Reported Jul 31, 2024 · Ongoing
A610 Clinician Programmer (CP) Software Application (app) with the following versions
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
A610 Clinician Programmer (CP) Software Application (app) with the following versions
6 of 6 products
| # | Product as published |
|---|---|
| 1 | ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR |
| 2 | ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR |
| 3 | INS 37602 Activa SC Neurostimulator |
| 4 | INS 37603 Activa SCx Neurostimulator |
| 5 | INS B35200 DBS PERCEPT PC |
| 6 | INS B35300 PERCEPT RC V1 |
- Lot codes and dates
- VersionsVersion 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). 1. Model Number 64001
- GTIN (Serial Numbers)
1,356 of 1,356 codes
00613994544940 (N733965N733969N753252N775354N776291N778120N782773)00613994604477 (02127747780212775744021277575902127766000212793056021280462902128057180212864338021287493202128905600212890575021289521302128952140212895215021290713302129329700212932973021293297402129358970213003936021301121402130370830213103554021310383602131039470213119751021312625202131262530213126254021312625702131262580213126259021314532702132387280213238729021323873002132387310213238732021323873302132963360213296338021329663602133369830213336984021337997502133913320213403188021341072902134471870213453300021345330102134627550213462757
- GTIN (Serial Numbers)
1,359 of 1,359 codes
00613994544957 (N692230N709765N709766N709769N712972N714659N720090N721922N723172N724723N724752N730633N732361N732366N732368N732369N732369N01N734116N735283N735294N736643N736644N738447N738450N738459N740632N740717N742744N744753N744754N744756N746628N746635N748190N748193N748193N01N750163N750166N753183N755406N755416N755435N757678N757684N758562N760449N760457N760465N782607N784725N784740N784754N784755N786840N01N786849N786915N01N786917N786917N01N794131N795243
- Amount recalled
- 18,010 units
Where it was sold
- Nationwide
- PR
Why it was recalled
Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
This product could cause temporary or reversible health problems — stop using it.
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