August 17, 2012 — Minnesota-based medical device company St. Jude Medical has voluntarily recalled the QuickFlex and QuickSite defibrillator leads on April 3, 2012, in a Class II recall.
The company has stopped selling and marketing the products, but thousands of people may be implanted with these devices. QuickFlex and QuickSite defibrillator leads have been sold in the U.S., and more than 100,000 were sold worldwide. Recently, the FDA required a three-year safety study of the devices.
St. Jude said that the recall was prompted by “Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads.” Some wires that are externalized may have no electrical or performance problems, and St. Jude did not recommend surgery to remove the QuickSite and QuickFlex leads.
Both the QuickSite and QuickFlex are CRT devices. These devices are small, battery-powered defibrillator units. They are implanted in the chest of a person who is at risk of heart failure due to severe cardiac arrhythmia.
The defibrillator leads are the wires that connect the voltage-providing defibrillator to tissue in the heart. Unfortunately, the problem with these devices is that, in some cases, the electrical wire may wear through its insulation. If the wire is externalized, there is a risk that it could deliver an unnecessary shock or fail to deliver a shock. Both of these situations are life-threatening.
Further complicating matters, not all externalized wires are defective, and it can be difficult or impossible to determine whether an externalized defibrillator lead is at risk of malfunctioning until an adverse event occurs.
The QuickFlex and the QuickSite are not the only St. Jude defibrillator leads that have been recalled. In November 2011, the company recalled the Riata and Riata ST defibrillator leads. The FDA has recently recommended that people with the Riata leads should have routine chest X-rays to check for externalized cables.
Although the FDA did not recommend chest X-rays for people with the QuickFlex and QuickSite, St. Jude recommended in the recall that physicians continue to monitor their patient’s implanted systems at regular intervals.
The FDA has also asked St. Jude to conduct a three-year post-marketing surveillance study of the QuickFlex and QuickSite. This study will help the FDA better understand how many people have problems with the leads, how often serious injuries occur, how often injuries occur when the devices are removed, and more.