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Recall Observatory FDA recall evidence

Device product

Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.

Z-1271-2016

February 09, 2016

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 73426
Status
Terminated
Classification
Class II
Quantity
9 (1 still unused)
Official record key
device-enforcement:Z-1271-2016

Official wording

Reason: 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.

Code information: N558983006

Distribution pattern: Internationally to Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.