FDA MedWatch – Optisure Dual Coil Defibrillation Leads by St. Jude Medical: Class I Recall – Damage May Prevent Patient Therapy
On January 26, 2016, the U.S. Food and Drug Administration (FDA) listed a Class I recall of Optisure Dual Coil Defibrillation Leads manufactured and distributed by St. Jude Medical Inc. Class I recalls are the most serious type of recall, issued only when the FDA finds a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled Optisure Dual Coil Defibrillation Leads are implanted wires that connect a defibrillator to a patient’s heart. Defibrillators monitor the patient’s heartbeat and if necessary send an electrical current to jolt the heart back into a normal rhythm. However, due to a manufacturing error affecting the Optisure lead’s insulation, the defibrillator may fail to deliver the needed current.
The recall encompasses a select group of 447 Optisure leads distributed between April 9, 2014 and October 20, 2015, encompassing model numbers: LDA220, LDA220Q, LDA230Q, LDP220Q.
If you or a loved one suffered injuries that you believe were caused by a St. Jude Medical Optisure Dual Coil Defibrillation Leads contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today