Dive Brief:

• Edwards Lifesciences' U.S. recall of 1,585 Sapien 3 Ultra delivery systems received FDA's Class I label Thursday, reserved for device issues that may cause serious injuries or death. The delivery systems are used to deploy certain Edwards transcatheter heart valves.
• The company issued an urgent field safety notice July 9 to inform doctors of cases of burst balloons resulting in difficulty retrieving the valve into the catheter and withdrawing the system, which Edwards said has the potential to cause vascular injury or bleeding to a patient, or require surgical intervention.
• Edwards is aware of one death and 17 injuries linked to the issue, as of the time of the July field corrective action. The 1,585 affected devices were manufactured between Jan. 23, 2018, and July 16, 2019, and have been distributed since Jan. 3.

Dive Insight:

Edwards' stock was down more than 2% at market close Thursday following FDA's notice, in a year when the company's shares have risen more than 40%.

The spotlighted safety concerns come a week after U.S. regulators approved Edwards' Sapien 3 transcatheter aortic valve replacement (TAVR) systems for use in patients with low risk for major complications or death from surgical aortic valve replacement, the once-standard procedure for patients with severe, symptomatic aortic valve stenosis. Edwards first gained FDA approval for the Sapien 3 Ultra system last December in patients with intermediate risk or higher.

Edwards initiated the recall on July 8, according to the FDA. The company is not collecting back any of the affected products.

The agency reiterated that Edwards said in the original urgent field safety notice it would add a warning to the Sapien 3 Ultra instructions for use describing that failure to use "slow, controlled inflation and prescribed nominal inflation volumes may result in balloon rupture, difficulty retrieving the delivery system, and may require subsequent conversion to surgical intervention."

The company advised physicians to inflate the balloon slowly and continuously during deployment, and to hold for three seconds at full inflation. It also offered recommendations on steps to take in the event of a suspected balloon burst.

Jefferies analyst Raj Denhoy downplayed the likely financial impact of the event, saying FDA is simply acknowledging company actions already underway.

"Problems with the Sapien 3 Ultra delivery system are not new news and the FDA's decision to classify them as a Class I recall is more about flagging the issue rather than truly recalling the device," Denhoy wrote in a note to investors Thursday. "[Edwards] is redesigning the Ultra delivery system, with an updated version out soon. The issue is immaterial to revenue."

Analysts at Stifel seemed to agree.

"Unsurprisingly, this typical administrative regulatory process took a bit longer than the initial safety bulletin," the analysts wrote in a note to investors Thursday, adding that on Edwards' second quarter earnings call, the company "indicated Ultra is expected to account for the majority of EW EU valve sales by year-end, suggesting that supply would not be an issue."

This story has been updated with additional analyst commentary and a more current look at stock price.