Medtronic Neuromodulation recalls Synchromed II programmable pump, Model numbers 8637-20 and 8637-40

Recall date

October 11, 2019

Source

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

Recall number

Z-0508-2020

FDA classification

Class I

Brand / firm

Medtronic Neuromodulation

Sold / distributed

US and Canada, Asia -Pacific (APAC), China, Europe, Middle East and Africa (EMAE), Latin America (LATAM)

Why it was recalled

There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Synchromed II programmable pump, Model numbers 8637-20 and 8637-40