Edwards' recall gets FDA's 'deadly' label as problems pile up

Edwards is recalling components of its Embol-X devices.--Courtesy of Edwards

Edwards Lifesciences ($EW) has recalled a fleet of its bypass catheters over deformed tips, and the FDA has assigned its most serious label to the effort, heaping trouble onto what has been a trying few weeks for the California devicemaker.

At issue is Edwards' Embol-X Glide Protection System, an access catheter used to capture blood clots and tissue fragments during bypass surgeries. The devices' cannula tips are deformed, according to the company, upping the chances for separation and embolization during insertion or removal. Edwards is asking its customers to quarantine their Embol-X cannulae and ship them back to the company. The devices' other components are not affected.

The FDA has assigned its Class I tag to the recall, warning that using the device could lead to serious adverse events including death. Edwards said it hasn't heard reports of any related patient injury, and the agency is asking patients and physicians to report any problems through its MedWatch system.

The recalled devices were manufactured at Edwards' Draper, UT, facility, the same one hit with an FDA warning letter this year, but the company said the two issues are unrelated. Edwards has already collected all of the affected products in the field and expects to ship replacements by the end of this week, a spokeswoman said.

Edwards' shares have fallen almost 20% over the past two weeks as investors doubt the company's ability to capitalize on its market leadership in the transcatheter aortic valve world. Quarter after quarter, Edwards has posted slower-than-expected sales growth for its banner Sapien valve, reducing its annual guidance amid mounting shareholder lawsuits. Now, with Medtronic ($MDT) accelerating its U.S. commercialization schedule for the competing CoreValve and Boston Scientific ($BSX) bullying into Europe with Lotus, Edwards' position at the top of TAVI is starting to look vulnerable.

- read the FDA notice
- check out Edwards' letter (PDF)

Editor's note: This story was updated to include comments from Edwards Lifesciences.