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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.
https://www.accessdata.fda.gov/cdrh_docs/pdf12/K121611.pdf
The TorqVue FX Delivery System contains a flex delivery cable assembly that incorporates a nitinol core wire surrounded by a stainless steel coil capped by a hub and a self-sealing hemostasis valve.
https://manuals.sjm.com/~/media/manuals/product-manual-pdfs/f/c/fcba81dd-ae2f-46fb-9306-40d1418d6240.pdf
The AMPLATZER™ TorqVue™ delivery system is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the …
https://www.dicardiology.com/content/st-jude-medical-recalls-amplatzer-torqvue-fx-delivery-system
February 13, 2013 — 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://medicalmaterials.com/all-products/amplatzer-torqvue-180-delivery-system-6fr-x-60cm/
Over 60,000 unopened and expired medical products from 100+ OEMs available at 50%-90% below MSRP for non-clinical R&D, Research, Bench Testing, Sales and Teaching.
http://professional.sjm.com/~/media/pro/resources/ifu/amplatzer-us/sh-ds/600266-002_TorqVue_Del_Syst_secure_amplatzer_torqvue_45and180_delivery_system_us.ashx
The AMPLATZER TorqVue delivery system is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.
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