A letter recently sent by St. Jude Medical (NYSE:STJ) to customers regarding a problem with some of the device maker’s defibrillator leads has been classified as a Class I recall — for the most dangerous or defective products — by the U.S. Food and Drug Administration.
Although the medical device maker stopped selling the Riata line of leads last year, they were recalled because of the discovery that they had more potential than previously thought to hurt or kill patients. The wires used to connect the defibrillators to the heart may shock patients at inappropriate times or fail to deliver necessary therapy to others, according to St. Jude.
An advisory letter was sent to doctors on Nov. 28 along with recommended instructions for patient monitoring.
The leads remain implanted in 79,000 patients, St. Jude said.
Shares of St. Jude Medical have been in a decline since May, but sunk to a 52-week low on Thursday and fell another 2 percent to $32.93 on Friday. Just two weeks ago, St. Jude shares were trading above $38 after a boost from the approval of the anticipated Unify Quadra cardiac resynchronization therapy defibrillator.
A sluggish heart-rhythm sector has taken a toll on St. Jude; the company’s cardiac rhythm management devices, including defibrillators, provided 56 percent of its total revenue in 2010.
By Deanna Pogorelc MedCity News
Deanna Pogorelc is a Cleveland-based reporter who writes obsessively about life science startups across the country, looking to technology transfer offices, startup incubators and investment funds to see what’s next in healthcare. She has a bachelor’s degree in journalism from Ball State University and previously covered business and education for a northeast Indiana newspaper.More posts by Author
- Get Livefyre
- FAQ
