Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Reported: December 11, 2019 Initiated: October 11, 2019 #Z-0508-2020
Product Description
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 10820 units
- Distribution
- US and Canada, Asia -Pacific (APAC), China, Europe, Middle East and Africa (EMAE), Latin America (LATAM)
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40. Recalled by Medtronic Neuromodulation. Units affected: 10820 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 11, 2019. Severity: Critical. Recall number: Z-0508-2020.
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