Alerts

Recall for product correction - may cause interference with mobile towers

Recall – potential for injury as a result of breakage

Recall - potential for over-delivery of insulin and risk of hypoglycaemia

Hazard alert - potential for reduced device longevity

Safety advisory - potential retention in the brain but no known adverse effects

Recall – risk of cracking or breaking that could affect dosing

TGA urges reporting of issues encountered in high-care settings

Safety advisory - risk of bacterial contamination

Hazard alert – risk of sudden loss of therapy due to reduced battery performance

Hazard alert - increased risk of heart attack and blood clot

Safety alert - Increased rate of major adverse cardiac events observed in patients receiving Bioresorbable Vascular Scaffold (BVS)

Recall – potential failure to activate or need to apply increased force to activate

Hazard alert – potential for under-drainage

Hazard alert - increased risk of requiring revision

Hazard alert - potential for MRI scans to affect valve positioning

Recall – risk of infection due to leakage

Hazard alert - revision rate increasing

Hazard alert - higher than expected rate of PE inlay breakage

Alert - TGA advice regarding potential association with heart failure

Hazard alert - potential for loss of telemetry and pacing due to battery malfunction

Recall for product correction - risk of loss of therapy due to the recharger not functioning

Update - new software update and inclusion of Kora pacemakers

Hazard alert - higher than expected revision rate when used without patella resurfacing

Hazard alert - risk of premature battery depletion

Safety advisory - potential battery issues if compartment cracked