July 2, 2014 — St. Jude Medical says it has been notified by the U.S. Food and Drug Administration (FDA) that problems have been addressed at a facility in Sylmar, California, where the Durata and Riata ST Optim leads for implantable defibrillators are made.
In a statement from the CEO of St. Jude, 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 January last year, the facility was cited in a warning letter after inspectors found 11 violations of good manufacturing practices, including quality control and documentation processes.
The Durata and Riata are high voltage implantable cardiac leads that connect an implantable cardioverter defibrillator (ICD) to the heart in order to monitor heart rhythms. The ICD detects life-threatening heart rhythms and can deliver an electrical shock through the lead to the heart.
The problem is that the insulation on the Riata and Durata leads could fail prematurely and expose the electrical conductors inside the wire. The devices were pulled off shelves in 2010 as St. Jude cited issues with “externalized conductors as a result of inside-out abrasion.”
In November 2011, St. Jude issued another warning. One month later, the FDA issued a Class I recall of the devices. The FDA expressed concern that insulation problems could increase the risk of electrical failure. Defective defibrillators could potentially deliver an unnecessary electrical shock or fail to deliver a shock in an emergency.