FDA-Device2016-04-06Class II
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Medtronic Neuromodulation
Hazard
Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intrathecal Catheter kit. We have identified that this kit may have been produced with incorrect outer package labels. As a result, it may not contain all components necessary to complete the implant procedure.
Sold states
Internationally to Japan.
Affected count
9 (1 still unused)
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1271-2016Don't want to check this manually?
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