SynchroMed II Infusion Pump (Medtronic) – Memory Corruption (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SynchroMed II Infusion Pump. Product Number: 8637-20
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
GTIN Number: 00643169630505. Serial Number: NGP004814H
Products Sold
GTIN Number: 00643169630505. Serial Number: NGP004814H
Medtronic Neuromodulation is recalling SynchroMed II Infusion Pump. Product Number: 8637-20 due to Potential for error and inability to interrogate pump due to data corruption in the pump memory.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026