U.S. Markets open in 8 hrs 58 mins

Edwards Lifesciences Sapien 3 System Recall Classified Class I

Zacks Equity Research

FDA has classified its recent recall of Edwards Lifesciences’ EW Sapien 3 Ultra delivery system as Class I due to health risks associated with its use. However, the products will remain in the market as of now.

The recall comes a week after the company's Sapien 3 and Sapien 3 Ultra heart valves’ receipt of FDA approval for use in surgeries at low death risk. Following the news of this major setback, shares of Edwards Lifesciences have dropped 2.6% to close at $216.67 yesterday.

More About The Product Recall

The Sapien 3 Ultra delivery system has been designed to deliver and deploy a transcatheter heart valve to replace a diseased aortic valve without open-heart surgery.

In July 2019, Edwards Lifesciences initiated the Field Corrective Action after receiving reports of 17 injuries and a 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 affected product may cause serious adverse health consequences as well as death. Patients who had a transcatheter aortic valve replacement procedure using the Edwards SAPIEN 3 Ultra Transcatheter Heart System are most susceptible to these risks.

As per a Reuters article, the company stated it is not removing the delivery system from the market and has updated the instructions for use to its customers. However, the FDA has used the term "recall" since it is a case of a manufacturer undertaking a remedial action. The regulatory body stated that the balloons that ruptured during implantation procedures made it difficult for the recovery of the valve into the catheter and withdrawal of the the system from a patient's body. The FDA also stated that the recall includes 1,585 heart valve delivery systems.

According to the company, the FDA's decision to categorize the issue as a Class I recall should be acknowledged of its seriousness.

However, Edwards Lifesciences has added that the recall is not likely to affect the company's revenue projection.

Recent Product Recalls

In July 2019, FDA stated that three deaths had been reported thanks to Edwards Lifesciences’ recall of one of its heart devices. The regulatory body stated the company’s voluntary recall of its IntraClude intra-aortic occlusion device in May has now been categorized as Class I.FDA also noted that the recall affects more than 750 devices in the United States. The recall was made on account of risk of balloon rupture during use of the devices. The company had received as many as 22 complaints related to the device.

Price Performance

In the past year, the company’s shares have outperformed the industry. The stock has gained 52.9% compared with the industry’s 4.6% fall.

Zacks Rank and Key Picks

Edwards Lifesciences currently carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the broader medical space are Medtronic MDT, Baxter BAX and Amedisys AMED, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Medtronic’s long-term earnings growth rate is expected at 7.13%.

Baxter’s long-term earnings growth rate is projected at 12.8%.

Amedisys’ long-term earnings growth rate is expected to be 16.3%.

Wall Street’s Next Amazon

 Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.

Click for details >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Baxter International Inc. (BAX) : Free Stock Analysis Report
Medtronic PLC (MDT) : Free Stock Analysis Report
Edwards Lifesciences Corporation (EW) : Free Stock Analysis Report
Amedisys, Inc. (AMED) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research