St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication - Premature Insulation Failure
MedSun: Newsletter #76, September 2012

FDA Medical Device Safety

Physicians should continue to closely monitor patients who have a Riata or Riata ST lead and notify patients if they have a recalled lead. Patients who have not had a recent evaluation and device interrogation should undergo those exams to assess for any electrical abnormalities. Physicians should consider remote monitoring for patients with a recalled lead to better detect electrical abnormalities.

Additional Information:

FDA Medical Device Safety. St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication - Premature Insulation Failure. August 16, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm315718.htm


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