Medtronic Neuromodulation recalls SynchroMed II implantable drug infusion pump, Model 8637-40,

Recall date

February 9, 2017

Source

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

Recall number

Z-1694-2017

FDA classification

Class II

Brand / firm

Medtronic Neuromodulation

Sold / distributed

IL

Why it was recalled

Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating the pump; however the pump was providing therapy.

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

What was recalled

SynchroMed II implantable drug infusion pump, Model 8637-40,