Recall Z-0508-2020— Medtronic Neuromodulation
Class I · Terminated
Class I FDA medical device recall by Medtronic Neuromodulation, initiated 2019-10-11, terminated 2023-09-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Synchromed II programmable pump, Model numbers 8637-20 and 8637-40. Reason: 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..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-10-11
- Terminated
- 2023-09-15
- Firm location
- Minneapolis, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.