SYNCHROMED II recallZ-0137-2025 · Medtronic Neuromodulation · initiated Sep 11, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0137-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 11, 2024
- Posted by the FDA
- Oct 21, 2024
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 1 unit
- Product code
- LKK
- Distribution
- US Nationwide distribution in the state of Mississippi.
Product description
SynchroMed II Infusion Pump. Product Number: 8637-20
Code information (models, lots, serial numbers)
GTIN Number: 00643169630505. Serial Number: NGP004814H
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SYNCHROMED® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls5 deaths4,303 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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