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Medtronic Neuromodulation recalls Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Recalled December 11, 2019 · FDA recall Z-0508-2020 · 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. · FDA Class I
Units
10820 units
Sold at
US and Canada, Asia -Pacific (APAC), China, Europe, Middle East and Africa (EMAE), Latin America (LATAM)
Description
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.
Product
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →