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https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=115439
The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions. FDA Determined Cause 2: Device Design: Action: St. Jude Medical sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated January 18, 2013 to all affected customers.
https://www.dicardiology.com/content/st-jude-medical-recalls-amplatzer-torqvue-fx-delivery-system
St. Jude Medical has issued a Class I recall for its Amplatzer TorqVue FX Delivery System used in transcatheter closure of atrial septal defects (ASDs). The company said in a small number of cases, the distal end of the core wire of the TorqVue FX system can fracture, which has the potential to cause serious adverse health consequences, including death.
https://www.accessdata.fda.gov/cdrh_docs/pdf12/K121611.pdf
AMPLATZER TorqVue Delivery System (JTV) and AMPLATZER TorqVue 450x45' Delivery Sheath (TV 450x450), respectively. With the exception of the delivery cable, extension wire, and hemostasis valves, the components used in the ITV FX are identical to those used in ITV and/or TV 450x45'. A high-level comparison of TorqVue EX Delivery System
https://www.medlatest.com/companies/st-jude/fda-class-recall-st-judes-amplatzer-torqvue-fx-delivery/
FDA Class I Recall For St. Jude’s Amplatzer™ TorqVue FX Delivery System. 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 …
https://professional.sjm.com/~/media/pro/resources/ifu/amplatzer-us/sh-asd/600208-011_ASD_eIFU_Secure_amplatzer_septal_occluder_us.ashx
Figure 2. AMPLATZER Delivery System. A. Loader – used to introduce the AMPLATZER Septal Occluder into the delivery sheath B. Hemostasis valve with extension tube and stopcock – allows flushing of the delivery system and controls back-bleeding C. Delivery sheath – provides a pathway through which a device is delivered
https://professional.sjm.com/~/media/pro/resources/ifu/amplatzer-us/sh-ds/600274-002_TorqVue_45_x_45_eIFU_amplatzer_torqvue_45x45_us.ashx
The AMPLATZER TorqVue 45° x 45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart. Contraindications None known. Warnings • Do not use this device if the sterile package is open or damaged.
https://www.nasdaq.com/articles/st-jude-recalls-amplatzer-device-analyst-blog-2013-02-13
Feb 13, 2013 · M edical devices major St. Jude Medical Inc. ( STJ) is voluntarily recalling its Amplatzer TorqVue FX Delivery System because the product could cause fatal injuries to …
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