FDA Medical devices recall ·
SynchroMed II Infusion Pump recall
- Recall number
- Z-0137-2025
- Date
- (initiated September 11, 2024)
- Company / brand
- Medtronic Neuromodulation
7000 Central Ave Ne, Minneapolis, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SynchroMed II Infusion Pump. Product Number: 8637-20
Why was it recalled?
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN Number: 00643169630505. Serial Number: NGP004814H
Distribution
US Nationwide distribution in the state of Mississippi.
States: Mississippi
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0137-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.