FDAFebruary 9, 2016device
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
medtronic neuromodulationmedtronic
Recall history
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