Alerts

Medtronic Australasia has issued a hazard alert regarding two potential issues involving multiple models of its deep brain stimulation and spinal cord stimulation devices.

Medtronic Australasia has issued a hazard alert regarding two potential issues involving its SynchroMed II implantable infusion pump system.

St Jude Medical Australia has issued a hazard alert regarding its Implantable Cardiac Devices (ICDs, including Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)) when reprogrammed with the Merlin Programmer using software version 17.2.2.

Medtronic Australasia has issued a hazard alert for its Mosaic Porcine Aortic Bioprosthesis Model 305 due to the potential for implanting oversized valves.

Owners and people responsible for HeartSine PAD 300/PAD 300P public access defibrillators are advised that Aero Healthcare, in consultation with the TGA, undertook a recall for product correction of some of these devices in November 2012 to correct certain battery and software problems that may affect the ability of the device to work in the event it is needed.

Ausmedic Australia is undertaking a recall for product correction for certain models of Viper and Viper Plus powered wheelchairs

Consumers and health professionals are advised that Hill-Rom, in consultation with the TGA, is undertaking a recall for product correction for the Liko Standard SlingBar 450.

Consumers and health professionals are advised that Mobility Plus, in consultation with the TGA, is undertaking a recall for product correction of Crocodile size 3 walkers.

A hazard alert has been issued to cardiologists and surgeons regarding some models of Cognis Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Teligen Implantable Cardioverter Defibrillators (ICDs).

Stryker Australia, in consultation with the TGA, has issued a hazard alert to surgeons regarding OtisMed ShapeMatch Cutting Guides.

Consumers and health professionals are advised that LMT Surgical is issuing a hazard alert for all sizes and lots of its PyroTitan humeral resurfacing arthroplasty device.

Boston Scientific has initiated a recall for product correction for multiple lots of its Promus Element Plus Monorail everolimus-eluting coronary stent system.

Consumers and health professionals are advised that Novo Nordisk Pharmaceuticals, in consultation with the TGA, has initiated a recall for product correction of certain lots of its NordiPen medical device.

Consumers and health professionals are advised that Stryker Australia, in consultation with the TGA, has issued a hazard alert to surgeons regarding its Oasys Midline Occipital Plate.

Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has initiated a recall for product correction for its Medtronic SynchroMed II and SynchroMed EL implantable infusion pumps.