August 17, 2012 — St. Jude Medical voluntarily recalled the QuickSite and QuickFlex defibrillator leads on April 3, 2012. Although St. Jude has stopped marketing and selling the defibrillator leads, they are still implanted in thousands of people — approximately 60,000 QuickSite and QuickFlex defibrillator leads were sold in the United States. Although St. Jude does not recommend surgery to remove the recalled defibrillator leads, they are recommending they physicians continue to monitor patients on a regular schedule. The FDA has recently required St. Jude to conduct additional safety studies of the QuickFlex and QuickSite.
The QuickFlex and QuickSite are CRT devices. They are small, battery-powered units that are implanted in the chest of patients who have heart failure and need a defibrillator to deliver an electrical shock in the event of a life-threatening irregular heart rhythm.
According to St. Jude, they initiated the recall due to: “Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads.” However, they caution that physicians may observe externalized wires without finding electrical or performance abnormalities.
The defibrillator lead is the wire that connects the defibrillator to the heart tissue. The problem with several St. Jude leads is that the insulation around the electrical wire can erode, allowing the wire to externalize outside the insulation. In some cases, the wire may malfunction, and either deliver an unnecessary shock or fail to deliver a shock during an emergency.
The FDA has recently required St. Jude to conduct a three-year post-marketing surveillance study of the the risks associated with the QuickFlex and QuickSite. The studies will help the FDA better understand how many people suffer problems with the devices, when these problems occur, how often serious injuries occur during surgical removal of the devices, and more.
In some cases, the FDA is recommending chest X-rays to check for externalized leads. They are not recommending that patients have the leads removed, because this surgery is very dangerous, except in cases where the leads are externalized and a voltage test is abnormal.
The recall of the QuickFlex and QuickSite follows the November 2011 recall of the St. Jude Riata and Riata ST defibrillator leads. The FDA is recommending that people with those defibrillator leads should undergo routine chest X-rays to check for externalized wires. In the recall for the QuickFlex and QuickSite, St. Jude recommended that physicians continue to monitor their patients are regular intervals.