St. Jude Recall – Defibrillator
St. Jude Recall
Notice regarding the St. Jude Recall. If you have one of these devices or know of anyone with one of these defective devices, please give our office a call immediately for a Free Consultation.
To date, of the 398,740 affected devices sold worldwide, 841 were returned for analysis due to premature battery depletion caused by lithium clusters.
- 2 deaths (1 in the U.S.), have been associated with devices that could not provide needed shock therapy due to premature battery depletion.
- 10 patients (9 in the U.S.), have reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion.
- 37 patients (30 in the U.S.), have reported dizziness from devices that could not provide needed pacing therapy due to premature battery depletion.
This is not the first St. Jude recall.
St. Jude Medical Recalls Optisure Dual Coil Defibrillation Leads Due to Damage that May Prevent Patient Therapy
Optisure Dual Coil Defibrillation Leads
Product code information
Model numbers: LDA220, LDA220Q, LDA230Q, LDP220Q
Manufacturing dates: March 12, 2014 to March 22, 2015
Distribution dates: April 9, 2014 to October 20, 2015
Devices recalled in the U.S.: 281 units
Device Use
The Optisure Dual Coil Defibrillation Leads are implanted wires that connect a defibrillator to a patient’s heart. The defibrillator system senses the patient’s heart rhythm and delivers electrical pulses or shocks when it detects a faster than normal heart rate (tachycardia) or completely disorganized electrical activity (fibrillation).
Reason for Recall
St. Jude is recalling the Optisure leads due to a manufacturing error that may have caused damage to the insulation layer of one of the shock coils. Depending on device programming and the depth of the cut, this could result in the inability of the defibrillator to deliver electrical therapy to the patient.
The use of affected products may cause serious adverse health consequences, including patient injury or death.
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If you or someone you know has been the victim of an injury due to this device, you need knowledgeable and experienced attorneys on your side. Eddy DeLuca Gravina & Townsend have successfully represented thousands of accident victims to get them the money they deserve as a result of products liability, accidents or the negligence of others.
To reach us immediately dial (412) 281-5336 or email stownsend@pghlaw.com