A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall – Failures with Lead Insulation. According to the Food & Drug Administration FDA’s MedWatch:
Premature insulation abrasion may cause the conductors to become externalized, which can cause serious adverse health consequences, 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 and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall – Failures with Lead Insulation.
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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