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

Recall details

Manufacturer

Medtronic Neuromodulation

Distributor

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.

Lot

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

Risk classification

Class II

Area (FDA)

device

Country

United States