Alerts

Update - new hazard alert with updated revision rates

Recall - may break during use

Recall - potential decreased sensitivity and risk of false negative results

Recall for product correction - potential for audible alarms not sounding

Hazard alert - potential for premature replacement alert

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

Recall - small risk of infection due to potential contamination

Recall for product correction – potential for leakage and/or breakage

Hazard alert - risk of soft tissue irritation and potential need for revision

Hazard alert - potential battery issues

Hazard alert - potential for loss of therapy due to lead insulation damage

Hazard alert - risk of liver abscess

Hazard alert - higher-than-expected revision rate

Recall - potential for user injury as a result of device breakage

Recall for product correction – potential for user injury

Hazard alert - potential for post-operative infection

Hazard alert - higher than expected revision rates

Hazard alert update - additional issue that can result in an unintended device software reset

Hazard alert - potential for component failure due to metal fracture

Hazard alert - risk of implant breakage that could cause adverse events and require additional surgery

Recall for product correction - potential for interruption of insulin delivery and/or infection due to needle breaking during use

Hazard alert - warnings regarding potential adverse events

Recall for product correction - potential for interruption of medicine delivery and/or infection due to needle breaking during use

Recall for product correction - potential for interruption of insulin delivery and/or infection due to needle breaking during use

Recall for product correction - increased risk of death for patients with symptomatic chronic heart failure