July 2, 2014 — The U.S. Food and Drug Administration (FDA) says St. Jude Medical has addressed quality control issues at a facility that manufactured defibrillator leads that were recalled in 2011.
The facility in Sylmar, California, manufactured the Durata and Riata ST Optim leads for implantable cardioverter defibrillators (ICD). The leads connect the defibrillator to the heart, monitor heart rhythm, and deliver a high-voltage electrical shock if necessary.
At least 11 violations of good manufacturing practices were cited in a warning letter issued in January 2013, including issues with quality control and documentation processes.
According to a statement from St. Jude CEO Dan Starks:
“We take our responsibility as a medical device manufacturer very seriously. We are encouraged by the resolution of the FDA’s warning letter and will continue to work to ensure the highest standards are met across our manufacturing facilities.”
In 2010, St. Jude stopped selling the leads after finding issues with “externalized conductors as a result of inside-out abrasion,” but did not issue a recall until 2011. The FDA expressed concern that electrical failure could occur when the insulation detached.
Insulation defects could potentially cause the defibrillator to deliver an unnecessary shock, or fail to deliver a shock in an emergency. Unfortunately for patients who were already implanted with the device, it was difficult for doctors to determine whether the lead was at risk of failure.
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The Schmidt Firm, PLLC is currently accepting St. Jude Riata and Durata induced injury cases in all 50 states. If you or somebody you know has been injured by a defective defibrillator lead, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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