In short
We’ve written only this week about the Amplatzer™ PFO Occluder and St.Jude’s efforts to find clinical evidence supporting its use. Probably the last thing the company wants is a product related FDA recall on its hands, but that’s what it now has. The FDA has followed St.Jude’s January recall of the delivery system designed to insert the Amplatzer occluder, by now issuing its own Class I recall notice. This level of recall implies that the failure could result in adverse health consequences or death.
Background
The Amplatzer TorqVue FX Delivery System is used to assist the attachment, loading, delivery, and deployment of Amplatzer Occluder devices. Amplatzer Occluder devices are used to close openings between the two upper chambers of the heart, the so-called patent foramen ovale, or PFO.
The reason for the recall is that it seems the distal end of the core wire of the delivery system could potentially fracture in a small number of cases.
According to the FDA recall notice, on January 17, 2013, St. Jude Medical sent an “Urgent Medical Device Recall Notice” to its customers. The letter advised customers to stop using the device and remove it from their inventory.
The following part and lot numbers are involved. These were all manufactured between August 24, 2012 and September 24, 2012 and distributed October 1, 2012 – January 9, 2013.
9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80,
9-ITVFX09F45/80, 9-ITVFX10F45/80, 9-ITVFX12F45/80, 9-ITVFX13F45/80
St. Jude Medical says it plans to have its sales representatives perform site visits to assist with recall activities, including completion of the product reconciliation form and return of any unused product.
Source: FDA