A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication – Premature Insulation Failure. According to the Food & Drug Administration FDA’s MedWatch:
ICD lead malfunction may cause abnormal sensing or pacing, or delivery of inappropriate or no shock therapy, which could result in serious adverse events, including death.
For more information on the drug or medical device recall or safety alert, read the Food & Drug Administration’s FDA’s drug or medical device recall or safety alert: St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication – Premature Insulation Failure.
To report an adverse reaction, problem or other issue with a drug or medical device, submit a drug or medical device complaint to the government at fda.gov or MedWatch.
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