The U.S. Food and Drug Administration has slapped a Class I classification on its recall of Edward Lifesciences’ EW Sapien 3 Ultra delivery system as a result of several injuries and at least one report of a death associated with its use. According to a news report, this recall comes a week after the company’s Sapien 3 and Sapien 4 Ultra heart valves’ received approval for use in surgeries with low death risk. The Sapien 3 Ultra delivery system is designed to deliver a transcatheter heart valve to replace a diseased aortic valve without open-heart surgery.
In July 2019, Edwards Lifesciences initiated a Field Corrective Action after receiving reports of 17 injuries and one death from the use of the system. The company issued a safety notice to customers and physicians. It recommended that the balloon in the delivery system be inflated at a slow and consistent pace while deploying the heart valve to avoid rupture. The use of the affected product may cause serious adverse health consequences as well as death. Patients who had the transcatheter aortic valve replacement procedure using the Edwards SAPIEN 3 Ultra Transcatheter Heart System are most susceptible to these risks.
Products Are Still in the Market
The company said it is not removing the delivery system from the market yet and has updated the instruction for use to its customers. However, the FDA is using the term “recall” since the manufacturer, in this case, is undertaking remedial action. The FDA said that the balloons that ruptured during the implantation procedures made it difficult for the recovery of the valve into the catheter and withdrawal of the system from the patient’s body. The FDA also said the recall includes 1,585 heart valve delivery systems.
This is not the first recall for Edwards Lifesciences. In July 2019, the FDA said that three deaths had been linked to one of its recalled heart devices – the IntraClude intra-aortic occlusion device, which has now been characterized as a Class I recall. The FDA has also noted that the recall affects more than 750 devices in the United States. The recall was spurred by the risk of balloon rupture during use of the devices. The company had received as many as 22 complaints related to that device.
Dangerous and Defective Devices
Defective medical devices have the potential to cause catastrophic injuries or even fatalities, as we’ve seen with these heart valve delivery systems. Manufacturers have the responsibility to issue prompt recalls and let doctors and customers know about the potential dangers. If you or a loved one has been injured or if you have lost a loved one as the result of a defective medical device, please contact an experienced product defect lawyer who can help protect your rights and help you hold the negligent manufacturer accountable.