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

Corrected February 13, 2013, at 12:00 p.m. to clarify that the recalled component is part of the Amplatzer Atrial Septal Occluder.

St. Jude Medical logo

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 hole in the heart that, if left unclosed, may allow blood clots to travel from 1 side of the hart to the other and then to the brain, causing a stroke.

"The company has identified that in a small number of cases, the core wire could potentially fracture when exposed to a combination of certain cardiac anatomies and implant practices," St. Jude spokeswoman Amy Jo Meyer told MassDevice.com. "To date, no serious injuries have occurred as a result of this issue and if the device has already been used successfully, there is no cause for concern or additional action."

St. Jude began notifying its customers via an "Urgent Medical Device Recall Notice" sent to customers last month, according to the FDA notice.

"The letter advised customers to stop using the device and remove it from their inventory," the federal watchdog agency noted. "St. Jude Medical plans to have their sales representatives perform site visits to assist with recall activities, including completion of the product reconciliation form and return of any unused product."

"St. Jude Medical is taking a conservative approach in removing all remaining inventory," Meyer told us. "Physicians may continue using the previous, standard version of the TorqVue Delivery System, which does not have the same core wire design."

The FDA gave the recall Class I status, usually reserved for "the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."

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