The FDA has notified healthcare professionals of a Class I recall of St. Jude Medical’s Amplatzer TorqVue FX delivery system because, in a small number of cases, the distal end of the core wire potentially could fracture when exposed to a combination of certain cardiac anatomies and usage conditions.
This recall is for all batches and model numbers of the Amplatzer TorqVue FX. The affected product was manufactured Aug. 24, 2012, to Sept. 24, 2012, and distributed from Oct. 1, 2012, to Jan. 9, 2013.
The Amplatzer TorqVue FX 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.
On Jan. 17, St. Jude 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. St. Jude plans to have sales representatives perform site visits to assist with recall activities, including completion of the product reconciliation form and return of any unused product.
Class I recalls are 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.