FDA-Device2019-12-11Class I
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Medtronic Neuromodulation
Hazard
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.
Sold states
US and Canada, Asia -Pacific (APAC), China, Europe, Middle East and Africa (EMAE), Latin America (LATAM)
Affected count
10820 units
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0508-2020Don't want to check this manually?
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