Medtronic Neuromodulation
Medtronic Neuromodulation
Lower-risk recall
Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
Contact the company
What happened, in plain English
Medtronic Neuromodulation Read more at govinfonow.com/recall/55111-medtronic-neuromodulation.
Source Summary by GovInfoNow · govinfonow.com/recall/55111-medtronic-neuromodulation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2427-2024
Cite this page
“Medtronic Neuromodulation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55111-medtronic-neuromodulation. Based on FDA recall #Z-2427-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2427-2024%22&limit=1).
Why it’s dangerous
No specific danger
Who’s affected
All
How to tell if you have this one
Check for the model number and GTIN (Serial Numbers) to identify the specific device.
- Brand
Medtronic- Product
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584- Category
Medical device
What to do — step by step
What is the model number and GTIN (Serial Numbers) of the device?
The model number is 64002. The GTIN (Serial Numbers) are listed as 00613994544957, 00613994604446, 00613994604453, 00613994604460.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Canary Islands, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 3 months 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-2427-2024 (May 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2427-2024 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.