to delays in acting on Field Safety Notices (FSNs).
17 Sep 2014 | Medical Device Alert: Portex® endotracheal tube holder (2.5mm and 3.0mm) manufactured by Smiths Medical (MDA/2014/036)
This medical device alert is being issued due to the risk of extubation or delay to therapy as there may be difficulty passing a suction catheter through the endotracheal tube when the holder is locked.
16 Sep 2014 | Medical Device Alert: Ellipse™ VR/DR implantable cardioverter defibrillators manufactured by St Jude Medical (MDA/2014/035)
This medical device alert is being issued due to a potential failure mode which can delay or reduce the therapy that can be delivered by the ICD.
27 Aug 2014 | Medical Device Alert: Basin/bowl liner or equipment cover (drape) manufactured by Microtek Medical (MDA/2014/034)
This medical device alert is being issued due to the risk of some of the devices within the highlighted product codes having small cracks or holes. This could compromise the sterile field.
20 Aug 2014 | Medical Device Alert: Insulin syringe 1ml safety syringe 27G (for professional use) manufactured by Medicina Ltd (MDA/2014/033)
This MDA is being issued due to affected devices unable to deliver fewer than 7 units of insulin. In addition, the safety and performance of these devices has not been properly evaluated and so the CE marking of all of these devices is invalid.
This medical device alert is being issued due to the risk of infection as the balloon gastrostomy kit may contain out-of-date devices. In addition, the safety and performance of these devices has not been properly evaluated and so the CE marking is invalid.