Medical Device Alerts

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 MDAs remain valid unless they are updated or withdrawn.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

• 01 Feb 2012 | Medical Device Alert: Catheter valve manufactured by Coloplast (MDA/2012/003)
  

  This Medical Device Alert has been issued as Coloplast are recalling this product due to a sterility issue associated with the catheter valve.

• 18 Jan 2012 | Medical Device Alert: Tracheostomy tubes: Bivona® Neonatal, Pediatric and Flextend manufactured by Smiths Medical (MDA/2012/002)
  

  This Medical Device Alert has been issued as incorrectly connected accessories may be difficult to remove, requiring excessive force to disconnect.  This may cause the tube to dislodge, requiring it to be changed.

• 17 Jan 2012 | Medical Device Alert: Rüsch Flexislip/Flexi-Slip™ endotracheal tube stylet with soft distal tip, 6F manufactured by Teleflex (MDA/2012/001)
  

  This Medical Device Alert has been issued as Teleflex is undertaking a recall following complaints received about two problems - difficulty removing the stylet from the endotracheal tube after intubation and separation of the PVC sheath from the stylet.

• 05 Jan 2012 | Monthly list of MDAs - 2011
  

  A month-by-month list of Medical Device Alerts that we have issued in 2011.

• 22 Dec 2011 | Medical Device Alert: Octopus 3 extension set with anti-reflux valves and clamps manufactured by Vygon (MDA/2011/113)
  

  This Medical Device Alert has been issued as there is a possible failure to deliver therapy under gravity infusion, as these sets may be fitted with anti-syphon valves instead of anti-reflux valves.

• 22 Dec 2011 | Medical Device Alert: Implantable cardioverter defibrillator (ICD) leads manufactured by St Jude Medical (MDA/2011/112)
  

  This Medical Device Alert has been issued as there is a risk of inappropriate therapy due to wear and/or abrasion of lead insulation after implantation when using Implantable cardioverter defibrillator (ICD) leads manufactured by St Jude Medical.

• 21 Dec 2011 | Medical Device Alert: Specific model variants of Plum A+ infusion pumps manufactured by Hospira Inc - (MDA/2011/111)
  

  This Medical Device Alert has been issued as there is the risk of over infusion of medication due to failure of the flow regulator when using Plum A+ infusion pumps manufactured by Hospira Inc.

• 13 Dec 2011 | Medical Device Alert: All Plum A+ infusion pumps manufactured by Hospira Inc (MDA/2011/110)
  

  This Medical Device Alert has been issued due to a possible delay in therapy due to continuous recycling and/or rebooting, if the LED display settings are adjusted from the original default settings when using Plum A+ infusion pumps manufactured by Hospira Inc.

• 09 Dec 2011 | Medical Device Alert: ProcedurePaks manufactured by Molnlycke Health Care (MDA/2011/109)
  

  This Medical Device Alert has been issued as ProcedurePaks with devices containing latex have been incorrectly labelled as latex-free.

• 01 Dec 2011 | Medical Device Alert: Anaesthetic machine: Auxiliary Common Gas Outlet (ACGO) manufactured by GE Healthcare (MDA/2011/108)
  

  This Medical Device Alert has been issued as the accidental incorrect setting of the ACGO switch will result in no fresh gas flow to the patient.