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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2352-2024

Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)

Publicado el 24 de julio de 2024 · Inicio del retiro: 10 de mayo 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

Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Medtronic Neuromodulation
Distribuidor
Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Argentina, Aruba, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Cyprus, Czech Rep, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Guadeloupe, Germany, Greece, Hong Kong, Hungary, Indonesia, Italy, Iran, Islamic Republic, Iraq, Ireland, Jordan, Kazakhstan, Korean Republic of, Kuwait, Latvia, Lebanon, Lithuania, Libya, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherland, New Zealand, Norway, Oman, Panama, Pakistan, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirate, and United Kingdom.
Lote
a) 8780: 1) UDI/DI 00643169202122, Lot/Serial Numbers: N690838001, N690838004, N690838005, N690839001, N690839002, N690839003, N690839004, N690839005, N690839006, N690840001, N690840002, N690840003, N690840004, N690840005, N690840006, N690841001, N690841004, N690841005, N690842001, N690842003, N690842004, N690842005, N690843001, N690843003, N690843004, N690843005, N690915002, N690915003, N690915005, N690916001, N690916002, N690916003, N690916005, N690916006, N690917002, N690917003, N690918001, N690918002, N690918003, N690918004, N690918005, N690918006, N690919001, N690919002, N690919003, N690919005, N690919006, N690920001, N690920004, N690920005, N691336003, N691336004, N691336005, N691338001, N691338003, N691338004, N691338005, N691338006, N691456001, N691456002, N691456005, N691461001, N691461002, N691461004, N691461006, N691464002, N691464003, N691464006, N691468001, N691468002, N691468003, N691468005, N691468006, N691479002, N691479003, N691479004, N691479006, N691482001, N691482002, N691482003, N691482004, N691482005, N691506002, N691506003, N691506004, N691508003, N691508004, N691517001, N691517002, N691517004, N691517005, N691522001, N691522002, N691522003, N691522004, N691522005, N691522006, N691524001, N691524002, N691524003, N691524004, N691524005, N691524006, N691527002, N691527003, N691527004, N691527005, N691527006, N691528001, N691528003, N691528004, N691528005, N691528006, N691529002, N691529003, N691529005, N691540001, N691540003, N691540005, N691540006, N692151001, N692151002, N692151003, N692151005, N692155002, N692155003, N692155004, N692156001, N692156002, N692156003, N692156004, N692156005, N692173002, N692173003, N692173004, N692173006, N692174001, N692174002, N692174003, N692174004, N692174005, N692174006, N692175001, N692175002, N692175003, N692175004, N692175005, N692175006, N692176001, N692176002, N692176003, N692176004, N692176005, N692178001, N692178002, N692178004, N692178005, N692179001, N692179002, N692179003, N692179005, N692180002, N692180003, N692180004, N692180005, N692180006, N692186001, N692186002, N692186003, N692186004, N692186005, N692186006, N692205001, N692205002, N692205004, N692205005, N692205006, N692207001, N692207002, N692207003, N692207004, N692207005, N692207006, N692209001, N692209003, N692209004, N692209005, N692367001, N692367002, N692367003, N692367004, N692367005, N692367006, N692993001, N692993002, N692993004, N692993005, N692999001, N692999005, N693001001, N693001002, N693001003, N693001004, N693001005, N693001006, N693003001, N693003002, N693003003, N693003004, N693003005, N693005002, N693005004, N693005005, N693007004, N693007005, N693007006, N693220001, N693220002, N693220003, N693220004, N693220006, N693221001, N693221002, N693221003, N693221004, N693221006, N693233002, N693233003, N693233004, N693233005, N693233006, N693239002, N693239003, N693239004, N693251001, N693251002, N693251003, N693251004, N693251005, N693390001, N693390003, N693390005, N693396001, N693396002, N693396003, N693396004, N693396005, N693401001, N693401003, N693401004, N693401005, N693407001, N693407002, N693407003, N693407004, N693407005, N693407006, N693410001, N693410002, N693410003, N693410004, N693410006, N693413001, N693413002, N693413003, N693413006, N693425001, N693425002, N693425003, N693425004, N693425005, N693425006, N693457004, N693457005, N693457006, N693458001, N693458002, N693458003, N693458004, N693458005, N693458006, N693478001, N693478002, N693478003, N693478004, N693478005, N693480001, N693480004, N693480005, N693480006, N693485001, N693485002, N693485003, N693485005, N693485006, N693498002, N693498004, N693498005, N693498006, N693499001, N693499002, N693499004, N693499005, N693499006, N693502001, N693502002, N693502003, N693502005, N693502006, N693852001, N693852003, N693852004, N693852005, N693855001, N693855002, N693855003, N693855004, N693857001, N693857002, N693857004, N693857005, N693857006, N693858001, N693858002, N693858003, N693858004, N693858005, N693860003, N6938
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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