N/A 64001 (UDI 00763000963040)Recalls & reported problems

Summary

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

2 FDA recall records name this device's identifier, 2 still open.

18 other recalls cover devices cleared under the same FDA submission (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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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-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
• 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

…and 3 more.