FDA alerts providers to defibrillator recall due to early battery failure risk

St. Jude Medical has recalled 13 models of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators because the batteries may fail earlier than expected, the Food and Drug Administration reported today. Health care providers should not implant any unused devices, FDA said. Providers and patients also should respond immediately to an Elective Replacement Indicator alert in the affected models, because some batteries have run out within 24 hours of the alert rather than the typical period of three months, the agency said. Among other actions, providers should consider whether elective device replacement is warranted for pacemaker-dependent patients, the agency said. Nearly 350,000 of the devices are actively implanted worldwide.