Medical devices major
St. Jude Medical Inc.
) is voluntarily recalling its Amplatzer TorqVue FX Delivery
System because the product could cause fatal injuries to
patients. The Food and Drug Administration (FDA) issued a Class I
recall of the product, which is considered to be the most serious
type of recall.
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The device from the company's Cardiovascular and Ablation
Technologies Division was used to precisely implant the Amplatzer
occluders to close or seal holes in patient's hearts. The company
had started manufacturing and distributing the delivery system in
2012 but stopped selling it from Jan 2013, when it was found that
the core wire could fracture leading to severe consequences. The
company also notified its customers to stop using the product
St. Jude is also trying to solve a manufacturing and quality
systems-related problems at its Sylmar facility, which
manufactures the highly controversial Riata ST Optim and Durata
leads. The company received a warning letter from the FDA in Jan
2013 regarding the problems. The FDA is concerned that the newer
generation Durata leads might face the same problem as the Riata
leads, which had been recalled by the company in 2011.
The recall of the delivery system further increases concerns
regarding the company's product offerings. St. Jude's shares
dropped by 0.77% to close at $42.60 on Feb 12.
St. Jude's peer,
) is also facing problems with the recall of its Neptune waste
management system, which is likely to dampen sales in its
instruments business in 2013. Health care products major,
) has been hit by a number of product recalls as well, the most
significant being the voluntary recall of the Duet offering.
St. Jude has a Zacks Rank #3 (Hold). While we remain on the
sidelines regarding St. Jude, medical products companies such as
), which carries a Zacks Rank #1 (Strong Buy), appear