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FDA Recalls St. Jude’s Riata Lead Based on Risk of Death

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St. Jude Medical Inc.’s Riata defibrillator leads, which the company stopped selling last year, were recalled by the U.S. Food and Drug Administration because of their potential to injure or kill patients.

The devices remain implanted in an estimated 79,000 U.S. patients. The company voluntarily sent a letter to doctors on November 28 informing them that the wires used to connect the devices to the heart have a higher failure rate than was previously known.

According to the company, the FDA issued the Class 1 recall, its most serious designation, because of its potential risk of serious injury or patient death.

The company acknowledged that the wires inside some leads can penetrate the insulation, compromising the device’s integrity. The devices may inappropriately shock some patients and fail to deliver necessary therapy to others.

This potential for device failure, particular for defibrillators or for folks dependant on pacemakers, is worrisome.

Patients who need frequent shocks from their defibrillator to restore a normal heart rhythm and those who are dependant on pacemakers may be at greater risk, the company said. Doctors may design individual treatment plans for those with the damaged wires based on their risk level and options should be discussed with patients, the company said.

FDA notified healthcare professionals of a Class I Recall of the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads. The silicone insulation covering these defibrillation leads is at risk of premature abrasion. When abrasion occurs, the conductors inside the leads can come out (externalized) of the insulation. Leads with externalized conductors may develop electrical dysfunction and not work as intended. In the event the device does not work as intended, should a life-threatening heart rhythm occur, pacing or defibrillation therapy may not be delivered as intended. This may result in serious adverse events, including death.

The recall includes the following model numbers:

Riata (8F) Silicone Endocardial Defibrillation Leads
Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
Riata ST (7Fr) Silicone Endocardial Defibrillation Leads
Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042

BACKGROUND: The leads connect an implantable cardioverter defibrillator (lCD) or cardiac resynchronization therapy defibrillator (CRT-D) to cardiac tissue in order to monitor and regulate a patient’s heart rate by providing pacing and delivery of high voltage therapy for ventricular arrhythmias.

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  1. joyce banovz says:
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    My husband has the 1580 and he is 100% dependant on the pacemaker, and does have heart failure. We just recieved the letter notifing us of this recall. I called his doctor’s office and they said to just continue to be home monitered and also they check it at the office. He said they would know there was aproblem before he would. Somehow this just doesn’t make any sence. Now one of the problems he has is infection concerns as the 1st ICD became infected. So, there are a lot of concerns here. Why don’t they do more studies on these prior to placing them in humans bodies?

  2. Maria says:
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    My husband had this lead wire placed in 2010. As I write this, he is recovering from having new wires and unit placed due to having been shocked 6 times, that were unsuccessful, and no evidence why he was shocked. We were not infomed rhere was a recall until I spoke with his doctor after the procedure! Believe me, I will be checking into this. Being an RN myself, this is very upsetting along with having him shocked for no reason.