If you or a loved one has a St. Jude Medical defibrillator and Durata leads, please contact us today for a free legal consultation. Time is limited.
In 2011, the FDA recalled the St. Jude Medical, Inc. ICD lead wires called Riata. Shortly after the Riata was pulled off the market, St. Jude Medical put out another product called the Durata.
St. Jude Durata Model Numbers are as follows: 7120, 7121, 7122, 7170, 7171 – there are size variations which will follow the model numbers (i.e. 7170Q/65)
The claim by St. Jude was the Durata model leads would not have the same problems as the Riata and that the insulation would prevent the leads from failing.
Two authoritative reports have been released, identifying failures in the Durata leads. You can read both reports via this link:
Essentially, what the studies have shown is that the Durata ICD leads are the same product as the Riata in that they fail in the same way. The design is essentially the same and the modifications made to the insulation of the Durata did not prevent the erosion of the outer coating.
During an FDA inspection, the following warning letter was sent to St. Jude Medical: