Medtronic Synchromed II Pump Model 8637-20/40: Foreign Particle Risk
Medtronic recalls Synchromed II programmable pumps with model numbers 8637-20 and 8637-40 due to potential foreign particles in the motor assembly that could cause motor stalls. Affected units have specific serial numbers listed in the recall notice.
Lower-risk recall
There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.
Contact the company
What happened, in plain English
Medtronic is recalling Synchromed II programmable pumps with model numbers 8637-20 and 8637-40 because foreign particles inside the motor assembly might cause the motor to stall permanently. This could lead to device malfunction but does not pose an immediate risk of injury. Read more at govinfonow.com/recall/66795-medtronic-synchromed-ii-pump-model-8637-20-40-foreign-particle.
Source Summary by GovInfoNow · govinfonow.com/recall/66795-medtronic-synchromed-ii-pump-model-8637-20-40-foreign-particle · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0508-2020
Cite this page
“Medtronic Synchromed II Pump Model 8637-20/40: Foreign Particle Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/66795-medtronic-synchromed-ii-pump-model-8637-20-40-foreign-particle. Based on FDA recall #Z-0508-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0508-2020%22&limit=1).
Why it’s dangerous
Foreign particles inside the pump motor assembly could interfere with the motor's gear rotation, potentially causing a permanent motor stall. This might lead to device malfunction but does not involve immediate injury risks.
Who’s affected
Users of Medtronic Synchromed II pumps with model numbers 8637-20 and 8637-40 are affected. Patients using these devices for medical treatment are most at risk.
How to tell if you have this one
Check if your pump has model numbers 8637-20 or 8637-40. Affected units have specific serial numbers listed in the recall notice.
- Brand
Medtronic Neuromodulation- Category
Medical device
What to do — step by step
Check Your Pump Model
Verify your pump's model number is 8637-20 or 8637-40.
Contact Medtronic
Reach out to Medtronic for instructions on how to proceed with the recall.
How this recall unfolded
Recall timeline
FDA terminated this recall 3.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0508-2020 (October 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0508-2020 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.