FDAFDA · Alimentos y medicamentos·N.º oficial Z-1041-2024
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded. There are a total of 208 Optima Coil models. Optima Coil Model Numbers and Product description: OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Opti
Publicado el 14 de febrero de 2024 · Inicio del retiro: 3 de enero de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- BALT USA, LLC
- Distribuidor
- U.S.: AZ, CA, CO, FL, GA, HI, IL, KS, MA, ME, MO, MS, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, VT, WI and Puerto Rico O.U.S.: Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominican Republic, Ecuador, France, Indonesia, India, Japan, Korea, Malaysia, Mexico, Panama, Paraguay, Peru, Russia, Uruguay, and Vietnam.
- Lote
- Refer to Attachment 1 for list of affected products including the products' Lot Number, Product model number, UDI and expiration date. Optima Coils ( Lot Number/Model Number/Product Description/UDI-DI Code: F201000528 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F201200957 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210100206 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210200292 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210200541 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210300015 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210301053 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053022128 F201000069 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201000337 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201000484 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201000927 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201001145 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100048 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F201100121 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100149 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100164 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100280 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100302 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100344 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100418 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100469 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F201100501 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F201100613 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201200023 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201200033 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F201200162 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201200176 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F201200687 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201200748 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201201117 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100085 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100237 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100246 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100285 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100453 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100913 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100922 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100973 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F210200003 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210200071 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053021411 F210200099 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F210200105 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053022135 F210200109 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F210200176 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F2102001
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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