Z-0137-2025 Class II Ongoing
FDA device recall Z-0137-2025 was initiated by Medtronic Neuromodulation on Sep 11, 2024 and is designated Class II. Reason for recall: Potential for error and inability to interrogate pump due to data corruption in the pump memory. The recall status is ongoing. Affected quantity: 1 unit.
Recall details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Sep 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product description
SynchroMed II Infusion Pump. Product Number: 8637-20
Reason for recall
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Distribution pattern
US Nationwide distribution in the state of Mississippi.
Code information
GTIN Number: 00643169630505. Serial Number: NGP004814H
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0137-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026