FDA MAY RECALL ST. JUDE DEFIBRILLATORS
The FDA may issue a recall of older St. Jude Medical implantable cardioverter defibrillators (ICDs) after the company reported that background levels of radiation in the atmosphere might cause the devices to suddenly lose power.
St. Jude Medical recently announced that in 60 of the 36,000 Photon DR, Photon Micro VR/DR and Atlas VR/DR devices, exposure to cosmic radiation affected the ICD's memory. But the company said that no serious patient injuries or deaths have been reported because of the flaw.
In its recent physician advisory, St. Jude Medical recommended that doctors should perform routine device monitoring every three months for patients with these ICDs. The company is also offering a remote monitoring product, Housecall Plus, at no charge. "St. Jude Medical has taken a conservative, proactive approach in notifying the medical community of this anomaly," said Mark Carlson, a member of an independent panel that reviewed the issue for the company.