SynchroMed II Infusion Pump. Product Number: 8637-20
FDA device recall Z-0137-2025 · posted 2024-10-21 · Open, Classified
Recall details
- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- Potential for error and inability to interrogate pump due to data corruption in the pump memory.
- Action taken
- On 11-September-2024, a Medtronic representative was sent to the physician s facility where the representative provided the communication and confirmation form to the physician. The physician was asked to sign the confirmation form indicating they read the notification. The representative reset the patient s pump.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- LKK
- Quantity affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of Mississippi.
- Date initiated
- 2024-09-11
- Date posted
- 2024-10-21
- Location
- Minneapolis, MN
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