Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
FDA device recall Z-0508-2020 · posted 2019-12-03 · Terminated
Recall details
- Recalling firm
- Medtronic Neuromodulation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LKK
- Quantity affected
- 10820 units
- Distribution
- US and Canada, Asia -Pacific (APAC), China, Europe, Middle East and Africa (EMAE), Latin America (LATAM)
- Date initiated
- 2019-10-11
- Date posted
- 2019-12-03
- Date terminated
- 2023-09-15
- Location
- Minneapolis, MN
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