Medtronic SynchroMed II Pump Recall: Data Corruption Risk
Medtronic recalls SynchroMed II Infusion Pumps (Product 8637-20) due to potential data corruption causing pump errors and inability to check settings. Affected units have specific serial numbers.
Lower-risk recall
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Contact the company
What happened, in plain English
Medtronic is recalling SynchroMed II Infusion Pumps with product number 8637-20 because data corruption in the pump memory can cause errors and prevent proper checking of settings. This could lead to incorrect medication delivery if the pump malfunctions. Read more at govinfonow.com/recall/54035-medtronic-synchromed-ii-pump-recall-data-corruption-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/54035-medtronic-synchromed-ii-pump-recall-data-corruption-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0137-2025
Cite this page
“Medtronic SynchroMed II Pump Recall: Data Corruption Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54035-medtronic-synchromed-ii-pump-recall-data-corruption-risk. Based on FDA recall #Z-0137-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0137-2025%22&limit=1).
Why it’s dangerous
Data corruption in the pump memory can cause the device to malfunction, leading to incorrect medication delivery. This may prevent healthcare providers from checking the pump's settings to ensure proper function.
Who’s affected
Patients using the SynchroMed II Infusion Pump with product number 8637-20 are affected. Those with the specific serial number NGP004814H are most at risk.
How to tell if you have this one
Check for product number 8637-20 on the pump. Affected units have serial number NGP004814H. The pump may have a specific model or version label.
- Brand
Medtronic Neuromodulation- Product
SynchroMed II Infusion Pump. Product Number: 8637-20- Category
Medical device
What to do — step by step
Check Pump Serial Number
Look for the serial number NGP004814H on the pump to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of Mississippi.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0137-2025 (September 11, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0137-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.