Recall archive / FDA device enforcement

Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit) — FDA record Z-2352-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 10, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Reason: 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.
Classification: Class II
Recalling firm: Medtronic Neuromodulation
Quantity: 111762 units
Agency-reported status: Ongoing
Source record identifier: Z-2352-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, 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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, 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N696782005, N696782006, N697171001, N697171002, N697171003, N697171004, N697177001, N697177002, N697177003, N697177004, N697179001, N697179002, N697179003, N697179004, N697179005, N697189002, N697189003, N697189004, N697189005, N697209001, N697209003, N697209004, N697209005, N697209006, N697216001, N697216002, N697216003, N697216005, N697216006, N697237001, N697237002, N697237003, N697237004, N697237005, N697237006, N697241001, N697241003, N697241004, N697241005, N697241006, N698587002, N698587004, N698587005, N698590001, N698590002, N698590003, N698590005, N698591001, N698591002, N698591003, N698714002, N698714003, N698714004, N698717001, N698717002, N698717004, N698719002, N698719003, N698719004, N698719005, N698721003, N698721005, N698721006, N698723002, N698723003, N698723004, N698723005, N698723006, N698731001, N698731002, N698731003, N698731004, N698731005, N698732002, N698732003, N698732004, N698732006, N698733002, N698733004, N698733005, N698733006, N698900001, N698900002, 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N701932005, N701932006, N701935001, N701935002, N701935004, N701935005, N7...

Label field

Details supplied by the agency

Lot, code or applicability

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, 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N701935001, N701935002, N701935004, N701935005, N7...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jul 24, 2024
Recall initiation date: May 10, 2024
Center classification date: Jul 12, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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