Patent foramen ovale (PFO) is a birth defect that occurs when then a hole between the right and left atria fails to close after birth.  It is can be caused by maternal use of SSRI drugs during pregnancy.  Anyone unlucky enough to have been born with PFO may now have just been dealt another blow:


The FDA issued the highest-risk label on St. Jude Medical’s (NYSE:STJ) recall of its Amplatzer TorqVue FX delivery system.


St. Jude recalled a component of its Amplatzer Occluder over concerns that part of the delivery system may fracture, potentially causing adverse consequences or even death, according to the FDA report.

The Amplatzer device was designed to treat a condition called patent foramen ovale, in which a naturally occurring hole in the heart fails to close after birth, potentially allowing blood clots to travel from 1 side of the hart to the other and then to the brain, causing a stroke.


Source: FDA slaps highest risk label on St. Jude Medical’s Amplatzer TorqVue FX recall | MassDevice


The recalled devices were those made from August 24th of 2012 through September 24th of 2012.  They were distributed from October 1st of 2012 through January 9th of 2012.  The recall was initiated on January 18th, but it took a little time to make its way to the FDA website.  Here is the FDA on the recall. 


I’m not sure how widely used the product was.  On the one hand, as many as 1 in 4 people may have a PFO.  (Many people never even know they have it.)  But on the other hand, this product was only manufactured for a month.  There can’t be ten million of them in the marketplace.  Time will tell if there will be any Amplatzer TorqVue lawsuits or other legal issues to blog about here.