22 June 09 MDA(NI)2009/041 (PDF34KB) Locomotor lifting slings for adults and children manufactured by Select Healthcare (UK) Ltd. Potential for straps to detach in use ifsafety-critical stitching is missing. This can cause the occupant to fall from the sling with the potential for serious injury or death.
18 June 09 MDA(NI)2009/040 (PDF 374KB) Heliosphere Bag® Intragastric Balloon manufactured by Helioscopie Medical Implants and distributed in the UK by UK Surgical. Affected batches supplied in the UK: 08IN328-8 and 08IN328-10. Possible bowel obstruction due to full or partial early deflation of the balloon during the intended six months implantation period caused by a manufacturing welding problem.
16 June 09 MDA(NI)2009/039 (PDF33.5KB) Prelude Short Sheath Introducer manufactured by Merit Medical. All batches of specific models affected. The sidearm tubing may detach from the sheath during use, which may result in excessive blood loss and potential bloodborne pathogen exposure to those in the surrounding area.
10 June 09 MDA(NI)2009/038 (PDF36KB) Implantable pacemakers. Medtronic Kappa® 600/700/900 series and Sigma® 100/200/300 series IPGs. Specific serial numbers may be entered online to determine if they are affected(http://KappaSigmaSNList.medtronic.com). Certain Kappa® and Sigma® series pacemakers may suffer sudden unexpected failure giving rise to bradycardia symptoms (fainting or light headedness). Serious injury or death may occur in pacemaker dependent patients.
4 June 09 MDA(NI)2009/037 (PDF29.6KB) Knee replacement implant. Preservation mobile bearing unicompartmental knee manufactured by DePuy International Limited. Revision rate higher than expected.
2 June 2009 MDA(NI)2009/036 (PDF30.2) Intravenous burette administration set manufactured by Codan. Product code 593310. Batch numbers F74916-1 and F74916-2 only. NHS Supply Chain code FSB003 (England only). The manufacturer has identified the potential for leakage from the drip chamber of certain burette sets. This could result in inadequate intravenous administration.
