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N/A 64001 (UDI 00643169936584)Recalls & reported problems

Medtronic, Inc. · ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR · Class 3 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
3

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 3 still open.

18 other recalls cover devices cleared under the same FDA submission (H020007, H050003, P960009); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. May 13, 2026Open, Classified

    A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

    Z-2241-2026 · Root cause: Under Investigation by firm · FDA record ↗

  2. May 13, 2026Open, Classified

    A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

    Z-2240-2026 · Root cause: Under Investigation by firm · FDA record ↗

  3. May 15, 2024Open, Classified

    Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.

    Z-2427-2024 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H020007, H050003, P960009. One submission often covers many models, so check the product and lot details in each record.

  • Z-0206-2025 · Sep 24, 2024 · Open, Classified
    Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
  • Z-0372-2025 · Sep 18, 2024 · Open, Classified
    Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
  • Z-0217-2024 · May 27, 2022 · Completed
    LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
  • Z-1128-2022 · Mar 30, 2022 · Open, Classified
    Percept BrainSense Implantable Neurostimulator (INS), Model B35200
  • Z-0418-2022 · Oct 19, 2021 · Open, Classified
    Model B35200 - Percept PC BrainSense Implantable Neurostimulator
  • Z-0201-2022 · Sep 23, 2021 · Open, Classified
    Clinician Programmer Application (CPA) model A610 Clinician Software Application
  • Z-1368-2021 · Mar 9, 2021 · Open, Classified
    A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.46
  • Z-3069-2017 · Mar 17, 2017 · Terminated
    DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to
  • Z-2645-2016 · Jun 23, 2016 · Terminated
    DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain
  • Z-2602-2016 · Jun 10, 2016 · Terminated
    Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
  • Z-1617-2015 · Apr 16, 2015 · Terminated
    Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
  • Z-0279-2014 · Sep 30, 2013 · Terminated
    Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
  • Z-1190-2013 · Feb 8, 2013 · Terminated
    Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system del
  • Z-0187-2009 · Jun 14, 2008 · Terminated
    Medtronic DBS" 3389 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm, Distal 9.0 mm, Medtronic, Inc. Medtronic Active Therapy includes Activa Parkinson's Control Th
  • Z-0185-2009 · Jun 14, 2008 · Terminated
    Medtronic DBS" 3389S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic. Method of Sterilization: Ethylene Ox ide

…and 3 more.

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Sources and updates

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