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Terminated

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

FDA Recall Z-0508-2020 · Posted 2019-12-03

Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeLKK
Date Initiated2019-10-11
Date Terminated2023-09-15
Product Quantity10820 units

Reason for Recall

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.

Firm Action

Medtronic Representatives began communicating to consignees starting 10/09/2019. Beginning 10/11/2019, Medtronic sent letters via mail. The letters explained the issue and requested the return of any unused units.

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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