Medical devices major St. Jude Medical Inc. (STJ) 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.
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 immediately.
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, Stryker Corp. (SYK) 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, Covidien plc (COV) 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 Nuvasive Inc. (NUVA), which carries a Zacks Rank #1 (Strong Buy), appear impressive.
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