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

Recall date

February 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1271-2016

FDA classification

Class II

Brand / firm

Medtronic Neuromodulation

Sold / distributed

Internationally to Japan.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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