FDA Gives St. Jude Recall Class I Status

A St. Jude Medical recall of its Optisure defibrillator leads received Class 1 status from the FDA.

Qmed Staff

FDA announced on Friday that it has given Class I-status to a recall of St. Jude Medical Optisure dual coil defibrillation leads, which are used in defibrillators.

278 of the devices had been distributed in the United States.

The recall was announced owing to the discovery of faulty parts in the device.

The manufacturer had issued a note to physicians recommending that they monitor patients implanted with the 447 Optisure leads that were distributed internationally.

St. Jude reports that it has not received any adverse event reports related to the devices.

It notes that the problem could have been caused by the method used to remove excess adhesive from the shock coil component of the leads, which could have then inadvertently damaged the leads'insulation. The problem could possibly stop the leads from delivering adequate current, making them potentially ineffective at treating patients in the midst of a cardiac arrest. 

Still, the company notes that the possibility of such high voltage short resulting from insulation damage is very low; it estimates the probability to be 0.32%. 

The company has a history with lead problems. Last year, FDA released a safety communication document related to its Riata implantable cardioverter-defibrillator, which had also been recalled. Several lawsuits had also been filed related to the Riata leads.