FDA Device recall Z-2427-2024
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.463…
- FDA Device
- Class II
- ongoing
- Published 2024-07-31
On 2024-07-31 the FDA classified a Class II recall of A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.463… by Medtronic Neuromodulation, citing patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2427-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-15 |
| Published | 2024-07-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 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). Includes the below product descriptions: 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
Reason
Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
Identifiers
| code_info | Versions: Version 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.…Versions: Version 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): 00613994544940 (N733965, N733969, N753252, N775354, N776291, N778120, N782773); 00613994604477 (0212774778, 0212775744, 0212775759, 0212776600, 0212793056, 0212804629, 0212805718, 0212864338, 0212874932, 0212890560, 0212890575, 0212895213, 0212895214, 0212895215, 0212907133, 0212932970, 0212932973, 0212932974, 0212935897, 0213003936, 0213011214, 0213037083, 0213103554, 0213103836, 0213103947, 0213119751, 0213126252, 0213126253, 0213126254, 0213126257, 0213126258, 0213126259, 0213145327, 0213238728, 0213238729, 0213238730, 0213238731, 0213238732, 0213238733, 0213296336, 0213296338, 0213296636, 0213336983, 0213336984, 0213379975, 0213391332, 0213403188, 0213410729, 0213447187, 0213453300, 0213453301, 0213462755, 0213462757, 0213494778, 0213503190, 0213512318, 0213512796, 021351 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Medtronic Neuromodulation
- Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002
FDA Device · Class II · 2026-06-03 · Medtronic Neuromodulation - Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001
FDA Device · Class II · 2026-06-03 · Medtronic Neuromodulation - Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A C…
FDA Device · Class II · 2026-05-20 · Medtronic Neuromodulation - A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200
FDA Device · Class II · 2026-01-21 · Medtronic Neuromodulation - Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US…
FDA Device · Class II · 2025-12-31 · Medtronic Neuromodulation
All Medtronic Neuromodulation recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2427-2024%22
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