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Open, Classified

SynchroMed II Infusion Pump. Product Number: 8637-20

FDA Recall Z-0137-2025 · Posted 2024-10-21

Recalling FirmMedtronic Neuromodulation
Recall StatusOpen, Classified
Product CodeLKK
Date Initiated2024-09-11
Product Quantity1 unit

Reason for Recall

Potential for error and inability to interrogate pump due to data corruption in the pump memory.

Firm Action

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

Distribution Pattern

US Nationwide distribution in the state of Mississippi.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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